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1.  Effects of laparoscopic gastric plication (LGP) in patients with type 2 diabetes, one year follow-up 
Background
Obesity is a major risk factor for the development of type 2 diabetes mellitus. Surgery is one of the most effective treatments for morbid obesity. In a prospective cohort study, we examined the effects of Laparoscopic Gastric Plication (LGP) as a new restrictive technique on remission of type 2 diabetes mellitus.
Methods
During six years of study from June 2007 through December 2013, 62 patients who underwent bariatric surgery were recruited for our study to determine the effects of weight loss. Sixty patients with diabetes mellitus type 2 were selected for a one year follow up period. The amount of weight loss, Fasting Blood Sugar (FBS), changes in the lipid profile, HbA1c and blood pressure were assessed during this period. The primary outcomes were safety and the percentage of patients experiencing diabetes remission.
Results
Sixty patients with the mean age of 39.7 ± 12.8 years, ranging from 18 to 62 years, were enrolled in the study for an average 12 months of follow up. The maximal weight loss of 57 kg was achieved at average after six months. FBS significantly decreased during this period, and after one year, remission of diabetes was achieved in 92 % of patients. In five patients, diabetes was controlled with decrease in taking oral medications.
Conclusions
Laparoscopic Gastric Plication (LGP) resulted in significant and sustained weight loss with minimal physiologic changes in gastrointestinal tract and ameliorated blood glucose control of type 2 diabetes in morbid obese patients.
doi:10.1186/s40200-015-0188-4
PMCID: PMC4504399  PMID: 26185747
Laparoscopic gastric plication; Diabetes; Obesity; Bariatric surgery
2.  Laparoscopic Gastric Plication for the Treatment of Morbid Obesity: A Review 
Minimally Invasive Surgery  2012;2012:696348.
Introduction. Laparoscopic greater curvature plication is an operation that is gaining ground in the treatment of morbid obesity, as it appears to replicate the results of laparoscopic sleeve gastrectomy with fewer complications. Aim. Review of current literature, especially results on weight loss and complications. Method. 11 (eleven) published articles on laparoscopic gastric plication, of which 1 preclinical study, 8 prospective studies for a total of 521 patients and 2 case reports of unusual complications. Results. Reported Paracentage of EWL in all studies is comparable to Laparoscopic Sleeve Gastrectomy (around 50% in 6 months, 60–65% in 12 months, 60–65% in 24 months) and total complication rate is at 15,1% with minor complications in 10,7%, major complications in 4,4%. Reoperation rate was 3%, conversion rate was 0,2%, and mortality was zero. Conclusion. Current literature on gastric plication and its modifications is limited and sketchy at times. Low cost, short hospital stay, absence of prosthetic material, and reversibility make it an attractive option. Initial data show that LGCP is effective for short- and medium-term weight loss, complication and reoperation rates are low, and GERD symptoms are unaffected. More data is required, and randomized control trials must be completed in order to reach safe conclusions.
doi:10.1155/2012/696348
PMCID: PMC3397205  PMID: 22811900
3.  Comparison of laparoscopic sleeve gastrectomy and laparoscopic gastric plication: One year follow-up results 
Objective:
Various different surgical methods are used for obesity surgery. Among them, laparoscopic sleeve gastrectomy (LSG) and laparoscopic gastric plication (LGP) have been both successfully performed in recent years. In this study, we compared the treatment results of patients who underwent LGP, a method that was introduced later consisting of plication of gastric greater curvature to achieve volume reduction, with results of patients who underwent LSG.
Material and Methods:
We analyzed data on morbid obese patients who underwent bariatric surgery with either LSG or LPG in Konya Beyhekim Hospital between 2009 and 2012. Demographic features including age and sex, preoperative blood biochemistry, body mass index (BMI) before and after operation, duration of hospital stay, morbidity, mortality and complications were analyzed.
Results:
Fifty-five patients who were operated for obesity between 2009 and 2012 were included in the study. 29 patients underwent LGP, and 26 patients LSG. The BMI in the LGP and LSG groups was 41.4±3 kg/m2 and 42.0±3.1 kg/m2, respectively. There was no significant difference between two groups in terms of BMI. Two groups were also similar in terms of age and gender. In the LGP group, one patient had postoperative necrosis of the suture line. One patient in the LSG group was re-operated due to bleeding. Another patient in this group had leakage at the suture line. Postoperative BMI assessment of groups revealed significantly lower BMI levels in the LSG group. Length of hospital stay was significantly shorter in the LGP group. There was no significant difference in complication rates between two groups.
Conclusion:
In this study, we obtained similar results in patients who were treated with LGP or LSG. Moreover, LSG was more efficient in decreasing BMI in morbid obesity surgery when compared to LGP. However, duration of hospital stay was significantly shorter in LGP group. We concluded that both methods could be effectively and safely used in the surgical management of morbid obesity.
doi:10.5152/UCD.2015.2991
PMCID: PMC4771421  PMID: 26985155
Obesity; sleeve; plication; laparoscopic
4.  Laparoscopic gastric plication and its effect on saccharide and lipid metabolism: a 12-month prospective study 
Introduction
Laparoscopic greater curvature plication (LGCP) is a novel restrictive technique that reduces gastric volume by plication of the greater curvature. The advantage of LGCP is its reversibility in comparison to laparoscopic sleeve gastrectomy. Nowadays, the long-term LGCP efficacy, safety and metabolic effect are being investigated.
Aim
To assess body composition, clinical complications and metabolic changes in obese patients 6 and 12 months after laparoscopic greater curvature plication.
Material and methods
A total of 70 subjects underwent LGCP; 52 of them (33 women and 19 men) completed 1-year follow-up study. Anthropometry and biochemical parameters (glucose, glycated haemoglobin, lipids, ghrelin, leptin, adiponectin and fibroblast growth factor 21 [FGF-21]) were assessed before and 3, 6, and 12 months after surgery.
Results
All study participants exhibited statistically significant weight loss at both 6 and 12 months following the LGCP compared to baseline, with significant reductions in body composition – body weight, body mass index, percentage excess weight loss (%EWL), and percentage excess BMI loss (%EBL) (p ≤ 0.001). Moreover, significant lowering of glucose and glycated haemoglobin, triacylglycerols and leptin was observed 12 months after LGCP. On the other hand, plasma concentrations of ghrelin, adiponectin and LDL cholesterol increased significantly. Total cholesterol, LDL cholesterol and FGF-21 levels did not change significantly.
Conclusions
Laparoscopic greater curvature plication appears to be a procedure with good restriction results, which might be mediated through alteration in incretin metabolism. Technical aspects and standardization of the procedure still remain to be worked out.
doi:10.5114/wiitm.2015.54103
PMCID: PMC4653266  PMID: 26649086
weight loss; ghrelin; fibroblast growth factor 21; metabolic effect; gastric plication
5.  Gastric Plication Can Reduce Slippage Rate After Laparoscopic Gastric Banding 
Laparoscopic gastric plication appears to add security to gastric band application and reduce the incidence of slippage after this procedure.
Background:
Laparoscopic insertion of a gastric band for weight reduction is increasingly performed in obese and morbidly obese patients. Complication rates after gastric band insertion are reduced by using certain techniques.
Patients and Methods:
This was a prospective study of all patients who underwent laparoscopic adjustable gastric band (LAGB) insertion at our unit. This procedure is performed through the classical 4-port technique and the use of a liver retractor. The pars flaccida method is performed in all patients, and the gold finger, a malleable instrument, is used to guide the band through the retroesophageal window in patients with difficult anatomy. Band slippage is avoided by using 2 types of gastric plication, depending on the anatomical characteristics of the stomach. Outcomes and morbidity are recorded, and patients are followed up in outpatient clinics.
Results:
Laparoscopic adjustable gastric band (LAGB) insertion was performed in 464 patients. A single consultant surgeon performed all procedures over a 2-year period. From August 2005 through August 2007, 380 (81.89%) women and 84 (18.10%) men were included in this study. The mean age was 41 years (range, 21 to 62). The mean body mass index was 43 (range, 35 to 62). Morbidity included dysphagia, epigastric pain, port displacement, port infection, erosion, and acute respiratory distress. Only one (0.21%) case of band slippage was reported. The mean follow-up was 26 months (range, 18 to 42).
Conclusion:
Laparoscopic gastric plication adds greater security and provides optimum gastric band placement. It is an effective method to reduce slippage after gastric band insertion.
doi:10.4293/108680810X12785289144241
PMCID: PMC3043572  PMID: 20932373
Laparoscopic gastric band; Plication technique; Anterior slippage; Posterior slippage; Longitudinal plication; Transverse plication; Oblique plication; Gastro-gastric stitches
6.  Laparoscopic Greater Curve Plication as an Outpatient Weight Loss Procedure 
Background and Objectives:
Laparoscopic greater curve plication is emerging as a weight loss procedure that avoids many of the complications of other surgeries that require gastrointestinal division, amputation, or use of a foreign body. Cost savings and affordability have also been promoted, as plication does not require the use of stapling devices, adjustable gastric bands, or prolonged hospitalization. The ability to predictably perform plication as an outpatient surgery may further define its role as a therapeutic option for treating morbid obesity. We present the 30-day outcomes and supplementary 12-month data in a series of 141 laparoscopic greater curve plication surgeries performed as outpatient procedures.
Methods:
Laparoscopic greater curve plication was performed as outpatient surgery in 141 consecutive patients. Outcomes including perioperative complications, incidental 12-month follow-up for weight loss, and change in diabetic and hypertensive medication are reported.
Results:
Of the 141 plications performed, 138 patients were discharged from the recovery room and 6 were readmitted. There was no conversion to open surgery and no mortality.
Conclusions:
The ability to reliably perform greater curve plication as an outpatient surgery may further define its role as an additional weight loss surgery technique.
doi:10.4293/JSLS.2015.00054
PMCID: PMC4589905  PMID: 26508824
Bariatric; Gastric; Laparoscopic; Outpatient; Plication
7.  Laparoscopic sleeve gastrectomy in management of weight regain after failed laparoscopic plication☆ 
INTRODUCTION
Weight regain after bariatric surgery remains a challenging problem with regard to its surgical management.
PRESENTATION OF CASE
A 30 year-old-female patient with weight regain after failed laparoscopic gastric plication and previous gastric banding was evaluated in a tertiary-care university setting. Her last body mass index was calculated as 40.4 kg/m2. Preoperative ultrasonography revealed cholelithiasis. Laparoscopic sleeve gastrectomy with cholecystectomy was planned as a redo surgery. A floopy and plicated stomach with increased wall thickness of the greater curvature was seen. After adhesiolysis between the plicated part of stomach and the surrounding omental tissues, concomitant laparoscopic sleeve gastrectomy and cholecystectomy were performed. She was discharged on the 4th post-operative day without any complaint. At the postoperative 3rd month, her body mass index was recorded as 24 kg/m2.
DISCUSSION
Redo surgery of morbid obesity after failed bariatric surgery is a technically demanding issue. Type of the surgical treatment should be decided by the attending surgeon based on the morphology of the remnant stomach caused by previous operations.
CONCLUSION
As a redo surgery after failed laparoscopic gastric plication and gastric banding procedures, laparoscopic sleeve gastrectomy may be regarded as a safe and feasible approach in experienced hands.
doi:10.1016/j.ijscr.2013.07.020
PMCID: PMC3785862  PMID: 23973898
Bariatric surgery; Sleeve gastrectomy; Gastric plication; Weight regain
8.  Three-Year Experience of Pouch Dilatation and Slippage Management after Laparoscopic Adjustable Gastric Banding 
Yonsei Medical Journal  2013;55(1):149-156.
Purpose
Pouch dilatation and band slippage are the most common long-term complications after laparoscopic adjustable gastric banding (LAGB). The aim of the study is to present our experience of diagnosis and management of these complications.
Materials and Methods
The pars flaccida technique with anterior fixation of the fundus was routinely used. All band adjustments were performed under fluoroscopy. We analyzed the incidence, clinico-radiologic features, management, and revisional surgeries for treatment of these complications. We further presented the outcome of gastric plication techniques as a measure for prevention of these complications.
Results
From March 2009 to March 2012, we performed LAGB on 126 morbidly obese patients. Among them, 14 patients (11.1%) were diagnosed as having these complications. Four patients (3.2%) had concentric pouch dilatations, which were corrected by band adjustment. Ten (7.9%) had eccentric pouch with band slippage. Among the ten patients, there were three cases of posterior slippage, which were corrected by reoperation, and seven cases of eccentric pouch dilatation with anterior slippage. Three were early anterior slippage, which was managed conservatively. Two were acute anterior slippage, one of whom underwent a revision. There were two cases of chronic anterior slippage, one of whom underwent a revision. The 27 patients who underwent gastric plication did not present with eccentric pouch with band slippage during the follow-up period.
Conclusion
The incidence of pouch dilatation with/without band slippage was 11.1%. Management should be individualized according to clinico-radiologic patterns. Gastric plication below the band might prevent these complications.
doi:10.3349/ymj.2014.55.1.149
PMCID: PMC3874894  PMID: 24339300
Pouch dilatation; band slippage; laparoscopic adjustable gastric band
9.  Laparoscopic Adjustable Gastric Band: How to Reduce the Early Morbidity 
Background:
Laparoscopic adjustable gastric band insertion is a safe weight reduction procedure, but serious complications can develop. The aim of this study was to evaluate our technique in preventing early band complications.
Methods:
Patients were given the choice of procedure according to body mass index, the presence of diabetes, and preference. Weight loss data were not considered, as our aim was to evaluate the morbidity of band surgery using a specific technique. A pars flaccida approach and plication technique were used for all patients. Postoperative follow-up was provided at 1 month, 2 months, and every 3 months for the first year and then yearly for a further 2 years. Thereafter, general practitioners referred patients if late complications arose.
Results:
From January 2007 to August 2011, 1149 patients (245 men [21.32%], 904 women [78.67%]) underwent laparoscopic adjustable gastric band insertion under the care of a single bariatric surgeon. Patients were hospitalized for 1 night only unless they developed early complications. The primary and secondary outcomes were major and minor band complications, respectively. Patients' age range was 18 to 64 years (mean, 44 years). Body mass index ranged from 33 to 62 kg/m2 (mean, 42 kg/m2). There were 2 band erosions (0.17%), 6 cases of band prolapse (0.52%), 4 port problems (0.34%), 1 band leak (0.08%), 3 tight bands (0.26%), 2 port infections (0.17%), and no deaths. Five procedures (0.43%) were abandoned and excluded from this study, and 1 (0.17%) was converted to minilaparotomy to control abdominal wall bleeding. The duration of follow-up ranged from 16 to 60 months.
Conclusions:
A combined pars flaccida and plication technique is associated with a low early complication rate.
doi:10.4293/JSLS.2014.00241
PMCID: PMC4154413  PMID: 25392623
Laparoscopic adjustable gastric band; Body mass index; pars flaccida
10.  AB 64. Early hemi-diaphragmatic plication through a video assisted mini-thoracotomy in postcardiotomy phrenic nerve paresis 
Journal of Thoracic Disease  2012;4(Suppl 1):AB64.
Background
New symptom onset of respiratory distress without other cause, and new hemi-diaphragmatic elevation on chest radiography postcardiotomy, are usually adequate for the diagnosis of phrenic nerve paresis. The symptom severity varies (asymptomatic state to severe respiratory failure) depending on the degree of the lesion (paresis vs. paralysis), the age, and the co-morbidity (respiratory/cardiac disease, morbid obesity, etc.) Surgical treatment (hemi-diaphragmatic plication) is indicated only in the presence of symptoms. The timing of surgery depends on the severity and the progression of symptoms. In infants and young children with postcardiotomy phrenic nerve paresis the clinical status is usually severe (failure to wean from mechanical ventilation), and early plication is indicated. Adults with postcardiotomy phrenic nerve paresis usually suffer from chronic dyspnoea, and, in the absence of respiratory distress, conservative treatment is recommended for 6 months -2 years, since improvement is often observed. Nevertheless, earlier surgical treatment is indicated in non-resolving respiratory failure. We present early hemi-diaphragmatic plication, in a high risk patient with postcardiotomy phrenic nerve paresis.
Patient and methods
A 72 year old woman, with bioprosthetic mitral valve endocarditis, native aortic valve endocarditis, and acute renal failure, underwent urgent redo mitral valve replacement and aortic valve replacement (predicted mortality Euroscore II: 23.86%). Despite good valve and cardiac function, infection control, and weaning from mechanical ventilation she had respiratory failure (dyspnoea, tachypnoea, orthopnoea, hypoxaemia, need continuous oxygen supplementation). Chest radiography revealed a new right hemi-diaphragm elevation, with severe progressing lung atelectasis. Right hemi-diaphragm postero-anterior plication was performed through a video assisted right mini-thoracotomy on the 25th postoperative day.
Results
Early extubation was achieved, adequate respiratory function was established, chest radiography was normalized (normal right hemi-diaphragm position, right lung expansion). After mobilization and rehabilitation the patient was discharged home on the 8th day after plication.
Conclusions
Several techniques and approaches are employed for diaphragmatic plication (thoracotomy, video-assisted thoracoscopic surgery, video-assisted mini-thoracotomy, laparoscopic surgery). The early plication through a video assisted mini-thoracotomy was safe and effective, offering minimal surgical trauma, short operative time, minimal blood loss and postoperative pain, leading to fast rehabilitation and avoidance of prolonged hospitalization complications.
doi:10.3978/j.issn.2072-1439.2012.s064
PMCID: PMC3537436
11.  Early Results of Trans-Oral Endoscopic Plication and Revision of the Gastric Pouch and Stoma following Roux-en-Y Gastric Bypass Surgery 
In patients with severe gastroesophageal reflux disease post gastric bypass surgery, endoscopic plication with revision of the gastric pouch may be beneficial.
Objective:
A new technique for endoscopic plication and revision of the gastric pouch (EPRGP) for patients who underwent gastric bypass (RGB) surgery was evaluated in patients with severe GERD, dumping syndrome, failure of weight loss, or all of these.
Patients and Methods:
Patients underwent EPRGP over a 12-month period. The StomaphyX device (Endogastric Solutions, Redmond, WA) was utilized over a standard flexible gastroscope. Patients were kept on a liquid diet for 1 week.
Results:
The study included 64 patients with a mean age of 48 years who underwent 67 procedures. EPRGP was performed an average of 5 years after RGB. The mean preoperative BMI was 39.5 kg/m2. The primary indications for the procedure were inadequate weight loss, dumping syndrome (42), and GERD (15). The mean follow-up period was 5.8 months (range, 3 to 12). The average operative time was 50 minutes, with a significant reduction with increased operator experience. There were only 2 (3%) intraoperative complications during the early period (equipment failure), which did not result in any morbidity. All symptoms from dumping syndrome or reflux improved, with no further operative-related complications. The mean weight loss was 7.3kg.
Conclusions:
This study demonstrates the technical feasibility, safety, and efficacy of EPRGP.
doi:10.4293/108680810X12785289144197
PMCID: PMC3043571  PMID: 20932372
Gastric bypass; Bariatric; Natural orifice; Revision; Endoscopic; Plication
12.  Using the StomaphyXTM Endoplicator to Treat a Gastric Bypass Complication 
Rapid advances in endoluminal technology such as tissue placating devices offer an alternative for repair of some postbariatric surgical complications.
Background and Objectives:
As the number of bariatric operations performed increases, the number of patients requiring reoperation for failed weight loss is expected to proportionately increase. Natural orifice surgery is an alternative approach to revisional gastric bypass surgery when postoperative complications, such as dilatation of the gastrojejunostomy, gastrogastric fistula, and gastric pouch, dilation occur.
Methods:
The present article reports on the safe and successful use of an endoscopic tissue plicating device in a patient found to have a dilated gastric pouch and a gastrogastric fistula 12 years after an open, nondivided RYGB.
Results:
The procedure was performed without complications and resulted in a reduced pouch size to approximately 30cc to 50cc and redirection of the flow of gastric contents through her gastrojejunostomy. The patient's early satiety returned and, 1 year postoperatively, she had incurred a 45-pound weight loss.
Discussion:
The morbidity and mortality of revision gastric bypass was avoided while the patient's goal of moderate weight loss was achieved. Tissue plicating devices offer an alternative for repair of some postbariatric complications. With the rapid advances in endoluminal technology and increasing experience with natural orifice surgery, the ability to successfully address surgical problems through less invasive means will continue to improve.
doi:10.4293/108680811X13022985131570
PMCID: PMC3134684  PMID: 21902955
Bariatric surgery; Complications; Fistula; Endoscopy
13.  Neoumbilicoplasty is a useful adjuvant procedure in abdominoplasty 
BACKGROUND:
Neoumbilicoplasties are indicated in congenital conditions associated with umbilical agenesis, umbilical loss due to inflammatory destruction, excision of skin cancer involving the umbilical stump and in surgical procedures for herniorrhaphy, as well as in the rare condition of umbilical endometriosis.
OBJECTIVE:
Neoumbilicoplasty is an adjuvant procedure that may be necessary during abdominoplasty with wide myofascial plication, or repair of concomitant hernias of the abdominal wall. The present article justifies sacrificing the umbilicus followed by neoumbilicoplasty in patients with significant wide myofascial plication or concomitant hernias of the abdominal wall.
METHODS:
Seventeen patients underwent a combination of abdominoplasty and wide (greater than 10 cm) vertical plication of the myofascial complex and required neoumbilicoplasty. The male to female ratio was 1:16; mean age was 44 years, mean weight 94.1 kg and mean height 160.2 cm. Characteristic body morphology included gross trunk obesity with a prominent anterior abdominal wall.The female patients were multiparous. Sacrificing the umbilici followed by neoumbilicoplasty was required in patients with umbilical hernias and patients who had divarication of the rectus abdominis muscles with short umbilical stumps.
RESULTS:
Nine patients had concomitant ventral hernias (52.94%) and eight patients had divarication of the rectus abdominis muscles with short umbilical stumps (47.05%). The mean perioperative myofascial plication distance was 15.41 cm and the gap closure required three to five rows of sutures.
CONCLUSION:
Neoumbilicoplasty is a useful adjuvant procedure during abdominoplasty with wide myofascial plication or repair of concomitant hernias of the abdominal wall.
PMCID: PMC2827282  PMID: 21119826
Abdominal hernias; Abdominoplasty; Myofascial plication; Musculoaponeurotic plication; Neoumbilicoplasty
14.  AB025. Surgical treatment for Peyronie’s disease in Japan 
Translational Andrology and Urology  2015;4(Suppl 1):AB025.
Objective
The prevalence of Peyronie’s Disease is 2 to 8.9% average 5%. Thus, PD is not rare disease. We will show the 17 years’ experience in Toho University.
Methods
We had 344 cases for 17 years. The average age was 51.4 years. Chief complains were curvature, palpable fibrosis, pain, ED etc. The angle of curvature was 0 to 90 degrees. About direction of curvature, 34% was upper direction, 17% were left direction and lower direction, 11% was right direction. One hundred and twenty cases (35%) were improved by medication. We usually use Tranilast as medication. Tranilast is used for Keloid and hypertrophic scar in Japan. The mechanism is suppression of TGF-β. Operations were performed after conservative treatment for 1 year. We had two operation methods, plication and grafting. After shaving tunica, we make inverted plication suture using nonabsorble 2-0 Tycron. We have two methods of saphenous vein graft. If plaque is small, we performed vein graft after plaque excision. If plaque is large, we performed rectangle type vein graft after Hourglass-shaped incision. We performed dermal graft for large defect and lateral defect.
Results
Ninety-three cases (27%) were performed saphenous vein graft. Seven cases (2%) were performed dermal graft. Fifty-two cases (15%) were performed plication. Satisfaction rate was 91.8%. Slight curvature remain was 6.1%. Complain short penis was 2.1%. Complication rate with ED was 0%.
Conclusions
(I) Vein graft is better than plication method for Peyronie’s disease with penis shortening; (II) vein is the best as material for grafting, because the grafted vein is thin and soft; (III) the hourglass-shaped incision method is most suitable for cases of a wide plaque; (IV) we need dermal graft for large defect due to calcification of tunica and lateral defect; (V) plication method for PD with mild or moderate ED is safety, because cavernous artery from dorsal artery is cut at dorsal grafting.
doi:10.3978/j.issn.2223-4683.2015.s025
PMCID: PMC4708824
Peyronie’s disease; placation; saphenous vein graft; dermal graft
15.  Early hemi-diaphragmatic plication through a video assisted mini-thoracotomy in postcardiotomy phrenic nerve paresis 
Journal of Thoracic Disease  2012;4(Suppl 1):56-68.
New symptom onset of respiratory distress without other cause, and new hemi-diaphragmatic elevation on chest radiography postcardiotomy, are usually adequate for the diagnosis of phrenic nerve paresis. The symptom severity varies (asymptomatic state to severe respiratory failure) depending on the degree of the lesion (paresis vs. paralysis), the laterality (unilateral or bilateral), the age, and the co-morbidity (respiratory, cardiac disease, morbid obesity, etc). Surgical treatment (hemi-diaphragmatic plication) is indicated only in the presence of symptoms. The established surgical treatment is plication of the affected hemidiaphragm which is generally considered safe and effective. Several techniques and approaches are employed for diaphragmatic plication (thoracotomy, video-assisted thoracoscopic surgery, video-assisted mini-thoracotomy, laparoscopic surgery). The timing of surgery depends on the severity and the progression of symptoms. In infants and young children with postcardiotomy phrenic nerve paresis the clinical status is usually severe (failure to wean from mechanical ventilation), and early plication is indicated. Adults with postcardiotomy phrenic nerve paresis usually suffer from chronic dyspnoea, and, in the absence of respiratory distress, conservative treatment is recommended for 6 months -2 years, since improvement is often observed. Nevertheless, earlier surgical treatment may be indicated in non-resolving respiratory failure. We present early (25th day postcardiotomy) right hemi-diaphragm plication, through a video assisted mini-thoracotomy in a high risk patient with postcardiotomy phrenic nerve paresis and respiratory distress. Early surgery with minimal surgical trauma, short operative time, minimal blood loss and postoperative pain, led to fast rehabilitation and avoidance of prolonged hospitalization complications. The relevant literature is discussed.
doi:10.3978/j.issn.2072-1439.2012.s007
PMCID: PMC3537434  PMID: 23304442
Respiratory paralysis/surgery; respiratory paralysis/etiology; dyspnea/etiology; diaphragm/surgery; phrenic nerve/injuries
16.  Laparoscopic adjustable banded roux-en-y gastric bypass as a primary procedure for the super-super-obese (body mass index > 60 kg/m2) 
BMC Surgery  2010;10:33.
Background
Currently, there is no consensus opinion regarding the optimal procedure of choice in super-super-morbid obesity (Body mass index, BMI > 60 kg/m2). Roux-en-Y gastric bypass (RYGB) is associated with failure to achieve or maintain 50% excess weight loss (EWL) or BMI < 35 in approximately 15% of patients. Also, percent EWL is significantly less after 1-year in the super-super-obese group as compared with the less obese group and many patients are still technically considered to be obese (lowest post-surgical BMI > 35) following RYGB surgery in this group. The addition of adjustable gastric band (AGB) to RYGB has been reported as a revisional procedure but this combined bariatric procedure has not been explored as a primary operation.
Methods
In a primary laparoscopic RYGB, an AGB is drawn around the gastric pouch through a small opening between the blood vessels on the lesser curve and the gastric pouch. The band is then fixed by suturing the gastric remnant to the gastric pouch both above and below the band to prevent slippage.
Results
Between November 2009 and March 2010, 6 consecutive super-super-obese patients underwent a primary laparoscopic adjustable banded Roux-en-Y gastric bypass procedure at our institution. One male patient (21 years, BMI 70 kg/m²) developed a pneumonia postoperatively. No other postoperative complications were observed.
Conclusion
To the best of our knowledge, this is the first series of patients that underwent a laparoscopic adjustable banded RYGB as a primary operation for the super-super obese in the indexed literature. With the combined procedure, a sequential action mechanism for weight loss is to be expected. The restrictive, malabsorptive and hormonal working mechanism of the RYGB will induce weight loss from the start reaching a stabilised plateau of weight after 12 - 18 months. At that time, filling of the band can be started resulting in further gastric pouch restriction and increased weight loss. Moreover, besides improving the results of total weight loss, a gradual filling of the band can as well prevent the RYGB patient from weight regain if restriction would fade away with time.
doi:10.1186/1471-2482-10-33
PMCID: PMC2992483  PMID: 21073750
17.  Gastric Electrical Stimulation 
Executive Summary
Objective
The objective of this analysis was to assess the effectiveness, safety and cost-effectiveness of gastric electrical stimulation (GES) for the treatment of chronic, symptomatic refractory gastroparesis and morbid obesity.
Background
Gastroparesis - Epidemiology
Gastroparesis (GP) broadly refers to impaired gastric emptying in the absence of obstruction. Clinically, this can range from the incidental detection of delayed gastric emptying in an asymptomatic person to patients with severe nausea, vomiting and malnutrition. Symptoms of GP are nonspecific and may mimic structural disorders such as ulcer disease, partial gastric or small bowel obstruction, gastric cancer, and pancreaticobiliary disorders.
Gastroparesis may occur in association with diabetes, gastric surgery (consequence of peptic ulcer surgery and vagotomy) or for unknown reasons (idiopathic gastroparesis). Symptoms include early satiety, nausea, vomiting, abdominal pain and weight loss. The majority of patients with GP are women.
The relationship between upper gastrointestinal symptoms and the rate of gastric emptying is considered to be weak. Some patients with markedly delayed gastric emptying are asymptomatic and sometimes, severe symptoms may remit spontaneously.
Idiopathic GP may represent the most common form of GP. In one tertiary referral retrospective series, the etiologies in 146 GP patients were 36% idiopathic, 29% diabetic, 13% postgastric surgery, 7.5% Parkinson’s disease, 4.8% collagen vascular disorders, 4.1% intestinal pseudoobstruction and 6% miscellaneous causes.
The true prevalence of digestive symptoms in patients with diabetes and the relationship of these symptoms to delayed gastric emptying are unknown. Delayed gastric emptying is present in 27% to 58% of patients with type 1 diabetes and 30% with type 2 diabetes. However, highly variable rates of gastric emptying have been reported in type 1 and 2 diabetes, suggesting that development of GP in patients with diabetes is neither universal nor inevitable. In a review of studies examining gastric emptying in patients with diabetes compared to control patients, investigators noted that in many cases the magnitude of the delay in gastric emptying is modest.
GP may occur as a complication of a number of different surgical procedures. For example, vagal nerve injury may occur in 4% to 40% of patients who undergo laparoscopic fundoplication1 for gastroesophageal reflux disease.
The prevalence of severe, refractory GP is scantily reported in the literature. Using data from a past study, it has been estimated that the prevalence of severe, symptomatic and refractory GP in the United States population is 0.017%. Assuming an Ontario population of 13 million, this would correspond to approximately 2,000 people in Ontario having severe, symptomatic, refractory GP.
The incidence of severe refractory GP estimated by the United States Food and Drug Administration (FDA) is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year.
Treatment for Gastroparesis
To date, there have been no long-term studies confirming the beneficial effects of maintaining euglycemia on GP symptoms. However, it has been suggested that consistent findings of physiologic studies in healthy volunteers and diabetes patients provides an argument to strive for near-normal blood glucose levels in affected diabetes patients.
Dietary measures (e.g., low fibre, low fat food), prokinetic drugs (e.g., domperidone, metoclopramide and erythromycin) and antiemetic or antinausea drugs (e.g, phenothiazines, diphenhydramine) are generally effective for symptomatic relief in the majority of patients with GP.
For patients with chronic, symptomatic GP who are refractory to drug treatment, surgical options may include jejunostomy tube for feeding, gastrotomy tube for stomach decompression and pyloroplasty for gastric emptying.
Few small studies examined the use of botulinum toxin injections into the pyloric sphincter. However, the contribution of excessive pyloric contraction to GP has been insufficiently defined and there have been no controlled studies of this therapy.
Treatment with GES is reversible and may be a less invasive option compared to stomach surgery for the treatment of patients with chronic, drug-refractory nausea and vomiting secondary to GP. In theory, GES represents an intermediate step between treatment directed at the underlying pathophysiology, and the treatment of symptoms. It is based on studies of gastric electrical patterns in GP that have identified the presence of a variety of gastric arrhythmias. Similar to a cardiac pacemaker, it was hypothesized that GES could override the abnormal rhythms, stimulate gastric emptying and eliminate symptoms.
Morbid Obesity Epidemiology
Obesity is defined as a body mass index (BMI) of at last 30 kg/m2. Morbid obesity is defined as a BMI of at least 40 kg/m2 or at least 35 kg/m2 with comorbid conditions. Comorbid conditions associated with obesity include diabetes, hypertension, dyslipidemias, obstructive sleep apnea, weight-related arthropathies, and stress urinary incontinence.
In the United States, the age-adjusted prevalence of extreme obesity (BMI ≥ 40 kg/m2) for adults aged 20 years and older has increased significantly in the population, from 2.9% (1988–1994) to 4.7% (1999–2000). An expert estimated that about 160,000 to 180,000 people are morbidly obese in Ontario.
Treatment for Morbid Obesity
Diet, exercise, and behavioural therapy are used to help people lose weight.
Bariatric surgery for morbid obesity is considered an intervention of last resort for patients who have attempted first-line forms of medical management.
Gastric stimulation has been investigated for the treatment of morbid obesity; the intention being to reduce appetite and induce early satiety possibly due to inhibitory effects on gastric motility and effects on the central nervous system (CNS) and hormones related to satiety and/or appetite.
Possible advantages to GES for the treatment of morbid obesity include reversibility of the procedure, less invasiveness than some bariatric procedures, e.g., gastric bypass, and less side effects (e.g., dumping syndrome).
The Device
Electrical stimulation is delivered via an implanted system that consists of a neurostimulator and 2 leads. The surgical procedure can be performed via either an open or laparoscopic approach. An external programmer used by the physician can deliver instructions to the GES, i.e., adjust the rate and amplitude of stimulation (Figure 1). GES may be turned off by the physician at any time or may be removed. The battery life is approximately 4-5 years
For treatment of GP, the GES leads are secured in the muscle of the lower stomach, 10 cm proximal to the pylorus (the opening from the stomach to the intestine), 1 cm apart and connected to an implantable battery-powered neurostimulator which is placed in a small pocket in the abdominal wall
For treatment of morbid obesity, GES leads are implanted along the lesser curvature of the stomach where the vagal nerve branches spread, approximately 8 cm proximal to the pylorus. However, the implant positioning of the leads has been variably reported in the literature.
Regulatory Status
The Enterra Therapy System and the Transcend II Implantable Gastric Stimulation System (Medtronic Inc.) are both licensed as class 3 devices by Health Canada (license numbers 60264 and 66948 respectively). The Health Canada indications for use are:
Enterra Therapy System
“For use in the treatment of chronic intractable (drug-refractory) nausea and vomiting.”
Transcend II Implantable Gastric Stimulation System
“For use in weight reduction for obese adults with a body mass index greater than 35.”
The GES device that is licensed by Health Canada for treatment of GP, produces high-frequency GES. Most clinical studies examining GES for GP have used high-frequency (4 times the intrinsic slow wave frequency, i.e., 12 cycles per minute), low energy, short duration pulses. This type of stimulation does not alter gastric muscular contraction and has no effect on slow wave dysrhythmias. The mechanism of action is unclear but it is hypothesized that high-frequency GES may act on sensory fibers directed to the CNS.
The GES device licensed by Health Canada for treatment of morbid obesity produces low-frequency GES, which is close to or just above the normal/native gastric slow wave cycle (approximately 3 cycles/min.). This pacing uses low-frequency, high-energy, long-duration pulses to induce propagated slow waves that replace the spontaneous ones. Low-frequency pacing does not invoke muscular contractions.
Most studies examining the use of GES for the treatment of morbid obesity use low-frequency GES. Under normal circumstances, the gastric slow wave propagates distally and determines the frequency and propagation direction of gastric peristalsis. Low-frequency GES aims to produce abnormal gastric slow waves that can induce gastric dysrhythmia, disrupt regular propagation of slow waves, cause hypomotility of the stomach, delay gastric emptying, reduce food intake, prolong satiety, and produce weight loss.
In the United States, the Enterra Therapy System is a Humanitarian Use Device (HUD), meaning it is a medical device designated by the FDA for use in the treatment of medical conditions that affect fewer than 4,000 individuals per year.2 The Enterra Therapy System is indicated for “the treatment of chronic, drug- refractory nausea and vomiting secondary to GP of diabetes or idiopathic etiology” (not postsurgical etiologies).
GES for morbid obesity has not been approved by the FDA and is for investigational use only in the United States.
Review Strategy
The Medical Advisory Secretariat systematically reviewed the literature to assess the effectiveness, safety, and cost-effectiveness of GES to treat patients who have: a) chronic refractory symptomatic GP; or b) morbid obesity.
The Medical Advisory Secretariat used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases.
The GRADE approach was used to systematically and explicitly make judgments about the quality of evidence and strength of recommendations.
Findings
As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence in Tables 1 and 2.
GRADE Quality of Studies – Gastroparesis
Confounders related to diabetes.
Possible Type 2 error for subgroup analyses.
Subjective self-reported end point.
Posthoc change in primary end point analysis.
No sample size justification.
Concomitant prokinetic/antiemetic therapy.
Only 1 RCT (with different results for FDA and publication).
GES originally hypothesized to correct gastric rhythms, stimulate gastric emptying and therefore eliminate symptoms.
Now hypothesized to directly act on neurons to the CNS to control symptoms.
Weak correlation between symptoms and gastric emptying.
Unclear whether gastric emptying is still considered an end point to investigate.
GRADE Quality of Studies – Morbid Obesity
No sample size calculation.
Small sample size.
No ITT analysis.
Lack of detail regarding dropouts.
Possible Type 2 error.
Sparse details about randomization/blinding.
Full, final results not published.
Only 1 RCT (technically grey literature).
Economic Analysis
No formal economic analysis was identified in the literature search.
The Alberta Heritage Foundation for Medical Research reported that the cost of implanting a GES in the United States for the treatment of GP is estimated to be $30,000 US. In Canada, the device costs approximately $10,700 Cdn; this does not include costs associated with the physician’s training, the implantation procedure, or device programming and maintenance.
Ontario Context
There is no Schedule of Benefits code for GES.
There is no Canadian Classification of Health Interventions Index (CCI) procedure code for GES.
Since the ICD-10 diagnosis code for gastroparesis falls under K31.8 “Other specified diseases of the stomach and duodenum”, it is impossible to determine how many patients in Ontario had discharge abstracts because of gastroparesis.
In 2005, there were less than 5 out-of-country requests for GES (for either consultation only or for surgery).
Gastroparesis
The prevalence of severe, refractory GP is variably reported in the literature.
The Alberta Heritage Foundation for Medical Research estimated that the prevalence of severe, symptomatic and medically refractory GP in the United States population was 0.017%. Assuming a total Ontario population of 13 million, this would correspond to a budget impact of approximately $23.6 M
Cdn ($10,700 Cdn x 2,210 patients) for the device cost alone.
The incidence of severe refractory GP estimated by the FDA is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year. This corresponds to a budget impact of approximately $107,000 Cdn to $1.6M Cdn per year for the device cost alone.
Morbid Obesity
An expert in the field estimated that there are 160,000 to 180,000 people in Ontario who are morbidly obese. This would correspond to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake). However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective).
Conclusion
As per the GRADE Working Group, overall recommendations consider 4 main factors.
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome.
The quality of the evidence.
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise.
Uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 shows the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For GP, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality, consistency and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $107,000 Cdn to $1.6M Cdn for the device cost alone, while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high-quality studies of effectiveness. Further evidence of effectiveness should be available in the future since there is a RCT underway that is examining the use of GES in patients with severe refractory GP associated with diabetes and idiopathic etiologies (ClinicalTrials.gov identifier NCT00157755).
For morbid obesity, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and consistency), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake) while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high quality studies of effectiveness. However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective).
Overall GRADE and Strength of Recommendation (Including Uncertainty)
PMCID: PMC3413096  PMID: 23074486
18.  Revisional Laparoscopic Gastric Pouch Resizing for Inadequate Weight Loss After Roux-en-Y Gastric Bypass 
Obesity Surgery  2015;25(7):1103-1108.
Background
Weight regain due to gastric pouch dilatation after Roux-en-Y gastric bypass (RYGB) is seen more frequently after long-term follow-up. We studied the feasibility and safety of laparoscopic pouch resizing (LPR) for dilated gastric pouch after RYGB associated with inadequate weight loss.
Methods
From 1st June 2011 to 1st September 2013, patients who underwent LPR after failed RYGB were retrospectively compared and analyzed. Data included patient demographics, comorbidity, indication for revision, preoperative weight and BMI, operative time, hospital stay, conversion rate, mean follow-up, body mass index (BMI) loss, percentage excess weight loss (%EWL), reoperation rate, morbidity, and mortality.
Results
Out of 170 revisional bariatric procedures, 32 LPR (27/5, F/M) were performed for dilated gastric pouch after RYGB. The mean age, preoperative weight, and BMI were 38.3 ± 9.3 years, 101.7 ± 22.8 kg, 38.8 ± 6.4 kg/m2, respectively. The median operative time and hospital stay were 100 min and 2 days, respectively. All pouch resizing procedures were carried out laparoscopically, with none requiring conversion to open surgery. The overall complication and reoperation rates were 15.6 and 3.1 %, respectively. There were no deaths. The mean follow-up was 14.1 ± 6.2 months. The mean postoperative BMI was 32.8 ± 7.3 kg/m2, and the median %EWL was 29.1 %.
Conclusions
LPR is safe and can lead to adequate weight loss. However, long-term follow-up is needed to determine the efficiency and durability of this procedure.
doi:10.1007/s11695-015-1579-9
PMCID: PMC4460267  PMID: 25599857
Laparoscopy; Gastric pouch reduction; Gastric bypass; Revisional
19.  Longitudinal plication - a surgical strategy for complete rectal prolapse management 
BMC Surgery  2014;14:17.
Background
Rectal prolapse is a known problem since antiquity and the cause is not fully understood. Despite the presence of more than 100 lines of treatment, none of them is ideal.
Methods
Between the years of (2005–2011), thirty patients with full-thickness rectal prolapse were operated upon. Age ranged between (2–65 years) with a mean of 21.5 year. Male to female ratio was (2:1). Each prolapsed rectum was repaired with longitudinal plication (LP) at two or three points accordingly using braded polyglycolic acid – absorbable 1.0 suture material. Plications started by inserting a stitch at the most proximal part of the prolapse, followed by successive similar transverse stiches continuing in a spiral fashion till the mucocutaneous junction. We used three LP in adults and two in children. All of the patients where operated upon as a day-case procedure and discharged 6 hours after the operation.
Results
In this series of patients, twenty-nine of them had complete recovery from the prolapse. Only one patient had recurrence 2 years after the operation, and the same procedure was applied successfully with uneventful post-operative period. Although twenty-three patients had fecal Incontinence, twenty-one of them regained continence after operation.
Conclusions
This method is an easy perineal procedure, with fewer complications. It can be performed for all age groups, in an ordinary surgical unit, by an expert anorectal surgeon. We found that our procedure is simple, safe and less invasive.
doi:10.1186/1471-2482-14-17
PMCID: PMC3994363  PMID: 24655367
Fecal incontinence; Procidentia; Circumferential protrusion; Rectal wall; Anal sphincter complex
20.  Laparoscopic Gastric Plication: An Emerging Bariatric Procedure with High Surgical Revision Rate 
Introduction: Laparoscopic gastric plication (LGCP) reduces gastric volume without resecting or implanting a foreign body. Although still considered investigational, it could be appropriate for young patients with a low body mass index (BMI) and for those unwilling to undergo sleeve gastrectomy, gastric banding, or bypass.
Objectives: The aim of this study was to assess the mid-term results (2 years) of LGCP in terms of safety and efficacy.
Methods: A total of 56 obese patients (47 female; mean age=30.5±11.7 years; mean BMI=40.31±4.7 kg/m2) were candidates for LGCP from January 2011 to October 2013. Early and late complications, BMI, and excess BMI loss (EBL) were prospectively recorded at 3, 6, 9, 12, 18, and 24 months follow-up.
Results: Mean operative time was 72.4±15.6 minutes. No conversion was required. Mean hospital stay was 3 days. Mean %EBL was 34.3±18.40%, 40.1±24.5%, 47.4±30.2%, 46.5±34.6%, 47.8±43.2%, and 55.3±53.6% at 3, 6, 9, 12, 18, and 24 months, respectively. The overall complication rate was 32.14%. Perioperative mortality was zero. Surgical revision was needed in 30 patients: 12 for unsatisfactory weight loss and 18 for gastric prolapse (one acute within 30 days), respectively.
Conclusion: LGCP showed high complication rates requiring surgical revision.
doi:10.1089/bari.2015.0002
PMCID: PMC4575507  PMID: 26421246
21.  Off-pump anteroapical aneurysm plication following left ventricular postinfarction aneurysm: effect on cardiac function, clinical status and survival 
Canadian Journal of Surgery  2013;56(2):119-127.
Background
In patients with coronary disease and aneurysm, ventricular reconstruction with revascularization is a surgical option. Details of patient selection and optimal surgical technique are still debated. We report our results with off-pump aneurysm plication after ventricular aneurysm with relative wall thinning.
Methods
We retrospectively reviewed the records of 248 patients who had an operation for postinfarction left ventricular aneurysm. Reconstruction was accomplished by off-pump anteroapical aneurysm plication. The following variables were recorded: preoperative clinical, angiographic and echocardiographic findings and operative procedures. Outcomes were early mortality, long-term survival and poor 5-year result, defined as the need for transplantation or repeated hospitalization for congestive heart failure. Risk factors were pinpointed using the t test and survival curves. Independent risk factors were identified using Cox regression methods.
Results
Hospital mortality was low (2.0%). Mean follow-up was 5.8 (standard deviation [SD] 3.8) years. Actuarial survival at 1 and 5 years was 94% and 84%. Among the 232 survivors, 200 were in functional class I or II, and the average increase in ejection fraction was 14.0% (SD 3.1%). As determined by multivariable analysis, factors predicting poor outcome were advanced age, ejection fraction less than 0.35, conicity index less than 1, end-systolic volume index greater than 80 mL/m2, advanced New York Heart Association functional class and congestive heart failure.
Conclusion
Using wall thinning as a criterion for patient selection, the technique of off-pump anteroapical aneurysm plication can be performed with low operative mortality and provides good symptomatic relief and long-term survival.
doi:10.1503/cjs.022111
PMCID: PMC3617117  PMID: 23351499
22.  Study protocol of the DUCATI-study: a randomized controlled trial investigating the optimal common channel length in laparoscopic gastric bypass for morbid obese patients 
BMC obesity  2015;2:28.
Background
Morbid obesity has become one of the most frequent chronic medical disorders in Western countries, affecting 1.5-2 % of the Dutch population. Currently, the laparoscopic Roux-Y gastric bypass is considered to be the most effective bariatric treatment option for morbid obesity as it results in adequate weight loss and a significant decrease in comorbidity. Although this technique has been applied for years, the optimal lengths of the three bowel limbs (alimentary limb, biliopancreatic limb, and common channel) in order to achieve maximal percentage excess weight loss with minimal side effects (i.e. malabsorption symptoms), are unknown. As ‘normal’ sized gastric bypasses achieve an average of 60 − 80 % excess weight loss after one year, one could hypothesize that afferent limb lengths should be longer in order to reduce the common channel length, thereby improving outcome in terms of excess weight loss.
The aim of the current study is to investigate the effect of the length of the common channel in gastric bypass surgery for morbid obesity. In this randomized controlled trial the very long Roux limb gastric bypass will be compared to the standard gastric bypass, in order to conclude which option is the optimal therapeutic strategy in the morbidly obese patient.
Methods/design
In this multicentre trial patients will be randomized either to a very long Roux limb gastric bypass with a fixed common channel length of 100 cm, or to a standard gastric bypass with a variable common channel length.
The primary objective is to evaluate whether the very long Roux limb gastric bypass is superior in terms of percentage excess weight loss after one year follow-up compared to the standard gastric bypass.
Secondary endpoints are quality-of-life, cure /improvement of obesity related comorbidity, complications, malnutrition, re-admission rate, and re-operation rate.
Discussion
We hypothesize that our proposed distal LRYGB will provide for improved results concerning % EWL with an acceptable rate of (metabolic) complications.
Our main point of interest is to determine if the distal LRYGB is a superior alternative to standard LRYGB in terms of percentage excess weight loss and to put more focus on the role of the common channel. Therefore we will perform this randomized controlled trial comparing both techniques, with % EWL as a primary outcome.
Trial registration
CCMO registration number: NL43951.101.13 and Netherlands Trial Registry number: NTR4466.
doi:10.1186/s40608-015-0059-z
PMCID: PMC4511552  PMID: 26217543
Morbid obesity; Bariatric surgery; Laparoscopic Roux -Y gastric bypass; Common channel
23.  Variations of Weight Loss Following Gastric Bypass and Gastric Band 
Annals of surgery  2008;248(2):233-242.
Objective
To compare and describe the weight loss outcomes from gastric bypass and gastric band so as to define the variation of excess weight loss (EWL) among individual patients, the time to onset of effect, and the durability of weight loss in severely obese adults.
Summary Background Data
Gastric bypass and gastric band are the most common operations for obesity performed in the United States, but few reports have compared these 2 procedures.
Methods
Patients (N = 1733, aged 18–65 years) met National Institutes of Health criteria for obesity surgery and underwent either gastric bypass or gastric band between March 1997 and November 2006. The selection of bypass versus band was based on patient/surgeon discussion. The evaluable sample consisted of 1518 patients. The percentage of EWL was assessed over 2 years. Successful weight loss was defined a priori as ≥40% EWL in each of four 6-month postoperative measurement periods. The analyses included a mixed model and generalized estimating equation (GEE) model with repeated measures. Odds ratios and descriptive analyses were also provided.
Results
Gastric bypass was associated with less individual variation in weight loss than gastric band. Both procedures were associated with a significant EWL benefit (Treatment Group effect P < 0.0001), but they differed in terms of time to effect (Treatment Group × Period interaction effect P < 0.0001). The mean EWL for gastric bypass was greater at each measurement period (6, 12, 18, 24 months) compared with gastric band (P < 0.0001). Furthermore, at each of the postoperative measurement periods within each treatment group (bypass and band), the mean EWL was greater for those who had preoperative body mass index (BMI) ≤50 kg/m2 than for those who had preoperative BMI >50 kg/m2 (P < 0.0001). Gastric bypass was consistently associated with a greater likelihood of at least a 40% EWL in each of the 6-month postoperative measurement periods (GEE, P < 0.0001). The odds ratio estimates at months 6, 12, 18, and 24 were 18.2, 20.6, 15.5, and 9.1, respectively. Despite these clinically meaningful outcome differences, nearly all (≥93%) bypass and band patients who had ≥40% EWL at 6, 12, or 18 months postoperatively maintained at least this level of success at 2 years.
Conclusions
Gastric bypass produced more rapid, greater, and more consistent EWL across individuals over a 2-year postoperative period than gastric band.
doi:10.1097/SLA.0b013e3181820cbc
PMCID: PMC4908312  PMID: 18650633
24.  Efficacy of endoluminal gastroplication in Japanese patients with proton pump inhibitor-resistant, non-erosive esophagitis 
AIM: To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication (ELGP) in patients with proton pump inhibitor (PPI)-resistant, non-erosive reflux disease (NERD).
METHODS: The subjects were NERD patients, diagnosed by upper endoscopy before PPI use, who had symptoms such as heartburn or reflux sensations two or more times a week even after 8 wk of full-dose PPI treatment. Prior to ELGP, while continuing full-dose PPI medication, patients’ symptoms and quality of life (QOL) were assessed using the questionnaire for the diagnosis of reflux disease, the frequency scale for symptoms of gastro-esophageal reflux disease (FSSG), gastrointestinal symptoms rating scale, a 36-item short-form. In addition, 24-h esophageal pH monitoring or 24-h intraesophageal pH/impedance (MII-pH) monitoring was performed. The Bard EndoCinchTM was used for ELGP, and 2 or 3 plications were made. After ELGP, all acid reducers were temporarily discontinued, and medication was resumed depending on the development and severity of symptoms. Three mo after ELGP, symptoms, QOL, pH or MII-pH monitoring, number of plications, and PPI medication were evaluated. Further, symptoms, number of plications, and PPI medication were evaluated 12 mo after ELGP to investigate long-term effects.
RESULTS: The mean FSSG score decreased significantly from before ELGP to 3 and 12 mo after ELGP (19.1 ± 10.5 to 10.3 ± 7.4 and 9.3 ± 9.9, P < 0.05, respectively). The total number of plications decreased gradually at 3 and 12 mo after ELGP (2.4 ± 0.8 to 1.2 ± 0.8 and 0.8 ± 1.0, P < 0.05, respectively). The FSSG scores in cases with no remaining plications and in cases with one or more remaining plications were 4.4 and 2.7, respectively, after 3 mo, and 2.0 and 2.8, respectively, after 12 mo, showing no correlation to plication loss. On pH monitoring, there was no difference in the percent time pH < 4 from before ELGP to 3 mo after. Impedance monitoring revealed no changes in the number of reflux episodes or the symptom index for reflux events from before ELGP to 3 mo after, but the symptom sensitivity index decreased significantly 3 mo after ELGP (16.1 ± 12.9 to 3.9 ± 8.3, P < 0.01). At 3 mo after ELGP, 6 patients (31.6%) had reduced their PPI medication by 50% or more, and 11 patients (57.9%) were able to discontinue PPI medication altogether. After 12 mo, 3 patients (16.7%) were able to reduce the amount of PPI medication by 50% or more, and 12 patients (66.7%) were able to discontinue PPI medication altogether. A high percentage of cases with remaining plications had discontinued PPIs medication after 3 mo, but there was no difference after 12 mo. No serious complications were observed in this study.
CONCLUSION: ELGP was safe, resulted in significant improvement in subjective symptoms, and allowed less medication to be used over the long term in patients with PPI-refractory NERD.
doi:10.3748/wjg.v18.i41.5940
PMCID: PMC3491602  PMID: 23139611
Endoluminal gastroplication; Esophageal pH; Gastro-esophageal reflux disease; Non-erosive reflux disease; Proton pump inhibitor-resistant
25.  Banded gastric bypass - four years follow up in a prospective multicenter analysis 
BMC Surgery  2014;14:88.
Background
The gastric bypass is the gold standard of bariatric surgery. Nevertheless some patients show insufficient weight loss or weight regain. Dilation of the pouch or the pouch outlet may be the cause. The banded gastric bypass tries to overcome dilation by placing an implant around the pouch or pouch outlet. In this study we describe our results using the GaBP™ ring system in banded gastric bypass operations in 3 bariatric centers.
Methods
183 patients in 3 bariatric reference centers received a banded gastric bypass operation using the GaBP™ ring system. Up to 4 years follow up was evaluated including weight loss and complications.
Results
Mean EWL after 6 Months was 60% with a mean BMI of 30.1 kg/m2. After one year mean EWL reached 75.3% with a mean BMI of 27 kg/m2 (110 patients). After two and three years the EWL was 78.8% (n = 49) and 79.9% (n = 35). There was a mean EWL of 85% after 4 years. Thirteen patients finished a 4 year follow up period and mean BMI after 4 years was 25.2 kg/m2. In the perioperative and early postoperative period there was a low complication rate (4.3%). Stenosis or dysphagia was observed in only one patient. There was only one ring related complication.
Conclusion
Banded gastric bypass using the GaBP™ ring system allows good weight loss with no regain of weight in a four year follow up. The complication rate is low. A randomized controlled trial is currently underway to compare banded and conventional gastric bypass.
doi:10.1186/1471-2482-14-88
PMCID: PMC4236457  PMID: 25391401
Gastric bypass; Banded gastric bypass; Restriction; Gastric banding; Bariatric surgery

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