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1.  Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study) 
BMC Surgery  2014;14:58.
Background
Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure.
Methods/Design
In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.
Discussion
The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia.
Trail registration number
NCT01927497 (Clinicaltrial.gov).
doi:10.1186/1471-2482-14-58
PMCID: PMC4158342  PMID: 25163547
Abdominoperineal resection; Rectal cancer; Radiotherapy; Primary perineal wound closure; Biological mesh; perineal wound infection; Perineal wound healing
2.  Results of the introduction of a minimally invasive esophagectomy program in a tertiary referral center 
Journal of Thoracic Disease  2012;4(5):467-473.
Background
Esophagectomy is accompanied by a high postoperative complication rate. Minimally invasive esophageal surgery appears to be a promising technique that might be associated with a lower pulmonary morbidity rate. The objective of this study was to describe the implementation of minimally invasive esophageal surgery in a tertiary referral center and to compare the results of our first series of minimally invasive esophagectomies (MIE) to conventional open esophagectomies.
Methods
MIE was implemented after several procedures had been proctored by a surgeon with extensive experience with MIE. Preoperative characteristics and the postoperative course of patients who underwent a transthoracic esophagectomy were prospectively registered. Morbidity and overall hospital stay were compared between minimally invasive and open resections performed in the same period.
Results
A total of 90 consecutive esophageal cancer patients underwent a transthoracic resection, 41 patients by means of a minimally invasive approach. Preoperative characteristics were comparable for both groups. The duration of surgery was longer in the MIE group (6.0 vs. 5.2 hours, P<0.001) and median blood loss was lower [100 vs. 500 mL (P<0.001)]. There was only a trend towards a shorter hospital stay in the MIE group (11 vs. 13 days, P=0.072), pulmonary complications occurred in 20% of patients in the MIE group vs. 31% in the open group (P=0.229). The overall complication rate was 51% in the MIE group vs. 63% in the open group, P=0.249.
Conclusions
Implementation of MIE in our center was successful and it appears to be a safe technique for patients with potentially curable esophageal carcinoma.
doi:10.3978/j.issn.2072-1439.2012.09.05
PMCID: PMC3461068  PMID: 23050110
Esophageal cancer; surgical technical; complications; thoracoscopy
3.  A multidisciplinary evidence-based guideline for minimally invasive surgery. 
Gynecological Surgery  2012;9(3):271-282.
The Dutch Society for Endoscopic Surgery together with the Dutch Society of Obstetrics and Gynecology initiated a multidisciplinary working group to develop a guideline on minimally invasive surgery to formulate multidisciplinary agreements for minimally invasive surgery aiming towards better patient care and safety. The guideline development group consisted of general surgeons, gynecologists, an anesthesiologist, and urologist authorized by their scientific professional association. Two advisors in evidence-based guideline development supported the group. The guideline was developed using the “Appraisal of Guidelines for Research and Evaluation” instrument. Clinically important aspects were identified and discussed. The best available evidence on these aspects was gathered by systematic review. Recommendations for clinical practice were formulated based on the evidence and a consensus of expert opinion. The guideline was externally reviewed by members of the participating scientific associations and their feedback was integrated. Identified important topics were: laparoscopic entry techniques, intra-abdominal pressure, trocar use, electrosurgical techniques, prevention of trocar site herniation, patient positioning, anesthesiology, perioperative care, patient information, multidisciplinary user consultation, and complication registration. The text of each topic contains an introduction with an explanation of the problem and a summary of the current literature. Each topic was discussed, considerations were evaluated and recommendations were formulated. The development of a guideline on a multidisciplinary level facilitated a broad and rich discussion, which resulted in a very complete and implementable guideline.
doi:10.1007/s10397-012-0731-y
PMCID: PMC3401300  PMID: 22837735
Guideline; Minimally invasive surgery; Multidisciplinary; Laparoscopy; Access; Entry; Pneumoperitoneum
4.  Less adhesiolysis and hernia repair during completion proctocolectomy after laparoscopic emergency colectomy for ulcerative colitis 
Surgical Endoscopy  2011;26(2):368-373.
Background
The aim of this study was to determine whether the need for adhesiolysis during completion proctectomy (CP) with ileopouch anal anastomosis (IPAA) is influenced by the surgical approach of the initial emergency colectomy for ulcerative colitis and the hospital setting.
Methods
One hundred consecutive patients who underwent CP with IPAA in our center between January 1999 and April 2010 were included. Emergency colectomy had been performed laparoscopically in 30 of 52 patients at the Academic Medical Center Amsterdam and in 6 of 48 patients at referring hospitals. Case files of these patients were retrospectively reviewed.
Results
Significantly more extensive adhesiolysis was performed after open compared to laparoscopic colectomy (47 vs. 6%, P < 0.001). In univariate analysis, emergency colectomy at a referring hospital was also predictive for adhesiolysis (P = 0.003), but the open approach for the initial colectomy was the only independent predictive factor for the need for adhesiolysis (P < 0.001) in a multivariable ordinal logistic regression analysis. Operating time of CP was significantly longer when limited [18 (95% CI = 0–36) min] or extensive [55 (35–75) min] adhesiolysis had to be performed. The interval to CP was longer after open colectomy and after colectomy performed at a referring hospital. Significantly more incisional hernia corrections during CP were performed after open emergency colectomy (14 vs. 0%, P = 0.024). Overall morbidity and postoperative hospital stay of CP were not related to the surgical approach or the hospital setting of the emergency colectomy.
Conclusion
Laparoscopic as opposed to open emergency colectomy is associated with less adhesiolysis, fewer incisional hernias, and a shorter interval to completion proctectomy.
doi:10.1007/s00464-011-1880-1
PMCID: PMC3261391  PMID: 21993930
Restorative proctocolectomy; Ulcerative colitis; Abdominal adhesions; Laparoscopy; Incisional hernia
5.  Alternative specimen extraction techniques after laparoscopic emergency colectomy in inflammatory bowel disease 
Surgical Endoscopy  2011;26(2):408-412.
Background
Omitting the extraction site incision potentially further decreases the abdominal wall trauma in laparoscopic surgery. The purpose of this study was to report the results of alternative specimen extraction techniques after laparoscopic emergency colectomy in patients with inflammatory bowel disease (IBD).
Methods
Ten consecutive patients with IBD underwent (sub)acute emergency colectomy for refractory disease from October 2009 until December 2010. The specimen was retrieved via the stoma site in three and transrectally in seven patients. Patient data were prospectively collected. In case of later completion proctectomy and pouch procedure, adhesions were systematically scored.
Results
The extraction techniques were all feasible. Median operative time was 219 (interquartile range (IQR), 197–232) min. The pain scores and morphine requirement in patients decreased quickly after surgery. No infectious complications occurred. In five patients, a completion proctectomy was performed at a median time of 7 (IQR, 3.8–9.3) months after colectomy. All patients showed absence of any adhesions in the pelvis. In two patients, limited adhesions of the cut side of the mesentery were present.
Conclusions
Specimen extraction via the rectum or stoma site is a safe, alternative way to extract the specimen after laparoscopic colectomy. No infectious complications were observed postoperatively and no pelvic adhesions were found during completion proctectomy.
doi:10.1007/s00464-011-1888-6
PMCID: PMC3261408  PMID: 21909858
Colitis; Inflammatory bowel disease; Colectomy; Laparoscopy; Extraction
6.  Morbidity related to defunctioning ileostomy closure after ileal pouch-anal anastomosis and low colonic anastomosis 
Purpose
Defunctioning ileostomies are widely performed in order to prevent or treat anastomotic leakage after colorectal surgery. The aim of the present study was to determine morbidity related to stoma closure and to identify predictive factors of a complicated postoperative course.
Methods
A consecutive series of 138 patients were retrospectively analyzed after stoma reversal. Data collection included general demographics and surgery-related aspects. Morbidity related to stoma closure was retrieved from our prospectively collected registry of complications.
Results
In 74 of 138 patients, defunctioning ileostomy was performed after restorative proctocolectomy and ileal pouch-anal anastomosis (IPAA). The remaining ileostomies (n = 64) were constructed after a low colorectal or coloanal anastomosis. A total of 46 complications were recorded in 28 patients resulting in an overall complication rate of 20.3%. Anastomotic leakage rate was 4.3%, and reoperation rate was 8.0%. The number of complications according to the Clavien–Dindo classification was 5 for grade I (10.9%), 26 for grade II (56.5%), 13 for grade III (28.3%), 1 for grade IV (2.2%), and 1 for grade V (2.2%). Multivariate analysis revealed a significantly higher ASA score in the complicated group (P = 0.015, odds ratio 2.6, 95% confidence interval 1.2–5.6).
Conclusions
Closure of a defunctioning ileostomy is associated with 20% morbidity and a reoperation rate of 8%. There is an urgent need for criteria on which a more selective use of a defunctioning ileostomy after low colonic anastomosis or IPAA can be based given its associated morbidity.
doi:10.1007/s00384-011-1276-7
PMCID: PMC3249166  PMID: 21761119
Defunctioning ileostomy; Stoma; Ileostomy; Morbidity
7.  Quality of life after laparoscopic and open colorectal surgery: A systematic review 
This study was a systematic review of the available evidence on quality of life in patients after laparoscopic or open colorectal surgery. A systematic review was performed of all randomized clinical trials (RCTs) that compared laparoscopic with open colorectal surgery. Study selection, quality assessment and data extraction were carried out independently by two reviewers. Primary endpoint was quality of life after laparoscopic and open colorectal surgery, as assessed by validated questionnaires. The search resulted in nine RCTs that included 2263 patients. Short- and long-term results of these RCTs were described in 13 articles. Postoperative follow-up ranged from 2 d to 6.7 years. Due to clinical heterogeneity, no meta-analysis could be conducted. Four RCTs did not show any difference in quality of life between laparoscopic or open colorectal surgery. The remaining five studies reported a better quality of life in favor of the laparoscopic group on a few quality of life scales at time points ranging from 1 wk to 2 years after surgery. In conclusion, based on presently available high-level evidence, this systematic review showed no clinically relevant differences in postoperative quality of life between laparoscopic and open colorectal surgery.
doi:10.3748/wjg.v16.i40.5035
PMCID: PMC2965279  PMID: 20976839
Quality of life; Colorectal surgery; Laparoscopy; Colonic neoplasms; Colonic diseases; Inflammatory bowel diseases
8.  The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037) 
BMC Surgery  2010;10:29.
Background
Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.
The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis).
Methods/Design
In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs.
Discussion
The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis.
Trial registration
Nederlands Trial Register NTR2037
doi:10.1186/1471-2482-10-29
PMCID: PMC2974662  PMID: 20955571
9.  Hybrid NOTES transgastric cholecystectomy with reliable gastric closure: an animal survival study 
Surgical Endoscopy  2010;25(3):728-736.
Background
Secure transluminal closure remains the most fundamental barrier to safe translation of transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures to humans. Obtaining optimal critical view of safety (CVS) is a prerequisite to performing cholecystectomy avoiding common bile duct injury.
Objectives
(1) To evaluate feasibility and safety of hybrid transgastric NOTES cholecystectomy. (2) To evaluate feasibility and reliability of gastrotomy closure using a novel Over-The-Scope-Clip (OTSC; Ovesco) in survival porcine experiments.
Methods
Laparoscopic access to the abdominal cavity was obtained by two 2-mm and one umbilical optical trocar(s). Gastric access was created by balloon dilatation of a needle knife puncture up to 18 mm. Exposure of CVS was obtained and evaluated by aid of a 2-mm device. Subsequently the cystic duct and artery were clipped endoscopically. After laparoscopic dissection the specimen was extracted via the stomach. The gastrotomy was closed endoscopically using the OTSC. Necropsy was performed after 10 days with inspection of gastrotomy and peritoneal cavity for complications. Experiments were planned in 3 acute and 16 survival pigs. Main outcome parameters were documented exposure of CVS, successful cholecystectomy and closure, uncomplicated survival and histology-confirmed full-thickness closure.
Results
In all 16 survival experiments CVS was obtained satisfactorily and hybrid cholecystectomy was successfully performed [100%; 95% confidence interval (CI): 81–100%]. Transgastric closure was endoscopically successful in all experiments in mean time of 7 min [standard deviation (SD) 3 min]. At necropsy 10 days after surgery there were no signs of (infectious) complications. Histology confirmed full-thickness healing with 100% success (95% CI: 81–100%).
Conclusion
Hybrid transgastric NOTES cholecystectomy is feasible, safe and results in optimal CVS. Use of OTSC for gastrotomy closure is feasible, reliable and results in histology-proven full-thickness closure in survival porcine experiments.
Electronic supplementary material
The online version of this article (doi:10.1007/s00464-010-1242-4) contains supplementary material, which is available to authorized users.
doi:10.1007/s00464-010-1242-4
PMCID: PMC3044824  PMID: 20721586
Therapeutic/palliation, endoscopy; G-I, endoscopy; Surgical, technical; Instruments, technical; Cholecystectomy; Digestive; Gastrointestinal perforations; Endoscopic closure; Critical view of safety
11.  Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial 
World Journal of Surgery  2009;33(7):1368-1373.
Background
Laparoscopic surgery has become popular during the last decade, mainly because it is associated with fewer postoperative complications than the conventional open approach. It remains unclear, however, if this benefit is observed after laparoscopic correction of perforated peptic ulcer (PPU). The goal of the present study was to evaluate whether laparoscopic closure of a PPU is as safe as conventional open correction.
Methods
The study was based on a randomized controlled trial in which nine medical centers from the Netherlands participated. A total of 109 patients with symptoms of PPU and evidence of air under the diaphragm were scheduled to receive a PPU repair. After exclusion of 8 patients during the operation, outcomes were analyzed for laparotomy (n = 49) and for the laparoscopic procedure (n = 52).
Results
Operating time in the laparoscopy group was significantly longer than in the open group (75 min versus 50 min). Differences regarding postoperative dosage of opiates and the visual analog scale (VAS) for pain scoring system were in favor of the laparoscopic procedure. The VAS score on postoperative days 1, 3, and 7 was significant lower (P < 0.05) in the laparoscopic group. Complications were equally distributed. Hospital stay was also comparable: 6.5 days in the laparoscopic group versus 8.0 days in the open group (P = 0.235).
Conclusions
Laparoscopic repair of PPU is a safe procedure compared with open repair. The results considering postoperative pain favor the laparoscopic procedure.
doi:10.1007/s00268-009-0054-y
PMCID: PMC2691927  PMID: 19430829
12.  Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study) 
BMC Surgery  2009;9:4.
Background
Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.
The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.
Methods/design
Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment.
Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures.
Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group.
Discussion
The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas.
Trial registration number
(trialregister.nl) NTR1422
doi:10.1186/1471-2482-9-4
PMCID: PMC2664790  PMID: 19284647
13.  Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial) 
BMC Surgery  2008;8:15.
Background
With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction.
The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs.
Methods/design
The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007.
Discussion
The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the best treatment for recurrent distal ileitis in Crohn's disease.
Trial registration
Nederlands Trial Register NTR1150
doi:10.1186/1471-2482-8-15
PMCID: PMC2533646  PMID: 18721465
14.  Long-Term Surgical Recurrence, Morbidity, Quality of Life, and Body Image of Laparoscopic-Assisted vs. Open Ileocolic Resection for Crohn’s Disease: A Comparative Study 
Diseases of the Colon and Rectum  2008;51(6):858-867.
Purpose
Several studies have compared conventional open ileocolic resection with a laparoscopic-assisted approach. However, long-term outcome after laparoscopic-assisted ileocolic resection remains to be determined. This study was designed to compare long-term results of surgical recurrence, quality of life, body image, and cosmesis in patients who underwent laparoscopic-assisted or open ileocolic resection for Crohn’s disease.
Methods
Seventy-eight consecutive patients who underwent ileocolic resection during the period 1995 to 1998 were analyzed; 48 underwent a conventional open approach in the Academic Medical Centre (Amsterdam, The Netherlands) and 30 underwent a laparoscopic-assisted approach in the Leiden University Medical Centre (Leiden, The Netherlands). Primary outcome parameters were reoperation and readmission rate. Secondary outcome parameters were quality of life, body image, and cosmesis.
Results
The two groups were comparable for characteristics of sex, age, and immunosuppressive therapy. Seventy-one patients had a complete follow-up of median 8.5 years. Resection for recurrent Crohn’s disease was performed in 6 of 27 (22 percent) and 10 of 44 (23 percent) patients in the laparoscopic and open groups, respectively. Reoperations for incisional hernia were only performed after conventional open ileocolic resection (3/44 = 6.8 percent). Quality of life and body image were comparable, but cosmesis scores were significantly higher in the laparoscopic group.
Conclusions
Despite small numbers, we found that surgical recurrence and quality of life after laparoscopic-assisted and open ileocolic resection were comparable. Incisional hernias occurred only after open ileocolic resection, and laparoscopic-assisted ileocolic resection resulted in a significantly better cosmesis.
doi:10.1007/s10350-008-9195-6
PMCID: PMC2440934  PMID: 18266036
Crohn’s disease; Laparoscopy; Ileocolic resection; Laparoscopic; CD; Long-term morbidity; Body image; Quality of life
15.  The Anal Fistula Plug versus the mucosal advancement flap for the treatment of Anorectal Fistula (PLUG trial) 
BMC Surgery  2008;8:11.
Background
Low transsphincteric fistulas less than 1/3 of the sphincter complex are easy to treat by fistulotomy with a high success rate. High transsphincteric fistulas remain a surgical challenge. Various surgical procedures are available, but recurrence rates of these techniques are disappointingly high. The mucosal flap advancement is considered the gold standard for the treatment of high perianal fistula of cryptoglandular origin by most colorectal surgeons. In the literature a recurrence rate between 0 and 63% is reported for the mucosal flap advancement. Recently Armstrong and colleagues reported on a new biologic anal fistula plug, a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa. Their prospective series of 15 patients with high perianal fistula treated with the anal fistula plug showed promising results.
The anal fistula plug trial is designed to compare the anal fistula plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain, and quality of life.
Methods/design
The PLUG trial is a randomized controlled multicenter trial. Sixty patients with high perianal fistulas of cryptoglandular origin will be randomized to either the fistula plug or the mucosal advancement flap. Study parameters will be anorectal fistula closure-rate, continence, post-operative pain, and quality of life. Patients will be followed-up at two weeks, four weeks, and 16 weeks. At the final follow-up closure rate is determined by clinical examination by a surgeon blinded for the intervention.
Discussion
Before broadly implementing the anal fistula plug results of randomized trials using the plug should be awaited. This randomized controlled trial comparing the anal fistula plug and the mucosal advancement flap should provide evidence regarding the effectiveness of the anal fistula plug in the treatment of high perianal fistulas.
Trial registration
ISRCTN: 97376902
doi:10.1186/1471-2482-8-11
PMCID: PMC2467399  PMID: 18573198
16.  Fibrin glue and transanal rectal advancement flap for high transsphincteric perianal fistulas; is there any advantage? 
Backgrounds and aim
In recent decades, fibrin glue has appeared as an alternative treatment for high perianal fistulas. Early results seemed promising, with high success rates being reported. However, with increasing follow-up, the enthusiasm was tempered because of disappointing results. The aim of this retrospective study was to assess the additional value of fibrin glue in combination with transanal advancement flap, compared to advancement flap alone, for the treatment of high transsphincteric fistulas of cryptoglandular origin.
Materials and methods
Between January 1995 and January 2006, 127 patients were operated for high perianal fistulas with an advancement flap. After exclusion of patients with inflammatory bowel disease or HIV, 80 patients remained. A consecutive series of 26 patients had an advancement flap combined with obliteration of the fistula tract with fibrin glue. Patients were matched for prior fistula surgery, and the advancement was performed identically in all patients. In the fibrin glue group, glue was installed retrogradely in the fistula tract after the advancement was completed and the fistula tract had been curetted.
Results
Minimal follow-up after surgery was 13 months [median of 67 months (range, 13–127)]. The overall recurrence rate was 26% (n = 21). Recurrence rates for advancement flap alone vs the combination with glue were 13% vs 56% (p = 0.014) in the group without previous fistula surgery and 23% vs 41% (p = 0.216) in the group with previous fistula surgery.
Conclusion
Obliterating the fistula tract with fibrin glue was associated with worse outcome after rectal advancement flap for high perianal fistulas.
doi:10.1007/s00384-008-0460-x
PMCID: PMC2386753  PMID: 18322659
Rectal fistula; Surgery; Recurrence; Fibrin glue; Advancement
17.  Total Laparoscopic Restorative Proctocolectomy: Are There Advantages Compared with the Open and Hand-Assisted Approaches? 
Diseases of the Colon and Rectum  2008;51(5):541-548.
Purpose
A randomized, controlled trial comparing hand-assisted laparoscopic restorative proctocolectomy with open surgery did not show an advantage for the laparoscopic approach. The trial was criticized because hand-assisted laparoscopic restorative proctocolectomy was not considered a true laparoscopic proctocolectomy. The objective of the present study was to assess whether total laparoscopic restorative proctocolectomy has advantages over hand-assisted laparoscopic restorative proctocolectomy with respect to early recovery.
Methods
Thirty-five patients underwent total laparoscopic restorative proctocolectomy and were compared to 60 patients from a previously conducted randomized, controlled trial comparing hand-assisted laparoscopic restorative proctocolectomy and open restorative proctocolectomy. End points included operating time, conversion rate, reoperation rate, hospital stay, morbidity, quality of life, and costs. The Medical Outcomes Study Short Form 36 and the Gastrointestinal Quality of Life Index were used to evaluate general and bowel-related quality of life.
Results
Groups were comparable for patient characteristics, such as sex, body mass index, preoperative disease duration, and age. There were neither conversions nor intraoperative complications. Median operating time was longer in the total laparoscopic compared with the hand-assisted laparoscopic group (298 vs. 214 minutes; P < 0.001). Morbidity and reoperation rates in the total laparoscopic, hand-assisted laparoscopic, and open groups were comparable (29 vs. 20 vs. 23 percent and 17 vs.10 vs. 13 percent, respectively). Median hospital-stay was 9 days in the total laparoscopic group compared with 10 days in the hand-assisted laparoscopic group and 11 days in the open group (P = not significant). There were no differences in quality of life and total costs.
Conclusions
There were no significant short-term benefits for total laparoscopic compared with hand-assisted laparoscopic restorative proctocolectomy with respect to early morbidity, operating time, quality of life, costs, and hospital stay.
doi:10.1007/s10350-007-9168-1
PMCID: PMC2365983  PMID: 18301949
Restorative proctocolectomy; Total laparosocpic; Hand-assisted laparoscopic; Ileal pouch-anal-anastomosis; Ulcerative colitis; Familial polyposis coli
18.  The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis 
BMC Surgery  2007;7:16.
Backround
Diverticulosis is a common disease in the western society with an incidence of 33–66%. 10–25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the elderly patient or after one episode in the younger (< 50 years) patient. Open sigmoid resection is still the gold standard, but laparoscopic colon resections seem to have certain advantages over open procedures. On the other hand, a double blind investigation has never been performed. The Sigma-trial is designed to evaluate the presumed advantages of laparoscopic over open sigmoid resections in patients with symptomatic diverticulitis.
Method
Indication for elective resection is one episode of diverticulitis in patients < 50 years and two episodes in patient > 50 years or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits. The diagnosis is confirmed by CT-scan, barium enema and/or coloscopy.
It is required that the participating surgeons have performed at least 15 laparoscopic and open sigmoid resections. Open resection is performed by median laparotomy, laparoscopic resection is approached by 4 or 5 cannula. Sigmoid and colon which contain serosal changes or induration are removed and a tension free anastomosis is created. After completion of either surgical procedure an opaque dressing will be used, covering from 10 cm above the umbilicus to the pubic bone. Surgery details will be kept separate from the patient's notes.
Primary endpoints are the postoperative morbidity and mortality. We divided morbidity in minor (e.g. wound infection), major (e.g. anastomotic leakage) and late (e.g. incisional hernias) complications, data will be collected during hospital stay and after six weeks and six months postoperative. Secondary endpoints are the operative and the postoperative recovery data. Operative data include duration of the operation, blood loss and conversion to laparotomy. Post operative recovery consists of return to normal diet, pain, analgesics, general health (SF-36 questionnaire) and duration of hospital stay.
Discussion
The Sigma-trial is a prospective, multi-center, double-blind, randomized study to define the role of laparoscopic sigmoid resection in patients with symptomatic diverticulitis.
doi:10.1186/1471-2482-7-16
PMCID: PMC1955435  PMID: 17683563
19.  Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study) 
BMC Surgery  2007;7:12.
Background
Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion.
Methods/design
Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics.
Discussion
The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction.
Trial registration
Current Controlled Trials ISRCTN46462267.
doi:10.1186/1471-2482-7-12
PMCID: PMC1925059  PMID: 17608947
20.  Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial) 
BMC Surgery  2006;6:16.
Background
Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay.
The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.
Methods/design
The LAFA-trial is a double blinded, multicenter trial with a 2 × 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a), open colectomy with fast track program (b), laparoscopic colectomy with standard care (c), and laparoscopic surgery with fast track program (d). Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate.
Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36) questionnaire and social functioning can be detected.
Discussion
The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease.
doi:10.1186/1471-2482-6-16
PMCID: PMC1693570  PMID: 17134506
21.  A fatal pseudo-tumour: disseminated basidiobolomycosis 
Background
Basidiobolomycosis is a rare disease caused by the fungus Basidiobolus ranarum, member of the class Zygomycetes, order Entomophthorales, found worldwide. Usually basidiobolomycosis is a subcutaneous infection but rarely gastrointestinal manifestations have been described; 13 adults and 10 children and a few retroperitoneal or pulmonary cases. In gastrointestinal basidiobolomycosis the colon is most frequently involved, usually presenting with subacute mild abdominal pain. In contrast to children only very few described adult patients had hepatic masses. Definitive diagnosis requires culture, serological testing can be helpful. The fungal morphology and the Splendore-Hoeppli phenomenon are characteristic histological features. There are no prominent risk factors. Usually surgery and prolonged antifungal therapy are required.
Case presentation
A 61 year old man presented with progressive left abdominal pain and constipation since a few months. Colonoscopy showed an obstructing tumour in the descending colon, and a hemicolectomy was performed. Histology showed inflammation, possibly caused by a fungal or parasitic infection, without definite identification of an organism. A few weeks postoperatively a CT scan made because of abdominal discomfort, revealed a livermass (6 cm). Treatment with metronidazole, directed against an amoebic liver abscess, was unsuccessful. He developed a marked eosinophilia (27.7%). A liver biopsy was performed and the patient was referred to a university hospital.
A repeated CT scan showed a livermass of 9 cm diameter. Review of colon and liver biopsy samples showed extensive necrosis and histiocytes, multinucleated giant cells and numerous eosinophils. Grocott stained sections contained unusually large hyphae surrounded by strongly eosinophilic material in haematoxylin and eosin stained sections (Splendore-Hoeppli phenomenon). A presumptive diagnosis of Basidiobolus spp. infection was made and treated with amphotericin B (Itraconazol contra-indicated because of renal insufficiency). A few days later the patient died of a septic shock. After autopsy Basidiobolus ranarum was cultured from liver, gallbladder and colon.
Conclusion
Our patient died of gastrointestinal basidiobolomycosis with an obstructing colon tumour and a large hepatic mass. This was a rare presentation of basidiobolomycosis and the second fatal case described worldwide.
doi:10.1186/1471-2334-6-140
PMCID: PMC1574330  PMID: 16978407

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