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1.  Improved access and visibility during stapling of the ultra-low rectum: a comparative human cadaver study between two curved staplers 
Background
The purpose of this study was to compare in human cadavers the applicability of a commonly used stapling device, the CONTOUR® curved cutter (CC) (Ethicon Endo-Surgery, Cincinnati, OH) to a newly released, curved stapler, the Endo GIA™ Radial Reload with Tri-Staple™ Technology (RR) (Covidien, New Haven, CT)
Methods
Four experienced surgeons performed deep pelvic dissection with total mesorectal excision (TME) of the rectum in twelve randomized male cadavers. Both stapling devices were applied to the ultra-low rectum in coronal and sagittal configurations. Extensive measurements were recorded of anatomic landmarks for each cadaver pelvis along with various aspects of access, visibility, and ease of placement for each device.
Results
The RR reached significantly lower into the pelvis in both the coronal and sagittal positions compared to the CC. The median distance from the pelvic floor was 1.0 cm compared to 2.0 cm in the coronal position, and 1.0 cm versus 3.3 cm placed sagitally, p < 0.0001. Surgeons gave a higher visibility rating with less visual impediment in the sagittal plane using the RR Stapler. Impediment of visibility occurred in only 10% (5/48) of RR applications in the coronal position, compared to a rate of 48% (23/48) using the CC, p = 0.0002.
Conclusions
The RR device performed significantly better when compared to the CC stapler in regards to placing the stapler further into the deep pelvis and closer to the pelvic floor, while causing less obstructing of visualization.
doi:10.1186/1750-1164-6-11
PMCID: PMC3539907  PMID: 23148602
2.  Staple Line Failure Using the Proximate® 100 mm Linear Cutter 
Diseases of the Colon and Rectum  2008;51(8):1275-1278.
Purpose
An incomplete linear staple line that was discovered during the stapling of an ileal pouch alerted us to evaluate potential usage concerns with linear cutters. This study was designed to assess the integrity of the staple line of three different sizes of linear staplers.
Methods
In an animal model three different lengths of linear cutters (Proximate®, Ethicon Endo-Surgery) were used to cross-staple and transect the large bowel of one pig to check for the integrity of the proximal end of the staple line.
Results
Cross-stapling and transecting across the pig’s large bowel demonstrated that if the tissue is advanced up to the highest number on the scale of the 100 mm stapling device, insufficient overlap between the proximal end of the staple line and the proximal end of the cut line occur.
Conclusions
Although a more than 100 mm staple line is delivered, the 100 mm cutter may not produce a double-staggered row of staples at the most proximal end of the staple line if the tissue is advanced past the 9.5 cm mark. Ethicon Endo-Surgery has agreed to add indicator markers to the scale label on the instrument to provide the user with additional guidance for tissue placement.
doi:10.1007/s10350-008-9305-5
PMCID: PMC2491405  PMID: 18523825
Linear cutter; Stapler; Anastomotic leakage; Anastomotic insufficiency; Colorectal surgery
3.  Sacro-femoral-pubic angle: a coronal parameter to estimate pelvic tilt 
European Spine Journal  2011;21(4):719-724.
Introduction
Pelvic tilt is an established measure of position which has been tied to sagittal plane spinal deformity. Increased tilt is noted in the setting of the aging spine and sagittal malalignment syndromes such as flatback (compensatory mechanism). However, the femoral heads are often poorly visualized on sagittal films of scoliosis series in adults, limiting the ability to determine pelvic incidence and tilt. There is a need to establish a coronal plane (better visualization) pelvic parameter which correlates closely with pelvic tilt.
Methods
This is a retrospective review of 71 adult patients (47 females and 24 males) with full-length standing spine radiographs. Visualization of all spinal and pelvic landmarks was available coronally and sagittally (including pelvis and acetabuli). Pelvic tilt was calculated through validated digital analysis software (SpineView®). A new parameter, the sacro-femoral-pubic angle (midpoint of S1 endplate to centroid of acetabuli to superior border of the pubic symphysis) was analyzed for correlation (and predictive ability) with sagittal pelvic tilt.
Results
The sacro-femoral-pubic angle (SFP angle) was highly correlated to PT, and according to this analysis, pelvic tilt could be estimated by the formula: PT = 75 − (SFP angle). A Pearson’s correlation coefficient of 0.74 (p < 0.005) and predictive ability of 76% accuracy was obtained (±7.5°). The correlation and predictive ability was greater for males compared to females (male: r = 0.87 and predictive model = 93%; female: r = 0.67 and predictive model = 67%).
Conclusion
The pelvic tilt is an essential measure in the context of radiographic evaluation of spinal deformity and malalignment. Given the routinely excellent visibility of coronal films this study established the SFP as a coronal parameter which can reliably estimate pelvic tilt. The high correlation and predictive ability of the SFP angle should prompt further study and clinical application when lateral radiographs do not permit assessment of pelvic parameters.
doi:10.1007/s00586-011-2061-6
PMCID: PMC3326127  PMID: 22113529
Sagittal alignment; Pelvic tilt; Spine; Coronal; Radiographic evaluation
4.  Risk factors associated with delayed gastric emptying after subtotal gastrectomy with Billroth-I anastomosis using circular stapler for early gastric cancer patients 
Purpose
Gastric surgery may potentiate delayed gastric emptying. Billroth I gastroduodenostomy using a circular stapler is the most preferable reconstruction method. The purpose of this study is to analyze the risk factors associated with delayed gastric emptying after radical subtotal gastrectomy with Billroth I anastomosis using a stapler for early gastric cancer.
Methods
Three hundred and seventy-eight patients who underwent circular stapled Billroth I gastroduodenostomy after subtotal gastrectomy due to early gastric cancer were analyzed retrospectively. One hundred and eighty-two patients had Billroth I anastomosis using a 25 mm diameter circular stapler, and 196 patients had anastomosis with a 28 or 29 mm diameter circular stapler. Clinicopathological features and postoperative outcomes were evaluated and compared between the two groups. Delayed gastric emptying was diagnosed by symptoms and simple abdomen X-ray with or without upper gastrointestinal series or endoscopy.
Results
Postoperative delayed gastric emptying was found in 12 (3.2%) of the 378 patients. Among all the variables, distal margin and circular stapler diameter were significantly different between the cases with delayed gastric emptying and no delayed gastric emptying. There were statistically significant differences in sex, body mass index, comorbidity, complication, and operation type according to circular stapler diameter. In both univariate and multivariate logistic regression analyses, only the stapler diameter was found to be a significant factor affecting delayed gastric emptying (P = 0.040).
Conclusion
In this study, the circular stapler diameter was one of the most significant predictable factors of delayed gastric emptying for Billroth I gastroduodenostomy. The use of a 28 or 29 mm diameter circular stapler rather than a 25 mm diameter stapler in stapled gastroduodenostomy for early gastric cancer can reduce postoperative delayed gastric emptying associated with anastomosic stenosis or edema with relative safety.
doi:10.4174/jkss.2012.83.5.274
PMCID: PMC3491229  PMID: 23166886
Gastric emptying; Gastrectomy; Billroth-I; Gastric neoplasms
5.  The pull-through: back to the future 
Il Giornale di Chirurgia  2013;34(11-12):293-301.
SUMMARY
Background
Historically, coloanal pull-through (P-T) has been the first surgical procedure adopted to facilitate a handmade lower anastomosis. Very popular around mid twentieth century, P-T has had poor diffusion, mainly as a consequence of the technical simplifications brought by staplers. Recent literature seems poor on this specific topic, despite description of P-T appears in published series during the reconstructive phase of total laparoscopic protectomies. A comeback of P-T has also been observed as an option with deferred anastomosis, to allow and protect a coloanal anastomosis in situations at greater risk of dehiscence, avoiding a temporary faecal diversion.
After reviewing the most significant aspects of classic techniques of P-T, we report our experience with transanal laparoscopic P-T for distal rectal cancer, presenting a new, modified P-T with deferred anastomosis aimed at improving defecatory compliance.
Patients and methods
Between January 2008 and June 2011 we operated in 258 rectal cancers (0–14 cm from the anal verge), 62.79% of which by laparoscopic access (VL), with 218 restorative procedures (84.49%). The coloanal anastomoses (CAA) were globally 68 (26.35%), of which 48 in VL procedures (70.58%). In 27 of these CAAs we utilised the P-T procedure, with immediate CAA (I-CAA) in 11 cases (all VL) and delayed CAA (D-CAA) in 16 (2 VL), by selective indications. All CAAs were manually fashioned; 6 D-CAA had the addition of a transverse coloplasty. Site of tumor was the lower rectum in 24 patients, with 21 patients receiving preoperative chemoradiation.
Results
There was no operative mortality. Early morbidity: D-CAA: 3 pelvic abscesses with stoma formation. I-CAA: 1 intraoperative re-resection and coloanal anastomosis with stoma formation for defective distal vascular supply. Late morbidity: anastomotic stenosis in 5/12 I-CAA and 4/14 D-CAA controlled by mechanical dilation. Function: 4/7 D-CAA and 4/6 I-CAA nearly complete functional recovery (Kirwan’s 1 or 2).
Conclusion
There are selective indications to P-T, when resection and anastomosis is not feasible in one step, or also as a primary restorative option in elective cases when a covering stoma is refused or dangerous.
PMCID: PMC3926465  PMID: 24342154
Pull-through; Laparoscopic; Transanal; Rectal cancer; Delayed coloanal anastomosis; Sphincter function
6.  Reconstruction of the esophagojejunostomy by double stapling method using EEA™ OrVil™ in laparoscopic total gastrectomy and proximal gastrectomy 
Here we report the method of anastomosis based on double stapling technique (hereinafter, DST) using a trans-oral anvil delivery system (EEATM OrVilTM) for reconstructing the esophagus and lifted jejunum following laparoscopic total gastrectomy or proximal gastric resection.
As a basic technique, laparoscopic total gastrectomy employed Roux-en-Y reconstruction, laparoscopic proximal gastrectomy employed double tract reconstruction, and end-to-side anastomosis was used for the cut-off stump of the esophagus and lifted jejunum.
We used EEATM OrVilTM as a device that permitted mechanical purse-string suture similarly to conventional EEA, and endo-Surgitie.
After the gastric lymph node dissection, the esophagus was cut off using an automated stapler. EEATM OrVilTM was orally and slowly inserted from the valve tip, and a small hole was created at the tip of the obliquely cut-off stump with scissors to let the valve tip pass through. Yarn was cut to disconnect the anvil from a tube and the anvil head was retained in the esophagus.
The end-Surgitie was inserted at the right subcostal margin, and after the looped-shaped thread was wrapped around the esophageal stump opening, assisting Maryland forceps inserted at the left subcostal and left abdomen were used to grasp the left and right esophageal stump. The surgeon inserted anvil grasping forceps into the right abdomen, and after grasping the esophagus with the forceps, tightened the end Surgitie, thereby completing the purse-string suture on the esophageal stump.
The main unit of the automated stapler was inserted from the cut-off stump of the lifted jejunum, and a trocar was made to pass through. To prevent dropout of the small intestines from the automated stapler, the automated stapler and the lifted jejunum were fastened with silk thread, the abdomen was again inflated, and the lifted jejunum was led into the abdominal cavity.
When it was confirmed that the automated stapler and center rod were made completely linear, the anvil and the main unit were connected with each other and firing was carried out. Then, DST-based anastomosis was completed with no dog-ear.
The method may facilitate safe laparoscopic anastomosis between the esophagus and reconstructed intestine. This is also considered to serve as a useful anastomosis technique for upper levels of the esophagus in laparotomy.
doi:10.1186/1477-7819-9-55
PMCID: PMC3118377  PMID: 21599911
Esophagojejunostomy; Double stapling method; EEA™ OrVil™
7.  Stapled Mucosectomy: An Alternative Technique for the Removal of Retained Rectal Mucosa after Ileal Pouch-Anal Anastomosis 
Gut and Liver  2011;5(4):539-542.
Restorative proctocolectomy (RPC), when performed with a stapled ileal pouch-anal anastomosis (IPAA), allows the retention of the rectal mucosa above the dentate line and can result in disease persistence or recurrence, as well as neoplastic lesions in patients with ulcerative colitis (UC). We report the case of a patient with chronic UC who underwent staple mucosectomy, which is an alternative technique that evolved from stapled hemorrhoidopexy, rather than more traditional procedures. The patient had undergone laparoscopic RPC with a stapled IPAA 2 cm above the dentate line and a temporary loop ileostomy. Because the histopathology showed low-grade dysplasia in the proximal rectum, stapled mucosectomy with a 33-mm circular stapler kit at the time of ileostomy closure was scheduled. Following the application of a purse-string suture 1 cm above the dentate line, the stapler was inserted with its anvil beyond the purse-string and was fired. The excised rectal tissue was checked to ensure that it was a complete cylindrical doughnut. Histopathology of the excised tissue showed chronic inflammation. There were no complications during a follow-up period of 5 months. Because it preserves the normal rectal mucosal architecture and avoids a complex mucosectomy surgery, stapled mucosectomy seems to be a technically feasible and clinically acceptable alternative to the removal of rectal mucosa retained after RPC.
doi:10.5009/gnl.2011.5.4.539
PMCID: PMC3240802  PMID: 22195257
Ulcerative colitis; Retained rectal mucosa; Stapled mucosectomy; Surgical technique
8.  Progression from laparoscopic-assisted to totally laparoscopic distal gastrectomy: comparison of circular stapler (i-DST) and linear stapler (BBT) for intracorporeal anastomosis 
Surgical Endoscopy  2012;27(1):325-332.
Background
Billroth I (B-I) gastroduodenostomy is an anastomotic procedure that is widely performed after gastric resection for distal gastric cancer. A circular stapler often is used for B-I gastroduodenostomy in open and laparoscopic-assisted distal gastrectomy. Recently, totally laparoscopic distal gastrectomy (TLDG) has been considered less invasive than laparoscopic-assisted gastrectomy, and many institutions performing laparoscopic-assisted distal gastrectomy are trying to progress to TLDG without markedly changing the anastomosis method. The purpose of this report is to introduce the technical details of new methods of intracorporeal gastroduodenostomy using either a circular or linear stapler and to evaluate their technical feasibility and safety.
Methods
Seventeen patients who underwent TLDG with the intracorporeal double-stapling technique using a circular stapler (n = 7) or the book-binding technique (BBT) using a linear stapler (n = 10) between February 2010 and April 2011 were enrolled in the study. Clinicopathological data, surgical data, and postoperative outcomes were analyzed.
Results
There were no intraoperative complications or conversions to open surgery in any of the 17 patients. The usual postoperative complications following gastroduodenostomy, such as anastomotic leakage and stenosis, were not observed. Anastomosis took significantly longer to complete with DST (64 ± 24 min) than with BBT (34 ± 7 min), but more stapler cartridges were needed with BBT than with DST.
Conclusions
TLDG using a circular or linear stapler is feasible and safe to perform. DST will enable institutions performing laparoscopic-assisted distal gastrectomy with circular staplers to progress to TLDG without problems, and this progression may be more economical because fewer stapler cartridges are used during surgery. However, if an institution has already been performing δ anastomosis in TLDG but has been experiencing certain issues with δ anastomosis, converting from δ anastomosis to BBT should be beneficial.
Electronic supplementary material
The online version of this article (doi:10.1007/s00464-012-2433-y) contains supplementary material, which is available to authorized users.
doi:10.1007/s00464-012-2433-y
PMCID: PMC3532722  PMID: 22733199
Laparoscopic distal gastrectomy; Totally laparoscopic gastrectomy; Intracorporeal anastomosis; Intracorporeal DST; Book-binding technique
9.  Anterior resection of the rectum--a simplified stapling technique. 
The use of a double stapling technique in anterior resection of the rectum eliminates the necessity for a rectal stump pursestring and removes the problem of tissue pouting on the spindle of the circular EEA stapler when a voluminous rectum is pulled onto it with the pursestring. We have used this technique in 20 patients with tumours in the middle and lower thirds of the rectum without complication. This technique may reduce contamination in the pelvis and certainly shortens operating time. Cost effectiveness of the technique should be evaluated in busy centres where the benefit would appear to be greatest.
PMCID: PMC2499526  PMID: 4051423
10.  Reverse Transrectal Stapling Technique Using the EEA Stapler: An Alternative Approach in Difficult Reversal of Hartmann’s Procedure 
The introduction of circular end-to-end stapling devices (CEEA OR EEA stapler) into colorectal surgery have revolutionised anastomotic techniques. The EEA stapler is generally regarded as an instrument that is safe, reliable, and simple to operate. Despite it’s popularity, very little information is available regarding the technical difficulties encountered during surgery. The routine technique to perform an end-to-end circular colonic anastomosis is to introduce the instrument distally through the anus (transrectal/transanal approach) and attach it to the anvil which is purse stringed at the distal end of the proximal bowel to be anastomosed. Two cases of reversal of Hartmann’s procedure for perforated diverticulitis are described in the present study, where difficulty was experienced while using the EEA stapler in the routine method. Hence, an alternative reverse technique which was used is presented.
doi:10.4103/2006-8808.73618
PMCID: PMC3214281  PMID: 22091338
Colorectal anastomosis; diverticulitis; Hartmann’s procedure; EEA stapler; reverse stapling technique
11.  A New Technique for Laparoscopic Anterior Resection for Rectal Endometriosis 
Background:
Anterior rectal resection is sometimes necessary to treat deeply infiltrating rectovaginal endometriosis. We describe a completely laparoscopic approach as a new way of excising rectal endometriosis that can be used without opening any part of the rectum. This avoids opening the abdomen or any risk of fecal spillage.
Methods:
The patient received preoperative oral bowel preparation. Ureteric stents (6 F) were inserted cystoscopically. The peritoneum in the ovarian fossae was opened lateral to any disease and the rectum reflected off the back of the cervix, leaving any endometriosis on the front of the rectum. The pelvic peritoneum was reflected medially, below the level of the ureters. The mesorectum was then dissected off a 6-cm length of rectum by using a Harmonic scalpel. A circular end-to-end anastomosis instrument was passed anally until the outline of the anvil was visible, inside the colon, above the diseased rectum. The anvil was detached and held by a soft grasper before the rectum was then divided above and below the disease using a laparoscopic stapling device. The tip of the anvil was pushed through the proximal end of the colon allowing reanastomosis of the rectal stump.
Conclusion:
The patient was discharged after 5 days without complications.
PMCID: PMC3015542  PMID: 15791975
Laparoscopy; Colon resection; Endometriosis
12.  The C-seal: A Biofragmentable Drain Protecting the Stapled Colorectal Anastomosis from Leakage 
Colorectal anastomotic leakage (AL) is a serious complication in colorectal surgery leading to high morbidity and mortality rates1. The incidence of AL varies between 2.5 and 20% 2-5. Over the years, many strategies aimed at lowering the incidence of anastomotic leakage have been examined6, 7.
The cause of AL is probably multifactorial. Etiological factors include insufficient arterial blood supply, tension on the anastomosis, hematoma and/or infection at the anastomotic site, and co-morbid factors of the patient as diabetes and atherosclerosis8. Furthermore, some anastomoses may be insufficient from the start due to technical failure.
Currently a new device is developed in our institute aimed at protecting the colorectal anastomosis and lowering the incidence of AL. This so called C-seal is a biofragmentable drain, which is stapled to the anastomosis with the circular stapler. It covers the luminal side of the colorectal anastomosis thereby preventing leakage.
The C-seal is a thin-walled tube-like drain, with an approximate diameter of 4 cm and an approximate length of 25 cm (figure 1). It is a tubular device composed of biodegradable polyurethane. Two flaps with adhesive tape are found at one end of the tube. These flaps are used to attach the C-seal to the anvil of the circular stapler, so that after the anastomosis is made the C-seal can be pulled through the anus. The C-seal remains in situ for at least 10 days. Thereafter it will lose strength and will degrade to be secreted from the body together with the gastrointestinal natural contents.
The C-seal does not prevent the formation of dehiscences. However, it prevents extravasation of faeces into the peritoneal cavity. This means that a gap at the anastomotic site does not lead to leakage.
Currently, a phase II study testing the C-seal in 35 patients undergoing (colo-)rectal resection with stapled anastomosis is recruiting. The C-seal can be used in both open procedures as well as laparoscopic procedures. The C-seal is only applied in stapled anastomoses within 15cm from the anal verge. In the video, application of the C-seal is shown in an open extended sigmoid resection in a patient suffering from diverticular disease with a stenotic colon.
doi:10.3791/2223
PMCID: PMC3157857  PMID: 21085104
13.  Efficacy of the modified anvil grasper for laparoscopic intra-corporeal circular stapled anastomosis 
The traditional anvil grasper may be difficult to use for connecting the stem of an anvil with the centre rod of a circular stapler because the grasper holds the anvil completely still. In addition, the head angle is fixed and cannot handle the anvil head delicately in a tight pelvic space. Many surgeons use a grasper designed for holding the bowel or a dissector for holding the anvil during intra-corporeal circular stapled anastomosis during low anterior resection, sigmoidectomy, left hemi colectomy and know that it is difficult to connect segments with these instruments due to slipping. A new modified anvil grasper was developed with curved blades that can easily grasp the stem of an anvil and smoothly connect it with the centre rod of the circular stapler. This grasper should be useful for surgeons performing laparoscopic intra-corporeal circular stapled anastomoses, which are the most challenging part of laparoscopic colorectal surgery.
doi:10.4103/0972-9941.103132
PMCID: PMC3523458  PMID: 23248448
Anvil grasper; Intra-corporeal circular stapled anastomosis; colorectal cancer
14.  Laparoscopically Assisted Low Anterior Resection for Lower Rectal Endometriosis: Usefulness of Laparoscopic Surgery 
Case Reports in Gastroenterology  2009;3(3):318-323.
A 34-year-old woman presented with pain during menstruation and was diagnosed with endometriosis of the lower rectum. Despite treatment with an LH-RH agonist, she was unable to become pregnant and surgical removal of her endometriosis was recommended. Preoperative magnetic resonance imaging revealed endometriosis localized between the neck of the uterus and rectum with indentation and scuffing. Laparoscopically assisted low anterior resection was performed. Exfoliation was started from the right side of the rectum to the presacral and retrorectal space, and the rectococcygeus ligament was transected. Exfoliation of the retrorectal space was continued to the levator ani muscle and mobilization of the right side of the rectum was performed. In front of the rectum, exfoliation was started posterior to the wall of the vagina, but layers became unclear near the tumor as the tissue was solid in this region. The left hypogastric nerve close to the tumor was inflamed and it was cut. The layer of the exfoliation was connected to the right side of the rectum, the tumor was isolated from the vagina, and the lower rectum was transected at a point 1 cm distal to the tumor with a 60-mm linear stapler. Reconstruction with a 31-mm circular stapler was performed using the double stapling technique. Operative time was 520 min with a blood loss of 320 ml. On the 9th post operative day, a rectovaginal fistula occurred, and ileostomy was performed. The patient was discharged from the hospital on the 25th postoperative day, and 4 months later, stoma closure was performed.
doi:10.1159/000256617
PMCID: PMC2988924  PMID: 21103248
Colorectal endometriosis; Lower rectum; Laparoscopically assisted low anterior resection
15.  Colovaginal anastomosis: an unusual complication of stapler use in restorative procedure after Hartmann operation 
Background
Rectovaginal fistula is uncommon after lower anterior resection for rectal cancer. The most leading cause of this complication is involvement of the posterior wall of the vagina into the staple line when firing the circular stapler.
Case presentation
A 50-year-old women underwent resection for obstructed carcinoma of the sigmoid colon with Hartmann procedure. Four months later she underwent restorative surgery with circular stapler. Following which she developed rectovaginal fistula. A transvaginal repair was performed but stool passing from vagina not per rectum. Laporotomy revealed colovaginal anastomosis, which was corrected accordingly. Patient had an uneventful recovery.
Conclusion
Inadvertent formation of colovaginal anastomosis associated with a rectovaginal fistula is a rare complication caused by the operator's error. The present case again highlights the importance of ensuring that the posterior wall of vagina is away from the staple line.
doi:10.1186/1477-7819-3-74
PMCID: PMC1315324  PMID: 16285887
16.  Functional outcome after perineal stapled prolapse resection for external rectal prolapse 
BMC Surgery  2010;10:9.
Background
A new surgical technique, the Perineal Stapled Prolapse resection (PSP) for external rectal prolapse was introduced in a feasibility study in 2008. This study now presents the first results of a larger patient group with functional outcome in a mid-term follow-up.
Methods
From December 2007 to April 2009 PSP was performed by the same surgeon team on patients with external rectal prolapse. The prolapse was completely pulled out and then axially cut open with a linear stapler at three and nine o'clock in lithotomy position. Finally, the prolapse was resected stepwise with the curved Contour® Transtar™ stapler at the prolapse's uptake. Perioperative morbidity and functional outcome were prospectively measured by appropriate scores.
Results
32 patients participated in the study; median age was 80 years (range 26-93). No intraoperative complications and 6.3% minor postoperative complications occurred. Median operation time was 30 minutes (15-65), hospital stay 5 days (2-19). Functional outcome data were available in 31 of the patients after a median follow-up of 6 months (4-22). Preoperative severe faecal incontinence disappeared postoperatively in 90% of patients with a reduction of the median Wexner score from 16 (4-20) to 1 (0-14) (P < 0.0001). No new incidence of constipation was reported.
Conclusions
The PSP is an elegant, fast and safe procedure, with good functional results.
Trial registration
ISRCTN68491191
doi:10.1186/1471-2482-10-9
PMCID: PMC2843648  PMID: 20205956
17.  STARR with Contour® Transtar™: prospective multicentre European study 
Colorectal Disease  2009;11(8):821-827.
Objective
The stapled transanal rectal resection (STARR) in patients with defecation disorders is limited by the shape and capacity of the circular stapler. A new device has been recently developed, the Contour® Transtar™ stapler, in order to improve the safety and effectiveness of the STARR technique. The study has been designed to confirm this declaration.
Method
From January to June 2007 a prospective European multicentre study of consecutive patients with defecation disorder caused by internal rectal prolapse underwent the new STARR technique. The assessment of perioperative morbidity and functional outcome after 6 weeks, 3 and 12 months was documented by different scores.
Results
In all 75 patients, median age 64, the Transtar procedure was performed with 9% intraoperative difficulties, 7% postoperative complications and no mortality. The mean reduction of the ODS score was −15.6 (95%−CI: −17.3 to −13.8, P < 0.0001), mean reduction of SSS was −12.6 (95%−CI: −14.2 to −11.2; P < 0.0001). 41% stated improvement of their continence status by CCF score, only 4 patients (5%) had deterioration.
Conclusion
The Transtar procedure is technically demanding, with good functional results similar to the conventional STARR.
doi:10.1111/j.1463-1318.2008.01714.x
PMCID: PMC2774156  PMID: 19175625
STARR; obstructive defecation syndrome; constipation; internal rectal prolapse; rectocele; incontinence
18.  Dynamic Magnetic Resonance Imaging Demonstrates the Integrity of Perineal Reconstruction following Cylindrical Abdominoperineal Excision with Reconstruction of the Pelvic Floor Using Porcine Collagen 
Case Reports in Medicine  2012;2012:752357.
A 72-year-old female presented with a six-month history of increased frequency of defecation, rectal bleeding, and severe rectal pain. Digital rectal examination and endoscopy revealed a low rectal lesion lying anteriorly. This was confirmed histologically as adenocarcinoma. Radiological staging was consistent with a T3N2 rectal tumour. Following long-course chemoradiotherapy repeat staging did not identify any metastatic disease. She underwent a laparoscopic cylindrical abdominoperineal excision with en bloc resection of the coccyx and posterior wall of the vagina with a negative circumferential resection margin. The perineal defect was reconstructed with Permacol (biological implant, Covidien) mesh. She had no clinical evidence of a perineal hernia at serial followup. Dynamic MRI images of the pelvic floor obtained during valsalva at 10 months revealed an intact pelvic floor. A control case that had undergone a conventional abdominoperineal excision with primary perineal closure without clinical evidence of herniation was also imaged. This confirmed subclinical perineal herniation with significant downward migration of the bowel and bladder below the pubococcygeal line. We eagerly await further evidence supporting a role for dynamic MR imaging in assessing the integrity of a reconstructed pelvic floor following cylindrical abdominoperineal excision.
doi:10.1155/2012/752357
PMCID: PMC3270543  PMID: 22312372
19.  The Use of Bovine Pericardial Buttress on Linear Stapler Fails to Reduce Pancreatic Fistula Incidence in a Porcine Pancreatic Transection Model 
HPB Surgery  2011;2011:624060.
We investigate the effectiveness of buttressing the surgical stapler to reduce postoperative pancreatic fistulae in a porcine model. As a pilot study, pigs (n = 6) underwent laparoscopic distal pancreatectomy using a standard stapler. Daily drain output and lipase were measured postoperative day 5 and 14. In a second study, pancreatic transection was performed to occlude the proximal and distal duct at the pancreatic neck using a standard stapler (n = 6), or stapler with bovine pericardial strip buttress (n = 6). Results. In pilot study, 3/6 animals had drain lipase greater than 3x serum on day 14. In the second series, drain volumes were not significantly different between buttressed and control groups on day 5 (55.3 ± 31.6 and 29.3 ± 14.2 cc, resp.), nor on day 14 (9.5 ± 4.2 cc and 2.5 ± 0.8 cc, resp., P = 0.13). Drain lipase was not statistically significant on day 5 (3,166 ± 1,433 and 6,063 ± 1,872 U/L, resp., P = 0.25) or day 14 (924 ± 541 and 360 ± 250 U/L). By definition, 3/6 developed pancreatic fistula; only one (control) demonstrating a contained collection arising from the staple line. Conclusion. Buttressed stapler failed to protect against pancreatic fistula in this rigorous surgical model.
doi:10.1155/2011/624060
PMCID: PMC3202096  PMID: 22114365
20.  Comparative Study of Hand-Sutured versus Circular Stapled Anastomosis for Gastrojejunostomy in Laparoscopy Assisted Distal Gastrectomy 
Journal of Gastric Cancer  2012;12(2):120-125.
Purpose
Mechanical stapler is regarded as a good alternative to the hand sewing technique, when used in gastric reconstruction. The circular stapling method has been widely applied to gastrectomy (open orlaparoscopic), for gastric cancer. We illustrated and compared the hand-sutured method to the circular stapling method, for Billroth-II, in patients who underwent laparoscopy assisted distal gastrectomy for gastric cancer.
Materials and Methods
Between April 2009 and May 2011, 60 patients who underwent laparoscopy assisted distal gastrectomy, with Billroth-II, were enrolled. Hand-sutured Billroth-II was performed in 40 patients (manual group) and circular stapler Billroth-II was performed in 20 patients (stapler group). Clinicopathological features and post-operative outcomes were evaluated and compared between the two groups.
Results
Nosignificant differences were observed in clinicopathologic parameters and post-operative outcomes, except in the operation times. Operation times and anastomosis times were significantly shorter in the stapler group (P=0.004 and P<0.001).
Conclusions
Compared to the hand-sutured method, the circular stapling method can be applied safely and more efficiently, when performing Billroth-II anastomosis, after laparoscopy assisted distal gastrectomy in patients with gastric cancer.
doi:10.5230/jgc.2012.12.2.120
PMCID: PMC3392323  PMID: 22792525
Laparoscopy; Gastric cancer; Billroth-II; Staple
21.  The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial 
BMC Surgery  2012;12:23.
Background
Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence.
The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative.
Methods
The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis.
Discussion
This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage.
Trial registration
NTR3080
doi:10.1186/1471-2482-12-23
PMCID: PMC3558481  PMID: 23153188
22.  Structure of the Perineal Membrane in Females: Gross and Microscopic Anatomy 
Obstetrics and gynecology  2008;111(3):686-693.
OBJECTIVE
To re-examine the anatomy of the perineal membrane and its anatomical relationships in whole-pelvis and histological serial section as well as gross anatomical dissection.
METHODS
Serial trichrome-stained histologic sections of 5 female pelvic specimens (0 to 37 years old) were examined. Specimens included the urethra, perineal membrane, vagina and surrounding structures. Macroscopic whole pelvis sections of 3 adults 28 to 56 years in axial, sagittal and coronal sections were also studied. Dissections of 6 female cadavers 48 to 90 years were also performed.
RESULTS
The perineal membrane is composed of 2 regions, one dorsal and one ventral. The dorsal portion consists of bilateral transverse fibrous sheets that attach the lateral wall of the vagina and perineal body to the ischiopubic ramus. This portion is devoid of striated muscle. The ventral portion is part of a solid 3-dimensional tissue mass in which several structures are embedded. It is intimately associated with the compressor urethrae and the urethrovaginal sphincter muscle of the distal urethra with the urethra and its surrounding connective. In this region the perineal membrane is continuous with the insertion of the arcus tendineus fascia pelvis. The levator ani muscles are connected with the cranial surface of the perineal membrane. The vestibular bulb and clitoral crus are fused with the membrane's caudal surface.
CONCLUSION
The structure of the perineal membrane is a complex 3-dimensional structure with two distinctly different dorsal and ventral regions; not a simple trilaminar sheet with perforating viscera.
doi:10.1097/AOG.0b013e318163a9a5
PMCID: PMC2775042  PMID: 18310372
perineal membrane; urogenital diaphragm; pelvic floor dysfunction; pelvic organ prolapse; anatomy; female
23.  Comparative Study between Staplers and Conventional(Hand-Sewn) Anastomosis in Gastrointestinal Surgery 
The Indian Journal of Surgery  2012;74(6):462-467.
Conventional (hand-sewn) technique of intestinal anastomosis has been in vogue for decades. Staplers which were developed to simplify surgery began to have significant impact. To compare staplers versus conventional anastomosis with respect to certain intra operative and post operative parameters. Prospective study from November 2008 to October 2010 in Hyderabad at OSMANIA, GANDHI, MNJ CANCER hospitals. 120 patients were divided into three groups of 40 each, depending on the surgery like posterior gastrojejunostomy, distal gastrectomy and reconstruction (Billroth II) and colorectal anastomosis. Of these 40 patients, 20 were in hand-sewn group and the other 20 in stapler group. Unpaired ‘t’ test was used to find ‘p’ value . ‘p’ value less than 0.05 was considered statistically significant. Total operating time was shortened in stapler group. No significant difference was found in terms of restoration of intestinal function, post-operative hospital stay, post-operative complications like anastomotic leak. Staplers can expedite surgery. They have better access to difficult—to—reach areas. Thus staplers can be beneficial though one should not forget the art of conventional suturing.
doi:10.1007/s12262-012-0450-7
PMCID: PMC3538000  PMID: 24293900
Intestinal anastomosis; Hand-sewn; Linear staplers; Circular staplers
24.  Comparison of standard 4-row versus 6-row 3-D linear cutter stapler in creation of gastrointestinal system anastomoses: a prospective randomized trial 
Clinics  2012;67(9):1035-1038.
OBJECTIVE:
This prospective study was conducted to compare the clinical outcomes of a 6-row 3-D linear cutter with the standard 4-row linear cutter in patients who underwent elective gastrointestinal surgery anastomosis.
METHOD:
Patients who underwent elective open gastrointestinal surgery that included stapled anastomosis using a linear cutter (Proximate®, Ethicon Endo-Surgery, Cincinnati, OH) between January 2011 and May 2011 were included in the study. The patients were randomly assigned to two groups according to the linear cutter that was used in the surgery: the standard 4-row cutter (the S group) or the new 6-row cutter (the N group). The groups were compared based on the patient demographic data, the laboratory parameters, the preoperative diagnosis, the surgery performed, the operation time, intra- or postoperative complications, the time to oral tolerance and the length of the hospital stay.
RESULTS:
The S group included 11 male and nine female patients with a mean age of 65±12 (35-84) years, while the N group included 13 male and eight female patients with a mean age of 62±11 (46-79) years (p = 0.448, p = 0.443, respectively). Anastomotic line bleeding was observed in eight (40%) patients in the S group and in one (4.7%) patient in the N group (p = 0.006). Dehiscence of the anastomosis line was observed in two (10%) patients in the S group and none in the N group (p = 0.131). Anastomotic leakage developed in three (15%) patients in the S group and in one (4.7%) patient in the N group (p = 0.269). The mean hospital stay was 12.65±6.1 days in the S group and 9.52±2.9 days in the N group (p = 0.043).
CONCLUSION:
The 6-row 3-D linear cutter is a safe and easily applied instrument that can be used to create anastomoses in gastrointestinal surgery. The new stapler provides some usage benefits and is also superior to the standard linear cutter with regard to anastomotic line bleeding.
doi:10.6061/clinics/2012(09)09
PMCID: PMC3438243  PMID: 23018300
Anastomosis; Linear Stapler; 4-Row Staple Line; Gastrointestinal Surgery
25.  Laparoscopic surgical technique to facilitate management of high anorectal malformations – report of seven cases 
Anorectal malformations (ARMs) occur in approximately 1 per 5000 live births. The most commonly used procedure for repair of high ARMs is posterior sagittal anorectoplasty (PSARP). This operation is performed entirely through a perineal approach. The first report of laparoscopically assisted anorectal pull-through (LAARP) for repair of ARMs was presented by Georgeson in 2000. The aim is presenting early experience with laparoscopically assisted anorectal pull-through technique in boys with high anorectal malformations. In the last 5 years 7 boys (9 months to 2 years old) with high ARMs were operated on using the LAARP technique. Laparoscopically the rectal pouch was exposed down to the urethral fistula, which was clipped and divided. Externally, the centre of the muscle complex was identified using an electrical stimulator. In the first 4 patients after a midline incision of 2 cm at the planned anoplasty site, a tunnel to the pelvis was created bluntly and dilated with Hegar probes under laparoscopic control. In the last 3 boys a minimal PSARP was done creating a channel into the pelvis. The separated rectum was pulled down and sutured to the perineum. Laparoscopic mobilization of the rectal pouch and fistula division was possible in all cases. There were no intraoperative complications except one ureteral injury. Patients were discharged home on post-operative day 5 to 7. The early results prove that LAARP, an alternative option to PSARP for treatment of imperforate anus, offers many advantages, including excellent visualization of the pelvic anatomical structures, accurate placement of the bowel into the muscle complex and a minimally invasive abdominal and perineal incision. It allows for shorter hospital stay and faster recovery. However, to compare the functional results against the standard procedure (PSARP), longer follow-up of all patients is necessary.
doi:10.5114/wiitm.2011.24693
PMCID: PMC3516939  PMID: 23255974
laparoscopy; anorectal malformations; laparoscopically assisted anorectal pull-through (LAARP); children

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