Phase III Prospectively Randomized Trial of Perioperative 5-FU After Curative Resection for Colon Cancer: An Intergroup Trial of the ECOG-ACRIN Cancer Research Group (E1292).

BACKGROUND: Studies suggest that adjuvant chemotherapy should be initiated at the earliest possible time. The Eastern Cooperative Oncology Group (ECOG) and Intergroup evaluated the effect of perioperative fluorouracil (5-FU) on overall survival (OS) for colon cancer. PATIENTS AND METHODS: This phase III trial randomized patients to receive continuous infusional 5-FU for 7 days starting within 24 h after curative resection (arm A) or no perioperative 5-FU (arm B). Patients with Dukes' B3 and C disease received adjuvant chemotherapy per standard of care. The primary endpoint of the trial was overall survival in patients with Dukes' B3 and C disease. The secondary objective was to determine whether a week of perioperative infusion would affect survival in patients with Dukes' B2 colon cancer with no additional chemotherapy. RESULTS: From August 1993 to May 2000, 859 patients were enrolled and 855 randomized (arm A: 427; arm B: 428). The trial was terminated early due to slow accrual. The median follow-up is 15.4 years (0.03-20.3 years). Among patients with Dukes' B3 and C disease, there was no statistically significant difference in OS [median 10.3 years (95% CI 8.4, 13.2) for perioperative chemotherapy and 9.3 years (95% CI 5.7, 12.3) for no perioperative therapy, one-sided log-rank p = 0.178, HR = 0.88 (95% CI 0.66, 1.16)] or disease-free survival (DFS). For patients with Dukes' B2 disease, there was also no significant difference in OS (median 16.1 versus 12.9 years) or DFS. There was no difference between treatment arms in operative complications. One week of continuous infusion of 5-FU was tolerable; 18% of arm A patients experienced grade 3 or greater toxicity.

Partially covered esophageal stents cause bowel injury when used to treat complications of bariatric surgery.

BACKGROUND: We hypothesized that an esophageal nitinol stent that is mainly silicone-covered but partially uncovered may allow tissue ingrowth and decrease the migration rate seen with fully covered stents and still allow safe stent removal. The aim of this study was to evaluate the first human results of using partially covered stents for anastomotic complications of bariatric surgery. METHODS: This was a retrospective evaluation of all patients with staple-line complications after bariatric surgery who received a partly covered stent at a single tertiary-care bariatric center. The stents varied in length from 10 to 15 cm and in diameter from 18 to 23 mm. RESULTS: From April 2009 to April 2010, eight patients received partially covered stents on 14 separate occasions. The indications were gastrojejunal stricture in four, acute leak in two, acute leak followed by a later stricture in one, and a perforated anastomotic ulcer in one patient. Single stents were placed in 12 sessions and two overlapping stents in two sessions. At the time of stent deployment, one patient had the uncovered proximal end of the stent in the stomach, with all others in the distal esophagus. Immediate symptom improvement occurred in 12/14 stent placements. Oral nutrition was initiated for 10/14 stent treatments within 48 h. Stents were removed after 25 ± 10 days. Minor stent displacement occurred with 9/13 stents, with the proximal end of the stent moving into the stomach, though the site of pathology remained covered. The stents were difficult to remove when tissue ingrowth was present. One patient required laparoscopic removal and one required two endoscopy sessions for removal. At the time of removal of ten stents, where the proximal end was found in the stomach, four had gastric ulceration, three had gastric mucosa replaced by granulation tissue, and three had normal gastric mucosa. In four cases where the proximal portion of the stent stayed in the esophagus, the esophageal deployment zone had abnormalities: three with granulation tissue and one with denuding of the esophageal mucosa. The distal uncovered portion of the stent in the Roux limb never became embedded in the mucosa and caused minimal injury. CONCLUSIONS: A partially covered stent was successful in keeping the site of the pathology covered and provided rapid symptom improvement and oral nutrition in most patients. The proximal end of the stent generally moved from the esophagus to the stomach, probably due to esophageal peristalsis. The proximal uncovered portion of the stent causes significant bowel mucosal injury and sometimes becomes embedded in the esophagus or the stomach, making removal difficult. We no longer use partially covered stents.

Management of postsurgical leaks in the bariatric patient.

Postsurgical leaks after bariatric procedures are a significant cause of morbidity and mortality. They usually arise from anastomotic and staple line failures that are attributed to surgical technique, ischemia, and patient comorbid conditions. Timely diagnosis from subtle clinical clues is the key to appropriate management. Traditional treatment consists of adequate control of the intra-abdominal infection via surgical or percutaneous drainage maneuvers, antibiotics, and nutrition support via parenteral or feeding tube routes. Recently, endoscopically placed covered esophageal stents have been used to exclude the leak site, allowing oral nutrition and speeding healing.

In search of the best peritoneal adhesion model: comparison of different techniques in a rat model.

BACKGROUND: Adhesion-related complications after abdominal surgery result in significant morbidity and costs. Results from animal studies investigating prevention or treatment of adhesions are limited due to lack of consistency in existing animal models. The aim of this study was to compare quality and quantity of adhesions in four different models and to find the best model. MATERIALS AND METHODS: This study was approved by the University of Missouri Animal Care and Use Committee (ACUC). Forty female rats were randomly assigned to four different groups of 10 animals each. Adhesion created was performed utilizing the four techniques: Group 1 - parietal peritoneum excision (PPE), Group 2 - parietal peritoneum abrasion (PPA), Group 3 - peritoneal button creation (PBC), and Group 4 - cecal abrasion (CA). Rats were allowed to recover and necropsy was performed on postoperative d 14. Adhesions were scored by an established quantitative and qualitative scoring systems. The midline incision served as the control in each animal. RESULTS: The four groups were not equal with respect to both quantity score (P<0.001) and quality score (P=0.042). The PBC group had the highest quantity of adhesions. The highest quality of adhesion was seen in the PPE group. A multivariate analysis carried out to quantify the performance of each model clearly demonstrated that PBC exhibited the best results in terms of both quantity and quality. CONCLUSIONS: The button technique (PBC) is most consistent and reproducible technique for an intra-abdominal adhesion model. This model can help in the study and development of substances to prevent adhesion formation in the future.

Transvaginal repair of a large chronic porcine ventral hernia with synthetic mesh using NOTES.

BACKGROUND: Ventral incisional hernias still remain a common surgical problem. We tested the feasibility of transvaginal placement of a large synthetic mesh to repair a porcine hernia. METHODS: Seven pigs were used in this survival model. Each animal had creation of a 5-cm hernia defect and underwent a transvaginal repair of the defect with synthetic mesh. A single colpotomy was made using a 12-cm trocar for an overtube. The mesh was cut to size and placed through the trocar. A single-channel gastroscope with an endoscopic atraumatic grasper was used for grasping sutures. Further fascial sutures were placed every 5 cm. RESULTS: Mesh repair was feasible in all 7 animals. Mean operative time was 133 minutes. Technical difficulties were encountered. No gross contamination was seen at the time of necropsy. However, 5 animals had positive mesh cultures; 7 had positive cultures in the rectouterine space in enrichment broth or on direct culture. CONCLUSION: Transvaginal placement of synthetic mesh to repair a large porcine hernia using NOTES is challenging but feasible. Future studies need to be conducted to develop better techniques and determine the significance of mesh contamination.

Transvaginal cholecystectomy by using a prototype flexible clip applier.

BACKGROUND: Currently, no endoscopic clips have been proven to be effective in ligating the cystic duct in natural orifice transluminal endoscopic surgery (NOTES) hybrid cholecystectomy. OBJECTIVE: To determine the safety and feasibility of a prototype endoscopic flexible clip applier, which is the only flexible device that deploys a zero-gap clip. DESIGN: Pilot study in a survival porcine model. Necropsy was performed at 2 weeks postprocedure. SETTING: University of Missouri animal laboratory, Columbia, Missouri. INTERVENTION: Transvaginal cholecystectomy was performed on 6 survival pigs using the NOTES Toolbox 1.0. MAIN OUTCOME MEASUREMENTS: Safety and feasibility of the described instrument. Investigators were asked to fill out a standardized, blinded questionnaire on the ease of use and functionality of the flexible clip applier. RESULTS: Clipping of the cystic duct was achieved with the flexible clip applier in all 6 pigs. The mean time for completion of clipping of the cystic duct was 9 minutes. Multiple attempts were required to successfully fire the clip in 2 of 6 pigs. We were unable to visualize the tip of the clip before deployment. Difficulty releasing the clip from the applier once fired and challenges in clip loading were encountered. The clips were visualized in place at necropsy, with no bile leakage, evidence of infection, or injury to surrounding structures seen in any cases. LIMITATIONS: Preclinical animal model. CONCLUSION: The prototype flexible clip applier showed adequate safety and was feasible in clipping the cystic duct in all animals. Design efforts to improve clip visualization, loading, and release are underway.

Pilot data on the endoscopic placement of covered metal stents to treat gastrojejunal leaks in a porcine model.

BACKGROUND: Placement of stents may be an alternative option to treat gastrojejunal (GJ) anastomotic leaks after Roux-en-Y gastric bypass (RYGB) surgery. The aim was to evaluate the performance of a covered metal stent (Alimaxx-E, 18 x 100 mm) across a GJ leak in a porcine model. METHODS: In eight pigs, a RYGB was performed and a 1-cm leak was created. A retrogastric and anterogastric GJ was performed equally with four pigs in each group. Stents were placed across the GJ anastomosis using endoscopy and fluoroscopy. The endpoints were position of the stents, healing of the leak, and complications at necropsy. RESULTS: Stent placement was feasible in all pigs it was attempted. In the retrogastric GJ group, pigs without stents survived 2 weeks without complications. Two pigs with stents died on postoperative days (PODs) 4 and 5. In the anterogastric GJ group, one pig with one stent survived 2 weeks with healing of the leak but with stent migration into the Roux limb. The remaining three pigs died between PODs 4 and 6. Pressure necrosis of the Roux limb caused by the distal end of the stent was found in all. CONCLUSIONS: Placement of fully covered metal stents is feasible. The use of small pigs with a thin small bowel wall in combination with relatively large stents was most likely the reason for complications found in all stented animals. Further studies of GJ leaks using these stents will require larger pigs or a different species.

Single-incision laparoscopic cholecystectomy using conventional instruments: early experience in comparison with the gold standard.

BACKGROUND: The aim of this pilot study was to describe our initial experience with single-incision laparoscopic cholecystectomy (SILC) using conventional laparoscopic equipment in comparison with concurrent patients undergoing conventional multiincision laparoscopic cholecystectomy. STUDY DESIGN: During the 7-month study period, data from all consecutive patients undergoing SILC by two surgeons were retrospectively analyzed and compared with data from patients undergoing conventional laparoscopic cholecystectomy by the same surgeons during the same time period. Outcomes measures included completion rate of attempted SILC, operative time, length of hospital stay, postoperative pain, and assessment of complications. RESULTS: From 51 laparoscopic cholecystectomies performed during the study period, 29 were attempted using single-incision technique and 22 were performed using the conventional four incisions. Of the attempted SILC cases, 14 (48%) were successfully completed, with the remainder requiring one to three additional skin incisions. There were no conversions to open in either group. Operative time was significantly longer in SILC cases compared with conventional laparoscopic cholecystectomy (85 versus 67 minutes; p = 0.01). There was a tendency toward greater postoperative pain in the SILC group. No substantial difference in complications was identified. CONCLUSIONS: SILC using conventional laparoscopic instrumentation is an effective alternative to standard four-incision laparoscopic cholecystectomy in selected patients. Development of a standardized technique and additional experience is needed for more consistent success. Additional studies of SILC are needed to demonstrate safety, define selection criteria, and determine any benefits over conventional laparoscopic cholecystectomy.

Transgastric placement of biologic mesh to the anterior abdominal wall.

BACKGROUND: Incisional hernia repairs have a risk of wound complications that may be decreased using a natural orifice transluminal endoscopic surgery (NOTES) approach. The aim of this study was to determine the feasibility and safety of transgastric mesh placement to the anterior abdominal wall in a porcine model as a precursor to future studies of NOTES ventral hernia repair. METHODS: The procedure was done under sterile conditions with a double lumen endoscope using a plastic overtube. The endoscope was placed in the stomach preloaded with an overtube. Entrance of the endoscope and overtube into the peritoneal cavity was performed with the percutaneous endoscopic gastrostomy (PEG) technique. A 13 x 15 cm Surgisis Gold mesh with four corner sutures was delivered through the overtube. Transfascial suture passer and endoscopic grasper were used to externalize the sutures and attach the mesh to the anterior abdominal wall. The gastrotomy was closed with a transabdominal gastropexy. The pigs were sacrificed at 2 weeks. RESULTS: Mesh placement was performed in five pigs. Operative time was 215 min (standard deviation, SD 99 min). The most difficult portion of the procedure involved manipulating the gastric overtube, likely exposing the mesh to bacteria in the stomach. Culture-positive abscesses were present at the mesh in 3/5 animals. The mesh appeared intact in 4/5 animals; one of the infected meshes had delamination of 50% of the mesh. Adhesions to the mesh surface varied from 2% to 100%. At 2 weeks, median mesh size was 116 cm2 (range 96-166 cm2) and median contraction was 41% (range 15-51%). Histologic evaluations demonstrated marked inflammation and fibrosis progressing into the mesh material. CONCLUSIONS: Totally endoscopic transgastric delivery and fixation of a biologic mesh to the anterior abdominal wall is feasible. Challenges remain in designing systems for mesh delivery that exclude gastric content. Once these problems can be surmounted NOTES ventral hernia repair may become an option in man.

Laparoscopic appendectomy--is it worth the cost? Trend analysis in the US from 2000 to 2005.

BACKGROUND: Although laparoscopic appendectomy is widely used for treatment of appendicitis, it is still unclear if it is superior to the open approach. STUDY DESIGN: From the Nationwide Inpatient Sample 2000 to 2005, hospitalizations with the primary ICD-9 procedure code of laparoscopic (LA) and open appendectomy (OA) were included in this study. Outcomes of length of stay, costs, and complications were assessed by stratified analysis for uncomplicated and complicated appendicitis (perforation or abscess). Regression methods were used to adjust for covariates and to detect trends. Costs were rescaled using the hospital and related services portion of the Medical Consumer Price Index. RESULTS: Between 2000 and 2005, 132,663 (56.3%) patients underwent OA and 102,810 (43.7%) had LA. Frequency of LA increased from 32.2% to 58.0% (p < 0.001); conversion rates decreased from 9.9% to 6.9% (p < 0.001). Covariate adjusted length of stay for LA was approximately 15% shorter than for OA in both uncomplicated and complicated cases (p < 0.001). Adjusted costs for LA were 22% higher in uncomplicated appendicitis and 9% higher in patients with complicated appendicitis (p < 0.001). Costs and length of stay decreased over time in OA and LA. The risk for a complication was higher in the LA group (p < 0.05, odds ratio=1.07, 95% CI 1.00 to 1.14) with uncomplicated appendicitis. CONCLUSIONS: LA results in higher costs and increased morbidity for patients with uncomplicated appendicitis. Nevertheless, LA is increasingly used. Patients undergoing LA benefit from a slightly shorter hospital stay. In general, open appendectomy may be the preferred approach for patients with acute appendicitis, with indication for LA in selected subgroups of patients.

Colonic sterilization for natural orifice translumenal endoscopic surgery (NOTES) procedures: a comparison of two decontamination protocols.

BACKGROUND: This study aimed to evaluate the effect of two different sterilization protocols on the bacterial counts in the swine colon as preparation for natural orifice translumenal endoscopic surgery (NOTES) surgery. METHODS: In this study, 16 swine were randomized to two different colonic sterilization protocols: low colonic irrigation using 300 ml of a 1:1 dilution of 10% povidone-iodine (Betadine) with sterile saline, followed by 1 g of cefoxitin dissolved in 300 ml of saline or two consecutive 300-ml irrigations using a quaternary ammonium antimicrobial agent (Onamer M). Colonic cultures were taken before colonic cleansing after a decontamination protocol and after completion of the NOTES procedure. The Invitrogen live/dead bacterial viability kit was used to assess for change in the bacterial load. A qualitative culture of peritoneal fluid was obtained at the end of the NOTES procedure. Colon mucosal biopsies obtained immediately after the sterilization procedure and at the 2-week necropsy point were evaluated for mucosal changes. RESULTS: Protocol 1 resulted in an average 93% decrease in live colonic bacteria versus 90% with protocol 2 (nonsignificant difference). After a NOTES procedure, group 1 had a 62% increase in live bacteria and group 2 had a 31% increase (nonsignificant difference). Peritoneal cultures also were obtained. Bacteria were isolated from the peritoneal fluid of all the animals, and two or more species were isolated from 75% of the animals. There was no evidence of peritoneal infection at necropsy. Reactive epithelial changes and mild inflammation were the only pathologic abnormalities. No changes were noted at histologic evaluation of colonic mucosa after 2 weeks, demonstrating that these were temporary changes. CONCLUSION: Colonic irrigation with Betadine and antibiotics are as effective for bacterial decontamination of the swine colon as a quaternary ammonium compound. The results of this study support the use of either protocol. Despite thorough decontamination, peritoneal contamination occurs. The significance of this for humans is unknown.

Lessons learned establishing an animal model for endoscopic stent placement to treat gastrojejunal anastomotic leaks after gastric bypass.

BACKGROUND: Anastomotic leaks after Roux-en-Y gastric bypass (RYGB) cause significant morbidity and mortality. Placement of enteral stents may be an improvement to the current treatment, which is withholding of oral intake and total parenteral nutrition. METHODS: We established an open RYGB porcine model with a leak at the gastrojejunostomy in three pigs. A pilot study was then performed in five pigs, where Polyflex stents were placed across the leaking anastomosis and fixed with transmural sutures to the Roux limb. After 2 weeks, endoscopy, fluoroscopy, and necropsy were performed. RESULTS: One pig without stent died on the second postoperative day (POD) due to a volvulus unrelated to the leak. In the other two pigs, leaks with large abscesses were found at necropsy. Stents were placed in five pigs but required open surgical manipulation of the delivery system. One pig died on POD 3 due to a perforation in the posterior gastric wall likely caused by the rigid delivery system. One pig died from gastrojejunostomy leakage on POD 5. The leaks were healed in the remaining three pigs after 2 weeks. In one pig, a perforation of the jejunum 4 cm distal to the anastomosis was found. Stent migration to some extent was seen in all pigs. CONCLUSION: Stent placement and fixation were feasible but had a high complication rate for treatment of a leaking gastrojejunal anastomosis in the open porcine model. The stent may have contributed to healing the leak in some pigs. Further studies should focus on improving stent delivery, sealing of the leak, and prevention of stent migration.

Placement of a covered polyester stent prevents complications from a colorectal anastomotic leak and supports healing: randomized controlled trial in a large animal model.

BACKGROUND: Anastomotic leaks after colorectal operation continue to be a significant cause of morbidity. A covered endoluminal stent could seal a leak and eliminate the need for diversion. The aim of this study was to test the efficacy of a temporary covered stent to prevent leak related complications. METHODS: Sixteen adult pigs (80-120 lbs) underwent open transection of the rectosigmoid followed by anastomosis with a circular stapler. Eight animals (study group) underwent endoscopic placement of a 21-mm covered polyester stent. Eight control group animals were left without stents. In all animals, a 2-cm leak was created along the anterior portion of the anastomosis. The animals were killed after 2 weeks and evaluated for abdominal infection, fistulae, and adhesions. The anastomosis was excised and the following parameters were assessed by a pathologist blinded to treatment: mucosal interruption (mm), inflammatory response, collagen type I and III, granulation, and fibrosis (grade 0-4). RESULTS: Stents were spontaneously expelled between postoperative days 6 and 9. At necropsy, none of the animals in the study group had leak related complications, whereas in the control group, 5 (63%) developed intraabdominal infection (4 abscesses, 1 fistula) at the anastomosis (P = .002). Dense adhesions to the anastomosis were found in 7 (88%) control animals. On histology, anastomotic sites in the study group had significantly less mucosal interruption and granulation. Two pigs in the study group died on postoperative day 7, one due to evisceration and one from bladder necrosis. The mortality result is not different from controls (P = .47), both events seem to be unrelated to stent placement. CONCLUSION: Temporary placement of a covered polyester stent across a colorectal anastomosis prevents leak-related complications and supports the healing of anastomotic leaks.

Nationwide impact of laparoscopic lysis of adhesions in the management of intestinal obstruction in the US.

BACKGROUND: Treatment of adhesion-related complications is cost intensive and presents a considerable burden to the health care system. The objective of this study was to compare open (OLA) and laparoscopic lysis of adhesions (LLA) in the treatment of intestinal obstruction, based on a nationwide representative sample. STUDY DESIGN: Patients with intestinal obstruction undergoing OLA, LLA, and conversion were identified from the 2002 National Inpatient Sample. After propensity methods were used to adjust for covariates including patient demographics, hospital characteristics, and comorbidities, the impact of OLA and LLA was analyzed concerning in-hospital mortality, postoperative complications, length of stay (LOS), and in-hospital costs. RESULTS: Of 6,165 patients, 88.6% underwent OLA and 11.4% had LLA. Conversion was required in 17.2% of LLA patients. Unadjusted mortality was equal between LLA and conversion (1.7%) and half the rate compared with OLA (3.4%) (p = 0.014). After adjusting with propensity methods, the odds of complications in the LLA group (intention to treat) were 25% less than in the OLA (p = 0.008). The LLA group had a 27% shorter LOS (p = 0.0001) and was 9% less expensive than the OLA group (p = 0.0003). There was no statistical significant difference for LOS, complications, and costs between the conversion and OLA groups. CONCLUSIONS: Results from this study suggest that when LLA is applied to selected patients with intestinal obstruction, there are reductions in postoperative complications, LOS, and costs. Prospective studies are needed to confirm these data and better identify the subgroup of patients who have improved outcomes with LLA.

Management of anastomotic leaks after Roux-en-Y bypass using self-expanding polyester stents.

BACKGROUND: To analyze the outcomes of a series of endoscopically placed polyester self-expanding polyflex stents (SEPSs) for the management of anastomotic leaks after Roux-en-Y bypass. Anastomotic leaks after gastric bypass cause significant morbidity and mortality. Covered polyester SEPSs might have a role in the treatment of these leaks. METHODS: A retrospective chart review was performed from January 2006 to November 2006 that included all acute and chronic leaks treated with SEPSs. RESULTS: A total of 6 patients were treated with stents, with a mean procedure time of 22 minutes. Of these 6 patients, 5 had acute postoperative leaks and 1 had a chronic fistula. Five patients started oral intake 1-6 days after their procedure. All acute leaks had complete healing at a median of 44 days. The patient with a chronic gastrocutaneous fistula required revisional surgery for fistula closure. In addition, 5 patients had stent migration, and 3 required stent replacement. CONCLUSION: An endoscopically placed SEPS provides a less-invasive alternative to treat acute anastomotic leaks after Roux-en-Y bypass while simultaneously allowing oral intake. The results of this case series have demonstrated this treatment to be safe and effective.

Stent placement for benign colonic stenosis: case report, review of the literature, and animal pilot data.

BACKGROUND: Permanent metal stent placement for malignant intestinal obstruction has been proven to be efficient. Temporary stents for benign conditions of the colon and rectum are less studied. This is a case study, review of the literature, and observation from an animal model on placement of stents in the colorectum for benign disease. MATERIALS AND METHODS: A 55-year-old man presented with recurrent obstructions from a benign stricture of the distal sigmoid colon. After failed balloon dilations, a polyester coated stent was placed. The purpose of the stent was to improve symptoms and avoid surgery. The stent was expelled after 5 days. We conducted a literature review of stents placed for benign colorectal strictures and an animal study to evaluate stent migration. RESULTS: In the literature, there were 53 reports of uncovered metal stents, four covered metal stents, and six polyester stents. Patency rates were 71%, and migration rate was 43%. Migration occurred earlier with polyester stents (mean=8 days) versus covered (32 days) or uncovered metal stents (112 days). Severe complications were seen in 23% of patients. Four 45-kg pigs underwent rectosigmoid transection with a 21-mm anastomosis and endoscopic placement of a Polyflex stent. Two stents were secured with suture. Stents without fixation were expelled within 24 h of surgery. Stents with fixation were expelled between postoperative days 2 and 14. CONCLUSION: Stents for the treatment of benign colorectal strictures are safe, with comparable patency rates between stent types. Metal stents can cause severe complications. In a pig model, covered polyester stents tend to migrate early even with fixation. Further investigation needs to focus on new stent designs and/or better fixation.

Gastrotomy creation and closure for NOTES using a gastropexy technique (with video).

BACKGROUND: Safe and efficient gastrotomy creation and closure is pivotal for natural orifice transluminal endoscopic surgery (NOTES). OBJECTIVE: To test a method of transgastric access and closure with commercially available devices. DESIGN: An animal survival study. SETTING: University hospital. PATIENTS: Fifteen pigs. INTERVENTIONS: By using a surgical suture passer, under endoscopic guidance, 3 percutaneous stay sutures were placed, in a triangular fashion, through the gastric wall. A gastrotomy was created with a dilation balloon, which was introduced over a guidewire through the gastric wall in the center of the 3 sutures. After performing a NOTES procedure, the gastrotomy was closed by tying the sutures. Necropsies were performed after 2 to 4 weeks. MAIN OUTCOME MEASUREMENTS: Success and time of gastrotomy creation and closure, and intraoperative and postoperative complications. RESULTS: Gastrotomies were successfully created and closed in all the animals. The median time to create a gastrotomy was 19 minutes (range 11-85 minutes), and the median closure time was 1 minute (range 1-45 minutes). One pig died on postoperative day 1 because of peritonitis caused by a leaking gastrotomy site that extended beyond the stay sutures. There were no other gastrotomy-related complications. All gastrotomies were well healed at the necropsy. LIMITATION: No control group. CONCLUSIONS: We evaluated a simple method by using the principles of the PEG technique combined with a gastropexy, which is familiar to the majority of endoscopists. Strict attention to the gastrotomy site is needed, because one leak was from the gastrotomy site that extended beyond the stay sutures.