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).

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.

Transvaginal cholecystectomy without laparoscopic support using prototype flexible endoscopic instruments in a porcine model.

Background: Transvaginal cholecystectomy with laparoscopic assistance has been performed safely in humans. The next goal was to develop a natural orifice transluminal endoscopic surgery (NOTES) technique to perform cholecystectomy without laparoscopic instruments using one flexible endoscope and flexible accessories. The aim of the study was to test the feasibility of the procedure in a survival porcine model.

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.

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.

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.

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.

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.

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.

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.

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).

Laparoscopic Nissen fundoplication is a good option in patients with abnormal esophageal motility.

Background: Patients with gastroesophageal reflux disease (GERD) and abnormal esophageal motility are the most controversial subgroup of surgically treated patients because of potentially increased risk of postoperative dysphagia. Our study aim was to determine if Nissen fundoplication is associated with increased postoperative dysphagia in patients with ineffective esophageal motility.

Methods: Medical records of all adult (>18 years old) patients who underwent laparoscopic Nissen fundoplication for GERD over 8 years were reviewed retrospectively.

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.

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.

Transgastric cholecystectomy using a prototype endoscope with 2 deflecting working channels (with video).

Background: Transgastric cholecystectomy has been shown to be feasible in animal models and human case reports but cumbersome with current available instrumentation.

Objective: To evaluate a prototype endoscope with 2 working channels with deflectors at the distal tip for performance of transgastric cholecystectomy.

Design: Animal study, nonsurvival and survival.

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.

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.

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.

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.

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.

Endoscopic colotomy closure for natural orifice transluminal endoscopic surgery using a T-fastener prototype in comparison to conventional laparoscopic suture closure.

Background: Safe and efficient endoscopic closure of a colotomy is essential for transcolonic peritoneal access or endoscopic full-thickness resection of the colon, if open or laparoscopic surgery is to be avoided.

Objective: To compare the feasibility and safety of colotomy closure with the newly developed Tissue Approximation System (TAS, Ethicon Endo-Surgery, Inc.) to conventional laparoscopic suture closure.