Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: laparoscopic sleeve gastrectomy

• Registration Number: NCT02325141
• Lead Sponsor: Mansoura University

Brief Summary

Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.

Detailed Description

Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Last Update Submitted: 2014-12-19
• Study First Posted: 2014-12-24
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Body mass index >40 or >35 with hypertension or DM

Exclusion Criteria

Previous bariatric surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LSG	laparoscopic sleeve gastrectomy	patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter
BTX-LSG	laparoscopic sleeve gastrectomy	patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter

Primary Outcome Measures

Name	Time	Method
number pf patients developing postoperative gastric leakage	0ne year

Secondary Outcome Measures

Name	Time	Method
percent of patients with excess weight loss	one year