Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

Morbid Obesity Clinical Trial

Official title:

Laparoscopic Sleeve Gasterectomy With or Without Pyloric Sphincter Botulinum Neurotoxin Injection: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325141
• Other study ID #: MFM201040
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: December 19, 2014
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: 'Mansoura Faculty of medicine
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Previous bariatric surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• laparoscopic sleeve gastrectomy
creation of a gastric tube of 100cc using a stapler.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number pf patients developing postoperative gastric leakage		0ne year	Yes
Secondary	percent of patients with excess weight loss		one year	Yes