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Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

NCT ID: NCT02325141

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LSG

patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter

Group Type ACTIVE_COMPARATOR

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

creation of a gastric tube of 100cc using a stapler.

BTX-LSG

patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter

Group Type ACTIVE_COMPARATOR

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

creation of a gastric tube of 100cc using a stapler.

Interventions

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laparoscopic sleeve gastrectomy

creation of a gastric tube of 100cc using a stapler.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Previous bariatric surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Youssef Mohamed

assistant professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MFM201040

Identifier Type: -

Identifier Source: org_study_id