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Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

M

Mansoura University

Status

Completed

Conditions

Morbid Obesity

Treatments

Procedure: laparoscopic sleeve gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02325141
MFM201040

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Previous bariatric surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

130 participants in 2 patient groups

LSG
Active Comparator group
Description:
patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter
Treatment:
Procedure: laparoscopic sleeve gastrectomy
BTX-LSG
Active Comparator group
Description:
patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter
Treatment:
Procedure: laparoscopic sleeve gastrectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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