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Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02325141
Enrollment
130
Registered
2014-12-24
Start date
2011-01-31
Completion date
2013-01-31
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

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.

Interventions

PROCEDURElaparoscopic sleeve gastrectomy

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Previous bariatric surgery

Design outcomes

Primary

MeasureTime frame
number pf patients developing postoperative gastric leakage0ne year

Secondary

MeasureTime frame
percent of patients with excess weight lossone year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026