Naturally Banded Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Procedure: LSG; Procedure: LSG with omental band

• Registration Number: NCT05603338
• Lead Sponsor: Minia University

Brief Summary

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Detailed Description

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Study Start: 2022-11-01
• Study First Posted: 2022-11-02
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
• patients fit for laparoscopic surgery
• give approval to share in the study
• previous restrictive bariatric procedure

Exclusion Criteria

• patients unfit for surgery
• patients aged less than 18 and older than 60
• patient with previous upper abdominal surgery either for obesity or other diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LSG	LSG	just laparoscopic sleeve gastrectomy without banding
LSG with omental band	LSG with omental band	laparoscopic sleeve gastrectomy with omental banding

Primary Outcome Measures

Name	Time	Method
the effect on weight loss	12 months	the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
the size of gastric pouch at one year	12 months	the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study

Secondary Outcome Measures

Name	Time	Method
operative time	6 hours	operative time in minutes from skin incision to skin closure
the effect on comorbidities	12 monthts	change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
the incidences of complications	12 monthss	the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy

Trial Locations

Locations (1)

Minia university hospital; 🇪🇬 Minya, Egypt