Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

Not Applicable

Not yet recruiting

• Conditions: Obesity, Morbid
• Interventions: Procedure: silicone band; Procedure: natural band

• Registration Number: NCT06298942
• Lead Sponsor: Minia University

Brief Summary

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

Detailed Description

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost

Study Timeline

• Study First Submitted: 2024-02-21
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Study Start: 2024-03-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Exclusion Criteria

• patients refused to share in the study
• patients unfit for surgery
• patients aged less than 18 and older than 65
• patient with previous upper abdominal surgery either for obesity or other diseases
• revisional bariatric procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silicone band	silicone band	to use a synesthetic band with sleeve gastrectomy
natural band	natural band	to use an round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
total cost	12 hours	total operative cost in Egyptian pound (LE)
food intolerance	1 year	food intolerance at one year food tolerance arabic score questionnaire

Secondary Outcome Measures

Name	Time	Method
%EWL	1 year	percentage of weight loss at one year measured as (initial weight - follow-up weight) / (initial weight - bodyweight at a BMI of 25 kg/ m2) x 100
improvement of comorbidities	1 year	the incidence of improvement of comorbidities
complications rate	1 year	the incidence of early and late complications according to Clavien-Dindo (CD)