Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Procedure: sleeve without plication; Procedure: sleeve with plication

• Registration Number: NCT04144361
• Lead Sponsor: Minia University

Brief Summary

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding

Detailed Description

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect

Study Timeline

• Study First Submitted: 2019-10-20
• Study First Submitted QC: 2019-10-27
• Study First Posted: 2019-10-30
• Study Start: 2019-12-27
• Primary Completion: 2020-08-20
• Study Completion: 2020-08-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-28
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 60
• 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
sleeve without plication	sleeve without plication	sleeve gastrectomy on bougie 36 without plication
sleeve with plication	sleeve with plication	sleeve gastrectomy on bougie 42 without plication

Primary Outcome Measures

Name	Time	Method
the incidence of postoperative stable line bleeding	2-24 hours	early postoperative bleeding from stable line
the incidence of stable line leakage	1-30 days	leak from stable line

Trial Locations

Locations (2)

Faculty of medicine; 🇪🇬 Minya, Egypt

Minya university hospital; 🇪🇬 Minya, Egypt