Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2020-08-20

Brief Summary

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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

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Detailed Description

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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

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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sleeve without plication

sleeve gastrectomy on bougie 36 without plication

Group Type EXPERIMENTAL

sleeve without plication

Intervention Type PROCEDURE

sleeve without plication

sleeve with plication

sleeve gastrectomy on bougie 42 without plication

Group Type ACTIVE_COMPARATOR

sleeve with plication

Intervention Type PROCEDURE

sleeve with plication

Interventions

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sleeve with plication

Intervention Type PROCEDURE

sleeve without plication

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No