Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy

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Detailed Description

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In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Laparoscopic internal gastric banding

Group Type EXPERIMENTAL

Laparoscopic internal gastric banding

Intervention Type PROCEDURE

Laparoscopic internal gastric banding

Laparoscopic sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

laparoscopic sleeve gastrectomy

Interventions

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Laparoscopic internal gastric banding

Intervention Type PROCEDURE

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* Approval to share in the study
* Patients fit for laparoscopic surgery

Exclusion Criteria

* Patient age less than 18 or more than 50 years old
* Refusal to share in the study
* Unfit for surgery
* patients with gastroesophageal reflux disease clinically or by investigation

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No