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

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Laparoscopic internal gastric banding; Procedure: laparoscopic sleeve gastrectomy

• Registration Number: NCT02878525
• Lead Sponsor: Minia University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-08-21
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-25
• Study Start: 2016-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic internal gastric banding	Laparoscopic internal gastric banding	Laparoscopic internal gastric banding
Laparoscopic sleeve gastrectomy	laparoscopic sleeve gastrectomy	Laparoscopic sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
safety of the technique	4 weeks	the incidence of introperative and early postoperative complications

Secondary Outcome Measures

Name	Time	Method
Hospital stay	30 days	Time of hospital stay
Metabolic effect	6-12 months	Effect of the procedure on blood sugar, serum lipid and hypertension
operative time	12 hours	the operative time from skin to skin
total cost	16 weeks	the total cost of the technique by US dollar and its early complications

Trial Locations

Locations (2)

Faculty of medicine; 🇪🇬 Minya, Egypt

Minia university hospital; 🇪🇬 Minya, Egypt