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

January 31, 2018 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Faculty of Medicine
      • Minya, Egypt, 61511
        • Minia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscopic internal gastric banding
Procedure: Laparoscopic internal gastric banding
Laparoscopic internal gastric banding
ACTIVE_COMPARATOR: Laparoscopic sleeve gastrectomy
Procedure: laparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of the technique
Time Frame: 4 weeks
the incidence of introperative and early postoperative complications
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (ESTIMATE)

August 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med.018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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