Laparoscopic Natural Gastric Banding for Morbid Obesity

July 29, 2023 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Laparoscopic Natural Gastric Banding for Management of Morbid Obesity

to do gastric banding using round ligament or omental flap instead of synesthetic band

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon

Study Type

Interventional

Enrollment (Estimated)

100

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
        • Recruiting
        • Minia University Hospital
        • Contact:
      • Minya, Egypt, 61511
        • Recruiting
        • Faculty of medicine
        • Contact:
        • Contact:
          • M

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

  • Adult

Accepts Healthy Volunteers

No

Description

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
  • previous restrictive bariatric procedure

Exclusion Criteria:

  • 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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gastric band
to do gastric banding use either round ligament or omental flap
Procedure: gastric band
gastric band
Active Comparator: sleeve gastrectomy
to do sleeve gastrectomy as standard
Procedure: gastric band
gastric band

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%EWL
Time Frame: 12 months
percentage of excess weight loss at one year
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications rate
Time Frame: 12 months
the incidence of complications
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 (Actual)

July 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 11, 2023

First Submitted That Met QC Criteria

June 11, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med 23.25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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