Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

March 1, 2024 updated by: Alaa Mstafa Hassan Sewefy, Minia University
to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

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
  • Older 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

Exclusion Criteria:

  • patients refused to share in the study
  • patients unfit for surgery
  • patients aged less than 18 and older than 65
  • patient with previous upper abdominal surgery either for obesity or other diseases
  • revisional bariatric procedures

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: natural band
to use an round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
Procedure: natural band
to use the round ligament as a natural band in stead of synesthetic band with sleeve gastrectomy
Active Comparator: silicone band
to use a synesthetic band with sleeve gastrectomy
Procedure: silicone band
to use synesthetic band with sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total cost
Time Frame: 12 hours
total operative cost in Egyptian pound (LE)
12 hours
food intolerance
Time Frame: 1 year
food intolerance at one year food tolerance arabic score questionnaire
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%EWL
Time Frame: 1 year
percentage of weight loss at one year measured as (initial weight - follow-up weight) / (initial weight - bodyweight at a BMI of 25 kg/ m2) x 100
1 year
complications rate
Time Frame: 1 year
the incidence of early and late complications according to Clavien-Dindo (CD)
1 year
improvement of comorbidities
Time Frame: 1 year
the incidence of improvement of comorbidities
1 year

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 (Estimated)

March 15, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med.24.9

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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