Naturally Banded Sleeve Gastrectomy

April 11, 2024 updated by: Alaa Mstafa Hassan Sewefy, Minia University
the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the idea is to use an omental flap or round ligament as a natural band in stead of synesthetic band in bariatric procedures, mainly gastric sleeve

Study Type

Interventional

Enrollment (Actual)

80

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
        • 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

14 years to 56 years (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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LSG
just laparoscopic sleeve gastrectomy without banding
Procedure: LSG
just to do sleeve gastrectomy
Experimental: LSG with omental band
laparoscopic sleeve gastrectomy with omental banding
Procedure: LSG with omental band
LSG with omental band

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect on weight loss
Time Frame: 12 months
the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI
12 months
the size of gastric pouch at one year
Time Frame: 12 months
the size of gastric pouch after sleeve gastrectomy in cc at one year using gastric volumetric study
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect on comorbidities
Time Frame: 12 monthts
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
12 monthts
operative time
Time Frame: 6 hours
operative time in minutes from skin incision to skin closure
6 hours
the incidences of complications
Time Frame: 12 monthss
the incidences of complications including early complication like leak and bleeding and late complications like stricture diagnosed by vomiting's and imaging and GERD dignosed by symptoms and endoscopy
12 monthss

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)

November 1, 2022

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

February 20, 2024

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

October 28, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med 22.33

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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