Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease

January 13, 2024 updated by: Alaa Mstafa Hassan Sewefy, Minia University
in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

in this study the patients that have morbid obesity concomitant GERD will managed by sleeve gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around the gastroesophageal junction

Study Type

Interventional

Enrollment (Actual)

90

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

18 years to 65 years (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 60
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sleeve gastrectomy+ cruroplasty + omental rape
Procedure: sleeve gastrectomy+ cruroplasty+ omental rap
sleeve gastrectomy+ cruroplasty+ omental rap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effect on GERD
Time Frame: 6 months
change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
comorbidities
Time Frame: 12 months
change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
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)

October 12, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

October 1, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med 22.64

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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