Sleeve Gastrectomy with Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

February 28, 2025 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Sleeve Gastrectomy with Jejuno-ieal Bypass

sleeve gastrectomy with jejunoileal bypass (SGJIB) is a novel technique for the surgical treatment of obesity. The aim of the study is to compare this maneuver with single anastomosis sleeve jejunal bypass (SAS-JB)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

200 patients will be randomly divided into to equal . Group 1 will be operated by sleeve gastrectomy with jejunoileal bypass with the anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction. and group 2 will be operated by single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Recruiting
        • Faculty of medicine
        • Contact:
        • Contact:
          • M
        • Contact:
          • Alaa Sewefy, professor
        • Contact:
          • Taha Kayed, MD

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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGJIB
Procedure: SGJIB
sleeve gastrectomy with jejunoileal bypass with anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction.
Active Comparator: SAS-JB
Procedure: SAS-JB
single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stoma complications
Time Frame: one year
any complication due to sleeve jejunal anastomosis
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss at one year
Time Frame: one year
the effect of the 2 procedures on weight measured by percentage of excess weight loss
one year
improvement of comorbidities
Time Frame: one year
change in comorbidities
one year

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Principal Investigator: Alaa Sewefy, professor, Minia University, faculty of medicine
  • Study Director: Taha Kayed, MD, Minia University, faculty of medicine

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)

September 28, 2024

Primary Completion (Estimated)

October 20, 2025

Study Completion (Estimated)

November 20, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 27, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ac.med.24.34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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