SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity

December 26, 2021 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Single Anastomosis Sleeve Jejunal Bypass Compared to One Anastomosis Gastric Bypass and Sleeve Gastrectomy as a Treatment for Morbid Obesity

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities. the minimal follow up period is one year

Study Type

Interventional

Enrollment (Actual)

210

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
        • Faculty of Medicine

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAS-JB
laparoscopic single anastomosis sleeve jejunal bypass
Procedure: SAS-JB
single anastomosis sleeve jejunal bypass
Active Comparator: MGB
laparoscopic mini gastric bypass
Procedure: OAGB
one anastomosis gastric bypass
Active Comparator: LSG
laparoscopic sleeve gastrectomy
Procedure: LSG
laproscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of excess weight loss
Time Frame: 12 months
percentage of excess weight loss in kilogram
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of nutritional deficiency
Time Frame: 2 years
the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
2 years
the rate of improved co morbidity
Time Frame: 2 years
the effect of the operation on co morbidity like diabetes and hypertension
2 years
the incidence of early operative complications
Time Frame: one month
early operative complications like leak, bleeding
one month

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)

March 15, 2019

Primary Completion (Actual)

August 10, 2020

Study Completion (Actual)

August 10, 2020

Study Registration Dates

First Submitted

January 19, 2019

First Submitted That Met QC Criteria

January 26, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 26, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med.047

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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