Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure

February 25, 2022 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures

single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Study Type

Interventional

Enrollment (Actual)

43

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 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
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAS-J
single anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures
Procedure: SAS-J
Single Anastomosis Sleeve Jejunal Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 rate of improved co morbidity
Time Frame: 12 months

the effect of the operation on co morbidity like diabetes and hypertension

the effect of the operation on co morbidity like diabetes and hypertension the effect of single anastomosis sleeve jejunal bypass of comorbidities
12 months
the incidence of nutritional deficiency
Time Frame: 12-24 months

the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.

the incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition
12-24 months
the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications
Time Frame: 12-24 months

early operative complications like leak, bleeding

complications like leak, bleeding, dumping,
12-24 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)

January 12, 2017

Primary Completion (Actual)

December 8, 2020

Study Completion (Actual)

January 4, 2021

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ac.med.21.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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