Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure

Sponsor
Minia University (Other)
Overall Status
Completed
CT.gov ID
NCT05269420
Collaborator
(none)
43
1
1
47.7
0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: SAS-J
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures
Actual Study Start Date :
Jan 12, 2017
Actual Primary Completion Date :
Dec 8, 2020
Actual Study Completion Date :
Jan 4, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. weight loss [12 months]

    percentage of excess weight loss in kilogram

Secondary Outcome Measures

  1. the rate of improved co morbidity [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

  2. the incidence of nutritional deficiency [12-24 months]

    the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia. the incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition

  3. the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications [12-24 months]

    early operative complications like leak, bleeding complications like leak, bleeding, dumping,

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minia university hospital Minya Egypt 61511

Sponsors and Collaborators

  • Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alaa Mstafa Hassan Sewefy, Assistant professor & consultant of general surgery, Department of Surgery, Minia University
ClinicalTrials.gov Identifier:
NCT05269420
Other Study ID Numbers:
  • ac.med.21.23
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022