Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269420
• Other study ID #: ac.med.21.23
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: January 4, 2021

Study information

• Verified date: February 2022
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 4, 2021
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• SAS-J
Single Anastomosis Sleeve Jejunal Bypass

Locations

Country	Name	City	State
Egypt	Minia university hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	percentage of excess weight loss in kilogram	12 months
Secondary	the rate of improved co morbidity	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
Secondary	the incidence of nutritional deficiency	the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.; the incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition	12-24 months
Secondary	the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications	early operative complications like leak, bleeding; complications like leak, bleeding, dumping,	12-24 months