Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

Not Applicable

Completed

• Conditions: Obesity, Morbid

• Registration Number: NCT05591833
• Lead Sponsor: Minia University

Brief Summary

to compare the results of SASI to SAS-J in treatment of morbid obesity

Detailed Description

200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J

Study Timeline

• Study First Submitted: 2022-05-07
• Study Start: 2022-07-01
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-20
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
nutritional deficiency	12 months	the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL)

Secondary Outcome Measures

Name	Time	Method
comorbidities	1 year	change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer
complications	1 year	early and late complications
weight loss	12 months	the effect of the 2 procedures on weight measured by percentage of excess weight loss

Trial Locations

Locations (1)

Minia university hospital; 🇪🇬 Minya, Egypt