Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

Obesity, Morbid Clinical Trial

Official title:

Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591833
• Other study ID #: fac.med 22.26
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 20, 2023

Study information

• Verified date: September 2023
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 20, 2023
• Est. primary completion date: September 1, 2023
• 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

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• SASI
Single-Anastomosis Sleeve ileal (SASI) Bypass
• SAS-J
Single-Anastomosis Sleeve Jejunal (SAS-J) 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	nutritional deficiency	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)	12 months
Secondary	comorbidities	change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer	1 year
Secondary	complications	early and late complications	1 year
Secondary	weight loss	the effect of the 2 procedures on weight measured by percentage of excess weight loss	12 months