Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05591833
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Procedure: SASI; Procedure: SAS-J	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SASI	Procedure: SASI; Single-Anastomosis Sleeve ileal (SASI) Bypass
Experimental: SAS-J	Procedure: SAS-J; Single-Anastomosis Sleeve Jejunal (SAS-J) Bypass

Outcome Measures

Primary Outcome Measures

1. 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

1. comorbidities [1 year]

   change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer

2. complications [1 year]

   early and late complications

3. weight loss [12 months]

   the effect of the 2 procedures on weight measured by percentage of excess weight loss

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

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

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 and laparo-endoscopy, Minia University
• ClinicalTrials.gov Identifier: NCT05591833
• Other Study ID Numbers: fac.med 22.26
• First Posted: Oct 24, 2022
• Last Update Posted: Oct 24, 2022
• Last Verified: Oct 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: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Oct 24, 2022