Single Anastomosis Sleeve Jejunal (SAS-J) Bypass

Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A Treatment for Morbid Obesity

The purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass

Detailed Description

in this study the investigators aim to test a new technique ( single anastomoses sleeve jejunal as a treatment for morbid obesity Which is a modification of Single anastomoses sleeve ileal bypass with short biliary limb ( about one third of the small intestine from the Duodeno-jejunal junction

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61511
    • Minia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• obese patients with BMI more than 40
• 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 50
• patients with BMI less than 50
• patient with previous upper abdominal surgery either for obesity or other diseases
• patients with preoperative GERD clinically or by investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass; Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid	Procedure: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass; Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	the operative time from skin incision to skin closure	the 1st 24 hours
intraoperative complications	intraoperative complications like bleeding, other organs injuries	the 1st 24 hours
the postoperative weight loss	the percentage of weight loss from total excess body weight	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect on metabolic syndrome if present	effect on blood sugar level, blood pressure and blood cholesterol level	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative biliary reflux	the presence of postoperative biliary reflux clinically and by upper endoscopy	3 months

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Chair: Alaa M Sewefy, MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: fac.med.016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED