Back to resultsSingle Anastomosis Sleeve Jejunal (SAS-J) Bypass
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- Minia university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Arm Description
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid
Outcomes
Primary Outcome Measures
operative time
the operative time from skin incision to skin closure
intraoperative complications
intraoperative complications like bleeding, other organs injuries
the postoperative weight loss
the percentage of weight loss from total excess body weight
Secondary Outcome Measures
effect on metabolic syndrome if present
effect on blood sugar level, blood pressure and blood cholesterol level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02870530
Brief Title
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Official Title
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A Treatment for Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Arm Type
Experimental
Arm Description
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid
Intervention Type
Procedure
Intervention Name(s)
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
Intervention Description
Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid
Primary Outcome Measure Information:
Title
operative time
Description
the operative time from skin incision to skin closure
Time Frame
the 1st 24 hours
Title
intraoperative complications
Description
intraoperative complications like bleeding, other organs injuries
Time Frame
the 1st 24 hours
Title
the postoperative weight loss
Description
the percentage of weight loss from total excess body weight
Time Frame
12 month
Secondary Outcome Measure Information:
Title
effect on metabolic syndrome if present
Description
effect on blood sugar level, blood pressure and blood cholesterol level
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
postoperative biliary reflux
Description
the presence of postoperative biliary reflux clinically and by upper endoscopy
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M Sewefy, MD
Organizational Affiliation
Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.
Official's Role
Study Chair
Facility Information:
Facility Name
Minia university hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Single Anastomosis Sleeve Jejunal (SAS-J) Bypass
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