Back to resultsSAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SAS-JB
OAGB
LSG
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 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
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
SAS-JB
MGB
LSG
Arm Description
laparoscopic single anastomosis sleeve jejunal bypass
laparoscopic mini gastric bypass
laparoscopic sleeve gastrectomy
Outcomes
Primary Outcome Measures
percentage of excess weight loss
percentage of excess weight loss in kilogram
Secondary Outcome Measures
the incidence of nutritional deficiency
the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
the rate of improved co morbidity
the effect of the operation on co morbidity like diabetes and hypertension
the incidence of early operative complications
early operative complications like leak, bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03821688
Brief Title
SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity
Official Title
Single Anastomosis Sleeve Jejunal Bypass Compared to One Anastomosis Gastric Bypass and Sleeve Gastrectomy as a Treatment for Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.
Detailed Description
150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities. the minimal follow up period is one year
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAS-JB
Arm Type
Experimental
Arm Description
laparoscopic single anastomosis sleeve jejunal bypass
Arm Title
MGB
Arm Type
Active Comparator
Arm Description
laparoscopic mini gastric bypass
Arm Title
LSG
Arm Type
Active Comparator
Arm Description
laparoscopic sleeve gastrectomy
Intervention Type
Procedure
Intervention Name(s)
SAS-JB
Intervention Description
single anastomosis sleeve jejunal bypass
Intervention Type
Procedure
Intervention Name(s)
OAGB
Intervention Description
one anastomosis gastric bypass
Intervention Type
Procedure
Intervention Name(s)
LSG
Intervention Description
laproscopic sleeve gastrectomy
Primary Outcome Measure Information:
Title
percentage of excess weight loss
Description
percentage of excess weight loss in kilogram
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the incidence of nutritional deficiency
Description
the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
Time Frame
2 years
Title
the rate of improved co morbidity
Description
the effect of the operation on co morbidity like diabetes and hypertension
Time Frame
2 years
Title
the incidence of early operative complications
Description
early operative complications like leak, bleeding
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M Sewefy, MD
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity
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