Back to resultsSingle Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SAS-J
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid
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
- previous restrictive bariatric procedure
Exclusion Criteria:
- 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
Sites / Locations
- Minia university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAS-J
Arm Description
single anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures
Outcomes
Primary Outcome Measures
weight loss
percentage of excess weight loss in kilogram
Secondary Outcome Measures
the rate of improved co morbidity
the effect of the operation on co morbidity like diabetes and hypertension
the effect of the operation on co morbidity like diabetes and hypertension the effect of single anastomosis sleeve jejunal bypass of comorbidities
the incidence of nutritional deficiency
the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
the incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition
the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications
early operative complications like leak, bleeding
complications like leak, bleeding, dumping,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05269420
Brief Title
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure
Official Title
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
December 8, 2020 (Actual)
Study Completion Date
January 4, 2021 (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
single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band
Detailed Description
in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAS-J
Arm Type
Experimental
Arm Description
single anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures
Intervention Type
Procedure
Intervention Name(s)
SAS-J
Intervention Description
Single Anastomosis Sleeve Jejunal Bypass
Primary Outcome Measure Information:
Title
weight loss
Description
percentage of excess weight loss in kilogram
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the rate of improved co morbidity
Description
the effect of the operation on co morbidity like diabetes and hypertension
the effect of the operation on co morbidity like diabetes and hypertension the effect of single anastomosis sleeve jejunal bypass of comorbidities
Time Frame
12 months
Title
the incidence of nutritional deficiency
Description
the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia.
the incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition
Time Frame
12-24 months
Title
the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications
Description
early operative complications like leak, bleeding
complications like leak, bleeding, dumping,
Time Frame
12-24 months
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
previous restrictive bariatric procedure
Exclusion Criteria:
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
Facility Information:
Facility Name
Minia university hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure
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