Back to resultsSingle Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single anastomosis sleeve jejunal bypass with hiatal repair
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
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 Type
Experimental
Arm Label
Single anastomosis sleeve jejunal bypass with hiatal repair
Arm Description
Single anastomosis sleeve jejunal bypass with hiatal repair
Outcomes
Primary Outcome Measures
the effect of sleeve jejunal bypass on reflux manifestations
evaluation of the effect of sleeve jejunal bypass on reflux manifestations
Secondary Outcome Measures
EWL
excess weight loss at one year
treatment of comorbidities
effect on obesity comorbidities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04823767
Brief Title
Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia
Official Title
Single Anastomosis Sleeve Iejenal Bypass With Crural Repair in Obese Patient With Hiatus Hernia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 15, 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 with hiatal repair for morbid obesity with reflux manifestations
Detailed Description
preoperative endoscopy was done and if hiatus hernia was present the patient is undergo single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations
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
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single anastomosis sleeve jejunal bypass with hiatal repair
Arm Type
Experimental
Arm Description
Single anastomosis sleeve jejunal bypass with hiatal repair
Intervention Type
Other
Intervention Name(s)
Single anastomosis sleeve jejunal bypass with hiatal repair
Intervention Description
Single anastomosis sleeve jejunal bypass with hiatal repair
Primary Outcome Measure Information:
Title
the effect of sleeve jejunal bypass on reflux manifestations
Description
evaluation of the effect of sleeve jejunal bypass on reflux manifestations
Time Frame
2 months
Secondary Outcome Measure Information:
Title
EWL
Description
excess weight loss at one year
Time Frame
one year
Title
treatment of comorbidities
Description
effect on obesity comorbidities
Time Frame
one year
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
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
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Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia
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