Back to resultsBiliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
biliary limb as fixed length
biliary limb as a percentage from small intestine length
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring biliary limb length in bypass bariatric surgery
Eligibility Criteria
Inclusion Criteria:
- obese patients with BMI more than 40 or more than 35 with comorbidity
- 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 35
- patient with previous upper abdominal surgery either for obesity or other diseases
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
loop bypass with fixed biliary limb length
loop bypass with a biliary limb is a percentage of the small intestine
Arm Description
in all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature
in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length
Outcomes
Primary Outcome Measures
effect on weight loss
the effect on weight loss
effect on nutritional deficiency
the effect on nutritional deficiency
Secondary Outcome Measures
operative time
operative time from skin incision to skin closure
effect on obesity comorbidities
the effect on improvement of obesity related comorbidities
early complications
the operative and postoperative 30 days complications
late complications
the late reported complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04826055
Brief Title
Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
Official Title
tp Make the Length of the Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (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
in all loop bypass bariatric procedure (mini gastric bypass & single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length
Detailed Description
in all loop bypass bariatric procedure (mini gastric bypass & single anastomosis sleeve jejunal bypass), biliary limb is fixed length we count the length of small intestine and do it as a percentage from total small intestine length rather than fixed length
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
biliary limb length in bypass bariatric surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
loop bypass with fixed biliary limb length
Arm Type
Active Comparator
Arm Description
in all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature
Arm Title
loop bypass with a biliary limb is a percentage of the small intestine
Arm Type
Experimental
Arm Description
in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length
Intervention Type
Other
Intervention Name(s)
biliary limb as fixed length
Intervention Description
n all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature
Intervention Type
Other
Intervention Name(s)
biliary limb as a percentage from small intestine length
Intervention Description
in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length
Primary Outcome Measure Information:
Title
effect on weight loss
Description
the effect on weight loss
Time Frame
one year
Title
effect on nutritional deficiency
Description
the effect on nutritional deficiency
Time Frame
1 year
Secondary Outcome Measure Information:
Title
operative time
Description
operative time from skin incision to skin closure
Time Frame
6 hours
Title
effect on obesity comorbidities
Description
the effect on improvement of obesity related comorbidities
Time Frame
1 year
Title
early complications
Description
the operative and postoperative 30 days complications
Time Frame
30 days
Title
late complications
Description
the late reported complications
Time Frame
1 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 or more than 35 with comorbidity
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 35
patient with previous upper abdominal surgery either for obesity or other diseases
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
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