Back to resultsStandard Sleeve Pouch Versus Relatively Wide Pouch With Plication
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sleeve with plication
sleeve without plication
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring post sleeve gastrectomy leak, post sleeve gastrectomy
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
- Minya university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sleeve without plication
sleeve with plication
Arm Description
sleeve gastrectomy on bougie 36 without plication
sleeve gastrectomy on bougie 42 without plication
Outcomes
Primary Outcome Measures
the incidence of postoperative stable line bleeding
early postoperative bleeding from stable line
the incidence of stable line leakage
leak from stable line
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04144361
Brief Title
Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
Official Title
Outcomes of Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
August 20, 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
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding
Detailed Description
three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group A : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group B: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
post sleeve gastrectomy leak, post sleeve gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sleeve without plication
Arm Type
Experimental
Arm Description
sleeve gastrectomy on bougie 36 without plication
Arm Title
sleeve with plication
Arm Type
Active Comparator
Arm Description
sleeve gastrectomy on bougie 42 without plication
Intervention Type
Procedure
Intervention Name(s)
sleeve with plication
Intervention Description
sleeve with plication
Intervention Type
Procedure
Intervention Name(s)
sleeve without plication
Intervention Description
sleeve without plication
Primary Outcome Measure Information:
Title
the incidence of postoperative stable line bleeding
Description
early postoperative bleeding from stable line
Time Frame
2-24 hours
Title
the incidence of stable line leakage
Description
leak from stable line
Time Frame
1-30 days
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
Organizational Affiliation
Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
Facility Name
Minya university hospital
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
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Standard Sleeve Pouch Versus Relatively Wide Pouch With Plication
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