Back to resultsTwo or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic sleeve gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
- morbid obese patients
Exclusion Criteria:
- contraindication to laparoscopy
Sites / Locations
- Gastroenterology Surgical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2 cm from pylorus
6 cm from pylorus
Arm Description
at laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus.
at laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus
Outcomes
Primary Outcome Measures
percentage of excess weight loss
Secondary Outcome Measures
complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01846637
Brief Title
Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy
Official Title
Comparative Study Between Two and Five cm Resection During Laparoscopic Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
5. Study Description
Brief Summary
The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2 cm from pylorus
Arm Type
Experimental
Arm Description
at laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus.
Arm Title
6 cm from pylorus
Arm Type
Active Comparator
Arm Description
at laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sleeve gastrectomy
Primary Outcome Measure Information:
Title
percentage of excess weight loss
Time Frame
2 years
Secondary Outcome Measure Information:
Title
complications
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
improvement of comorbidities
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
morbid obese patients
Exclusion Criteria:
contraindication to laparoscopy
Facility Information:
Facility Name
Gastroenterology Surgical Center
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
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Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy
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