Back to resultsComparison of Stapler Line Bleeding Control Techniquessurgery
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Coutery
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid
Eligibility Criteria
Inclusion Criteria:
- Morbid obese patients
Exclusion Criteria:
- Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)
Sites / Locations
- Inonu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
coutery
clips
Arm Description
Stapler bloom will be stopped with cautery
Stapler bloom will be stopped with clipping
Outcomes
Primary Outcome Measures
3-item drainage control
Bleeding quantities to be noted
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03240367
Brief Title
Comparison of Stapler Line Bleeding Control Techniquessurgery
Official Title
Comparison of Stapler Line Bleeding Control Techniques in Laparoscopic Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 4, 2016 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ersin Gündoğan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.
Detailed Description
The question of the availability of cautery in RYGB surgeons
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
coutery
Arm Type
Experimental
Arm Description
Stapler bloom will be stopped with cautery
Arm Title
clips
Arm Type
No Intervention
Arm Description
Stapler bloom will be stopped with clipping
Intervention Type
Other
Intervention Name(s)
Coutery
Intervention Description
Stapler line bleeding control with coutery
Primary Outcome Measure Information:
Title
3-item drainage control
Description
Bleeding quantities to be noted
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Morbid obese patients
Exclusion Criteria:
Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ersin Gündoğan, MD
Organizational Affiliation
study principal investigator
Official's Role
Study Director
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44915
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Stapler Line Bleeding Control Techniquessurgery
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