Back to resultsEffect of Drainage on Laparoscopic Gastric Bypass Surgery
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drainage
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring Obesity, VAS, Pain, Laparoscopy, Bypass
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) were excluded
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DRAIN PLACEMENT
DRAIN NOT PLACED
Arm Description
Effects of drainage
Effects of not using drain
Outcomes
Primary Outcome Measures
3-Item Pain Intensity measyre (P3)
self reported pain intensity morning, second day and third day. Each item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03231423
Brief Title
Effect of Drainage on Laparoscopic Gastric Bypass Surgery
Official Title
Effect of Drain Usage on Patient Comfort on Laparoscopic Gastric Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 9, 2016 (Actual)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
June 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
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 is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.
Detailed Description
Question the necessity of routine use of drain in RYGB surgeon
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Obesity, VAS, Pain, Laparoscopy, Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DRAIN PLACEMENT
Arm Type
Experimental
Arm Description
Effects of drainage
Arm Title
DRAIN NOT PLACED
Arm Type
No Intervention
Arm Description
Effects of not using drain
Intervention Type
Other
Intervention Name(s)
Drainage
Intervention Description
Using drain after operation
Primary Outcome Measure Information:
Title
3-Item Pain Intensity measyre (P3)
Description
self reported pain intensity morning, second day and third day. Each item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)
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) were excluded
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Drainage on Laparoscopic Gastric Bypass Surgery
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