Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Drainage on Laparoscopic Gastric Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231423
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ersin Gündoğan, Inonu University

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Other: Drainage Not Applicable

Detailed Description:
Question the necessity of routine use of drain in RYGB surgeon

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Drain Usage on Patient Comfort on Laparoscopic Gastric Bypass Surgery
Actual Study Start Date : December 9, 2016
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : June 22, 2017

Arm Intervention/treatment
Experimental: DRAIN PLACEMENT
Effects of drainage
Other: Drainage
Using drain after operation

No Intervention: DRAIN NOT PLACED
Effects of not using drain



Primary Outcome Measures :
  1. 3-Item Pain Intensity measyre (P3) [ Time Frame: 8 months ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Layout table for additonal information
Responsible Party: Ersin Gündoğan, Operator doctor, Inonu University
ClinicalTrials.gov Identifier: NCT03231423     History of Changes
Other Study ID Numbers: 2016/181
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ersin Gündoğan, Inonu University:
Obesity
VAS
Pain
Laparoscopy
Bypass
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms