Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations
Primary Purpose
Gastrointestinal Disorder Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
chewing gum
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Disorder Postoperative focused on measuring intestinal function, chewing gum
Eligibility Criteria
Inclusion Criteria:
- Women underwent gynecologic operation
- Women who are eligible for gum chewing
Exclusion Criteria:
- Women with previous gastrointestinal intervantion
- Women with previous abdominal surgery
Sites / Locations
- Zeynep KamilRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
chewing gum positive
chewing gum negative
Arm Description
chewing gum group will chew gum
chewing gum group will not chew gum
Outcomes
Primary Outcome Measures
Gastrointesitinal function
Gastrointesitinal function will be assess by bowel sound for every 2 hours and time of flatulence will be recorded
Secondary Outcome Measures
Full Information
NCT ID
NCT02455739
First Posted
May 20, 2015
Last Updated
May 27, 2015
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02455739
Brief Title
Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations
Official Title
Effect of Gum Chewing on Intestinal Functions After Gynecologic Operations
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators aimed to assess whether postoperative gum chewing improve intestinal functions.
Detailed Description
We will randomize patients into two groups after gynecologic operations. One group will chew gum, the other group not and we will assess the gastrointestinal function functions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disorder Postoperative
Keywords
intestinal function, chewing gum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chewing gum positive
Arm Type
Experimental
Arm Description
chewing gum group will chew gum
Arm Title
chewing gum negative
Arm Type
No Intervention
Arm Description
chewing gum group will not chew gum
Intervention Type
Other
Intervention Name(s)
chewing gum
Intervention Description
postoperative gum chewing to improve gastrointestinal function
Primary Outcome Measure Information:
Title
Gastrointesitinal function
Description
Gastrointesitinal function will be assess by bowel sound for every 2 hours and time of flatulence will be recorded
Time Frame
postoperative first 48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women underwent gynecologic operation
Women who are eligible for gum chewing
Exclusion Criteria:
Women with previous gastrointestinal intervantion
Women with previous abdominal surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
enis ozkaya, md
Phone
905054742459
Email
enozkaya1979@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Taylan şenol, md
Phone
905054037490
Email
taylan_senol@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ateş Karateke, md
Organizational Affiliation
Zeynep Kamil
Official's Role
Study Director
Facility Information:
Facility Name
Zeynep Kamil
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
enis ozkaya, md
Email
enokaya1979@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations
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