- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455739
Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations
May 27, 2015 updated by: enis ozkaya, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Effect of Gum Chewing on Intestinal Functions After Gynecologic Operations
The investigators aimed to assess whether postoperative gum chewing improve intestinal functions.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Zeynep Kamil
-
Contact:
- enis ozkaya, md
- Email: enokaya1979@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: chewing gum positive
chewing gum group will chew gum
|
postoperative gum chewing to improve gastrointestinal function
|
|
No Intervention: chewing gum negative
chewing gum group will not chew gum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastrointesitinal function
Time Frame: postoperative first 48 hours
|
Gastrointesitinal function will be assess by bowel sound for every 2 hours and time of flatulence will be recorded
|
postoperative first 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ateş Karateke, md, Zeynep Kamil
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
May 20, 2015
First Submitted That Met QC Criteria
May 27, 2015
First Posted (Estimate)
May 28, 2015
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZEYNEP KAMIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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