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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
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Disorder Postoperative focused on measuring intestinal function, chewing gum

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
May 20, 2015
Last Updated
May 27, 2015
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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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

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Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations

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