Gum Chewing After Gynecologic Laparoscopy

December 1, 2012 updated by: Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee

Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?

Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

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

  • Austria
    • Carinthia
      • Klagenfurt, Carinthia, Austria, 9020
        • Klinikum Klagenfurt am Woerthersee

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all gynecologic laparoscopic surgery
  • normal level of CA 125 postmenopausal

Exclusion Criteria:

  • loose teeth
  • chronic obstipation
  • laparotomy
  • operations longer then 3 h

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chewing gum
Behavioral: gum chewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to return to active bowel movements
Time Frame: participants will be followed for the duration of hospital stay
First active bowel movement is defined as time from operation until first passage of flatus. Time until first defecation will also be measured.
participants will be followed for the duration of hospital stay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction with postoperative gum chewing
Time Frame: participants will be followed for the duration of the hospital stay
Satisfaction will be measured with a visual analog scale (1 participant would never chew gum postoperatively again - 10 participant would always like to chew gum postoperatively)
participants will be followed for the duration of the hospital stay
Number of participants with adverse events
Time Frame: participants will be followed for the duration of hospital stay
All problems that are linked to postoperative gum chewing will be recorded (e.g. vomiting, aspiration,...)
participants will be followed for the duration of hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Klagenfurt am Wörthersee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 1, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • A 02/10

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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