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Gum Chewing After Gynecologic Laparoscopy

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. Identifier: NCT01549353
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : December 4, 2012
Information provided by (Responsible Party):
Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee

Brief Summary:
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.

Condition or disease Intervention/treatment
Postoperative Care Behavioral: gum chewing

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?
Study Start Date : July 2011
Primary Completion Date : August 2012
Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: chewing gum Behavioral: gum chewing

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)

  2. 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,...)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01549353

Klinikum Klagenfurt am Woerthersee
Klagenfurt, Carinthia, Austria, 9020
Sponsors and Collaborators
Klinikum Klagenfurt am Wörthersee

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Husslein Heinrich, MD, Principal investigator, Klinikum Klagenfurt am Wörthersee Identifier: NCT01549353     History of Changes
Other Study ID Numbers: A 02/10
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012