Gum Chewing After Gynecologic Laparoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee
ClinicalTrials.gov Identifier:
NCT01549353
First received: February 23, 2012
Last updated: December 1, 2012
Last verified: December 2012
  Purpose

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 Intervention
Postoperative Care
Behavioral: gum chewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?

Further study details as provided by Klinikum Klagenfurt am Wörthersee:

Primary Outcome Measures:
  • Time to return to active bowel movements [ Time Frame: participants will be followed for the duration of hospital stay ] [ Designated as safety issue: No ]
    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:
  • patient satisfaction with postoperative gum chewing [ Time Frame: participants will be followed for the duration of the hospital stay ] [ Designated as safety issue: No ]
    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)

  • Number of participants with adverse events [ Time Frame: participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]
    All problems that are linked to postoperative gum chewing will be recorded (e.g. vomiting, aspiration,...)


Estimated Enrollment: 200
Study Start Date: July 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chewing gum Behavioral: gum chewing

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • loose teeth
  • chronic obstipation
  • laparotomy
  • operations longer then 3 h
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549353

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

No publications provided by Klinikum Klagenfurt am Wörthersee

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Husslein Heinrich, MD, Principal investigator, Klinikum Klagenfurt am Wörthersee
ClinicalTrials.gov Identifier: NCT01549353     History of Changes
Other Study ID Numbers: A 02/10
Study First Received: February 23, 2012
Last Updated: December 1, 2012
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on October 01, 2014