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Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00831246
First Posted: January 28, 2009
Last Update Posted: June 8, 2010
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.
Information provided by:
Aultman Health Foundation
  Purpose
This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.

Condition Intervention
Ileus Other: chewing gum - Extra Winterfresh Other: Standard Post-Op Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum

Further study details as provided by Aultman Health Foundation:

Primary Outcome Measures:
  • Incidence of ileus [ Time Frame: Until ileus formation or first flatus post-op ]

Estimated Enrollment: 400
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.
Other: chewing gum - Extra Winterfresh
Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.
Sham Comparator: 2
Patients are given standard post-op care with clear liquid diet as tolerated .
Other: Standard Post-Op Care
Patients are given standard post-op care with clear liquid diet as tolerated.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All female patients 18 years of age or older undergoing surgery for any gynecologic procedure which the peritoneum is entered and general anesthesia is administered.
  • Disease State will not affect inclusion in the study. Women with previous surgeries or other medical conditions will be included as will those undergoing an initial operation.

Exclusion Criteria:

  • Patient deemed legally incompetent to sign their own consent
  • Women under the age of 18
  • Patients lacking their own or a false set of teeth
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00831246


Locations
United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Health Foundation
Investigators
Study Chair: Michael Hopkins, MD Aultman Health Foundation
Principal Investigator: James M Clark, MD Aultman Health Foundation
  More Information

Responsible Party: James Clark, MD, Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT00831246     History of Changes
Other Study ID Numbers: 2008.03.27.E2
2008 JMC
First Submitted: January 27, 2009
First Posted: January 28, 2009
Last Update Posted: June 8, 2010
Last Verified: June 2010

Keywords provided by Aultman Health Foundation:
Ileus,
Gynecologic surgery,
Post-operative,
Flatus

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases