Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

This study has been completed.
Sponsor:
Information provided by:
Aultman Health Foundation
ClinicalTrials.gov Identifier:
NCT00831246
First received: January 27, 2009
Last updated: June 7, 2010
Last verified: June 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 27, 2009
Last Updated: June 7, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 20, 2014