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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
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: 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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Obstruction

ClinicalTrials.gov processed this record on November 25, 2014