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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
History of Changes

January 27, 2009
June 7, 2010
April 2008
April 2009   (final data collection date for primary outcome measure)
Incidence of ileus [ Time Frame: Until ileus formation or first flatus post-op ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831246 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of Ileus After Gynecologic Surgery Using Chewing Gum
Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum

This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Ileus
  • 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.
  • Other: Standard Post-Op Care
    Patients are given standard post-op care with clear liquid diet as tolerated.
  • Experimental: 1
    Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.
    Intervention: Other: chewing gum - Extra Winterfresh
  • Sham Comparator: 2
    Patients are given standard post-op care with clear liquid diet as tolerated .
    Intervention: Other: Standard Post-Op Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00831246
2008.03.27.E2, 2008 JMC
No
James Clark, MD, Aultman Health Foundation
Aultman Health Foundation
Not Provided
Study Chair: Michael Hopkins, MD Aultman Health Foundation
Principal Investigator: James M Clark, MD Aultman Health Foundation
Aultman Health Foundation
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP