Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

Sponsor

Aultman Health Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00831246

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

33.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.

Condition or Disease	Intervention/Treatment	Phase
Ileus	Other: chewing gum - Extra Winterfresh Other: Standard Post-Op Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Incidence of ileus [Until ileus formation or first flatus post-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aultman Health Foundation

ClinicalTrials.gov Identifier:

NCT00831246

Other Study ID Numbers:

2008.03.27.E2
2008 JMC

First Posted:

Jan 28, 2009

Last Update Posted:

Aug 21, 2018

Last Verified:

Aug 1, 2018

Keywords provided by Aultman Health Foundation

Additional relevant MeSH terms:

Ileus

Study Results

No Results Posted as of Aug 21, 2018