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Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

Primary Purpose

Ileus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chewing gum - Extra Winterfresh
Standard Post-Op Care
Sponsored by
Aultman Health Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ileus focused on measuring Ileus,, Gynecologic surgery,, Post-operative,, Flatus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Aultman Health Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.

Patients are given standard post-op care with clear liquid diet as tolerated .

Outcomes

Primary Outcome Measures

Incidence of ileus

Secondary Outcome Measures

Full Information

First Posted
January 27, 2009
Last Updated
August 18, 2018
Sponsor
Aultman Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00831246
Brief Title
Prevention of Ileus After Gynecologic Surgery Using Chewing Gum
Official Title
Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aultman Health Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
Ileus,, Gynecologic surgery,, Post-operative,, Flatus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Patients are given standard post-op care with clear liquid diet as tolerated .
Intervention Type
Other
Intervention Name(s)
chewing gum - Extra Winterfresh
Intervention Description
Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.
Intervention Type
Other
Intervention Name(s)
Standard Post-Op Care
Intervention Description
Patients are given standard post-op care with clear liquid diet as tolerated.
Primary Outcome Measure Information:
Title
Incidence of ileus
Time Frame
Until ileus formation or first flatus post-op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hopkins, MD
Organizational Affiliation
Aultman Health Foundation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James M Clark, MD
Organizational Affiliation
Aultman Health Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States

12. IPD Sharing Statement

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Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

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