Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

August 18, 2018 updated by: Aultman Health Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of ileus
Time Frame: Until ileus formation or first flatus post-op
Until ileus formation or first flatus post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aultman Health Foundation

Investigators

  • Study Chair: Michael Hopkins, MD, Aultman Health Foundation
  • Principal Investigator: James M Clark, MD, Aultman Health Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (ESTIMATE)

January 28, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 18, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.03.27.E2
  • 2008 JMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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