Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

NCT ID: NCT00831246

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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Conditions

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Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

chewing gum - Extra Winterfresh

Intervention Type OTHER

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

2

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

Group Type SHAM_COMPARATOR

Standard Post-Op Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Standard Post-Op Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aultman Health Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Hopkins, MD

Role: STUDY_CHAIR

Aultman Health Foundation

James M Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Aultman Health Foundation

Locations

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Aultman Health Foundation

Canton, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2008 JMC

Identifier Type: -

Identifier Source: secondary_id

2008.03.27.E2

Identifier Type: -

Identifier Source: org_study_id

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