The Effect of Gum Chewing on Bowel Motility in Post-operative Colon Resection Patients

NCT ID: NCT01613274

Last Updated: 2014-04-22

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

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon resection surgery decrease the time to first flatus, bowel movement and length of stay in the hospital.

Detailed Description

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Post-operative colon resection patients experience decreased bowel motility, which may cause pain, nausea/ vomiting, impaired nutritional intake, and abdominal distention. Return of bowel function is a strong determinant in length of hospital stay. There are small studies that have shown that chewing gum post-operatively may enhance bowel motility thus minimizing complications and decreasing length of hospital stay. The purpose of this research study is to determine the effect of gum chewing on bowel motility as measured by time to first flatus, bowel movement and length of stay in patients following a colon resection.

Conditions

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Colon Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gum chewing

Chewing mint flavored sugarless gum for 10-20 minutes three times a day following colon resection.

Group Type EXPERIMENTAL

gum chewing

Intervention Type OTHER

gum chewing three times a day for up to 20 minutes

no gum chewing

no gum chewing

Group Type PLACEBO_COMPARATOR

no gum chewing

Intervention Type OTHER

no gum chewing

Interventions

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gum chewing

gum chewing three times a day for up to 20 minutes

Intervention Type OTHER

no gum chewing

no gum chewing

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Admitted to Unit 2600
2. Age 18-100 years of age
3. Alert and oriented
4. Post-operative open or laparoscopic colon resection
5. English speaking.

Exclusion Criteria

1. Confused, or with cognitive disabilities that render the patient unable to answer questions about bowel motility.
2. Admitted to any other unit except 2600
3. Use of an epidural catheter for pain control post-operatively
4. Documented history of irritable bowel syndrome
5. Colostomy (new or old)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allina Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie A Sabo, RN Mn CNS-BC

Role: PRINCIPAL_INVESTIGATOR

United Hospital

Locations

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United Hospital

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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GCBM

Identifier Type: -

Identifier Source: org_study_id

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