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

April 21, 2014 updated by: Allina Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

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
    • Minnesota
      • St Paul, Minnesota, United States, 55102
        • United Hospital

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

All

Description

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)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gum chewing
Chewing mint flavored sugarless gum for 10-20 minutes three times a day following colon resection.
Other: gum chewing
gum chewing three times a day for up to 20 minutes
Placebo Comparator: no gum chewing
Other: no gum chewing
no gum chewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first flatus
Time Frame: Every 4 hours following surgery until discharge, which is an average of 5 days
Every 4 hours following surgery until discharge, which is an average of 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first bowel movement
Time Frame: Every 4 hours following surgery until discharge, which is an average of 5 days
Every 4 hours following surgery until discharge, which is an average of 5 days
Length of stay in days
Time Frame: Patients will be followed until discharge, which is an average of 5 days
Patients will be followed until discharge, which is an average of 5 days

Collaborators and Investigators

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

Sponsor

Allina Health System

Investigators

  • Principal Investigator: Julie A Sabo, RN Mn CNS-BC, United Hospital

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

June 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 3, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimate)

June 7, 2012

Study Record Updates

Last Update Posted (Estimate)

April 22, 2014

Last Update Submitted That Met QC Criteria

April 21, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GCBM

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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