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

This study is currently recruiting participants.
Verified October 2012 by Allina Health System
Sponsor:
Information provided by (Responsible Party):
Allina Health System
ClinicalTrials.gov Identifier:
NCT01613274
First received: June 3, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colon Resection
 Other: gum chewing
Other: no gum chewing
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Gum Chewing on Bowel Motility in Post-operative Colon Resection Patients

Further study details as provided by Allina Health System:

Primary Outcome Measures:
  • Time to first flatus [ Time Frame: Every 4 hours following surgery until discharge, which is an average of 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first bowel movement [ Time Frame: Every 4 hours following surgery until discharge, which is an average of 5 days ] [ Designated as safety issue: No ]
  • Length of stay in days [ Time Frame: Patients will be followed until discharge, which is an average of 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
no gum chewing
 Other: no gum chewing
no gum chewing

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613274

Contacts
Contact: Julie A Sabo, MN 612-873-3364 julie.sabo@hcmed.org
Contact: Jody Leise, MSN 651-241-8342 jody.leise@allina.com

Locations
United States, Minnesota
United Hospital Recruiting
St Paul, Minnesota, United States, 55102
Contact: Julie A Sabo, MN     612-873-3364        
Principal Investigator: Julie A Sabo, RN MN CNS-BC            
Sponsors and Collaborators
Allina Health System
Investigators
Principal Investigator: Julie A Sabo, RN Mn CNS-BC United Hospital
  More Information

No publications provided

Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT01613274     History of Changes
Other Study ID Numbers: GCBM
Study First Received: June 3, 2012
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Allina Health System:
colon resection

ClinicalTrials.gov processed this record on May 19, 2013