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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allina Health System
ClinicalTrials.gov Identifier:
NCT01613274
First received: June 3, 2012
Last updated: April 21, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


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 ]

Enrollment: 80
Study Start Date: June 2012
Study Completion Date: April 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613274

Locations
United States, Minnesota
United Hospital
St Paul, Minnesota, United States, 55102
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: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Allina Health System:
colon resection

ClinicalTrials.gov processed this record on November 20, 2014