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Effect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phillip Fleshner MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01559662
First received: March 16, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.


Condition Intervention
Postoperative Ileus
 Dietary Supplement: Sugared Chewing Gum (Juicy Fruit)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery in Patients Managed With Early Enteral Feeding

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Time (in hours) to tolerating a low residue diet [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
    Time measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours


Secondary Outcome Measures:
  • Time (in hours) to passage of flatus [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
    Time from end of operation to first passage of flatus (reported by patient)

  • Time (hours) to first bowel movement [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
    Time (hours) from end of operation to first bowel movement

  • Daily Appetite Assessment [ Time Frame: Postoperative day 1 - 7 ] [ Designated as safety issue: No ]
    Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be)

  • Daily pain assessment [ Time Frame: Postoperative day 1 - 7 ] [ Designated as safety issue: No ]
    Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)

  • Daily nausea assessment [ Time Frame: Postoperative day 1 - 7 ] [ Designated as safety issue: No ]
    Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)

  • Major or Minor Medical and Surgical Complications [ Time Frame: 30 day postoperative period ] [ Designated as safety issue: No ]
  • Length of postoperative hospitalization in days [ Time Frame: Duration of postoperative hospitalization (expected average of 5 days) ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sugared Chewing Gum
Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time
 Dietary Supplement: Sugared Chewing Gum (Juicy Fruit)
One stick of gum, 3 times daily from Postoperative day 1 to 7
No Intervention: No Gum
No gum given, routine postoperative care provided

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
  • American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
  • Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy

Exclusion Criteria:

  • Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
  • American Society of Anesthesiologists (ASA) Class IV or V;
  • History of abdominal carcinomatosis
  • History of radiation enteritis
  • Children < 18 or adults > 85 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559662

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Phillip Fleshner, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Phillip Fleshner MD, Pricipal investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01559662     History of Changes
Other Study ID Numbers: CSMCGumStudy
Study First Received: March 16, 2012
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
chewing gum
ileus
gastrointestinal function
colorectal surgery
abdominal surgery

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013