We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559662
First Posted: March 21, 2012
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Phillip Fleshner MD, Cedars-Sinai Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 Phillip Fleshner MD, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Time (in hours) to tolerating a low residue diet [ Time Frame: 30 day postoperative period ]
    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 ]
    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 ]
    Time (hours) from end of operation to first bowel movement

  • Daily Appetite Assessment [ Time Frame: Postoperative day 1 - 7 ]
    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 ]
    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 ]
    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 ]
  • Length of postoperative hospitalization in days [ Time Frame: Duration of postoperative hospitalization (expected average of 5 days) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Phillip Fleshner MD, Pricipal investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01559662     History of Changes
Other Study ID Numbers: CSMCGumStudy
First Submitted: March 16, 2012
First Posted: March 21, 2012
Last Update Posted: August 15, 2012
Last Verified: August 2012

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