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

August 14, 2012 updated by: Phillip Fleshner MD, Cedars-Sinai Medical Center

A Prospective Randomized Controlled Trial of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery in Patients Managed With Early Enteral Feeding

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

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
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 day postoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 day postoperative period
Time (hours) to first bowel movement
Time Frame: 30 day postoperative period
Time (hours) from end of operation to first bowel movement
30 day postoperative period
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)
Postoperative day 1 - 7
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)
Postoperative day 1 - 7
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)
Postoperative day 1 - 7
Major or Minor Medical and Surgical Complications
Time Frame: 30 day postoperative period
30 day postoperative period
Length of postoperative hospitalization in days
Time Frame: Duration of postoperative hospitalization (expected average of 5 days)
Duration of postoperative hospitalization (expected average of 5 days)

Collaborators and Investigators

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

Sponsor

Cedars-Sinai Medical Center

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

August 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMCGumStudy

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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