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

Cedars-Sinai Medical Center1 site in 1 country114 target enrollmentAugust 2010

ConditionsPostoperative Ileus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postoperative Ileus
Sponsor: Cedars-Sinai Medical Center
Enrollment: 114
Locations: 1
Primary Endpoint: Time (in hours) to tolerating a low residue diet
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

March 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cedars-Sinai Medical Center

Responsible Party

Principal Investigator

Phillip Fleshner MD

Pricipal investigator

Cedars-Sinai Medical Center

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

Time (in hours) to passage of flatus(30 day postoperative period)
Daily Appetite Assessment(Postoperative day 1 - 7)
Daily pain assessment(Postoperative day 1 - 7)
Major or Minor Medical and Surgical Complications(30 day postoperative period)
Length of postoperative hospitalization in days(Duration of postoperative hospitalization (expected average of 5 days))
Time (hours) to first bowel movement(30 day postoperative period)
Daily nausea assessment(Postoperative day 1 - 7)