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

Not Applicable

Completed

• Conditions: Postoperative Ileus
• Interventions: Dietary Supplement: Sugared Chewing Gum (Juicy Fruit)

• Registration Number: NCT01559662
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-21
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-14
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugared Chewing Gum	Sugared Chewing Gum (Juicy Fruit)	Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time

Primary Outcome Measures

Name	Time	Method
Time (in hours) to tolerating a low residue diet	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

Name	Time	Method
Time (in hours) to passage of flatus	30 day postoperative period	Time from end of operation to first passage of flatus (reported by patient)
Daily Appetite Assessment	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	Postoperative day 1 - 7	Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)
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	Time (hours) from end of operation to first bowel movement
Daily nausea assessment	Postoperative day 1 - 7	Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States