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

Postoperative Ileus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559662
• Other study ID #: CSMCGumStudy
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: August 14, 2012
• Start date: August 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Dietary Supplement:
• Sugared Chewing Gum (Juicy Fruit)
One stick of gum, 3 times daily from Postoperative day 1 to 7

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in hours) to tolerating a low residue diet	Time measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours	30 day postoperative period	No
Secondary	Time (in hours) to passage of flatus	Time from end of operation to first passage of flatus (reported by patient)	30 day postoperative period	No
Secondary	Time (hours) to first bowel movement	Time (hours) from end of operation to first bowel movement	30 day postoperative period	No
Secondary	Daily Appetite Assessment	Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be)	Postoperative day 1 - 7	No
Secondary	Daily pain assessment	Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)	Postoperative day 1 - 7	No
Secondary	Daily nausea assessment	Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)	Postoperative day 1 - 7	No
Secondary	Major or Minor Medical and Surgical Complications		30 day postoperative period	No
Secondary	Length of postoperative hospitalization in days		Duration of postoperative hospitalization (expected average of 5 days)	No