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

NCT01559662 | Completed

• 1 other identifier: CSMCGumStudy
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Keywords

chewing gum; ileus; gastrointestinal function; colorectal surgery; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Time (in hours) to passage of flatus

  30 day postoperative period

• Time (hours) to first bowel movement

  30 day postoperative period

• Daily Appetite Assessment

  Postoperative day 1 - 7

• Daily pain assessment

  Postoperative day 1 - 7

• Daily nausea assessment

  Postoperative day 1 - 7

Study Arms (2)

Sugared Chewing Gum

EXPERIMENTAL

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)

No Gum

NO INTERVENTION

No gum given, routine postoperative care provided

Interventions

Sugared Chewing Gum (Juicy Fruit) DIETARY_SUPPLEMENT

One stick of gum, 3 times daily from Postoperative day 1 to 7

Sugared Chewing Gum

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Phillip Fleshner, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal investigator

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 21, 2012
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

US (1)