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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01559662
Enrollment
114
Registered
2012-03-21
Start date
2010-08-31
Completion date
2012-03-31
Last updated
2012-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTSugared Chewing Gum (Juicy Fruit)

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

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time (in hours) to tolerating a low residue diet30 day postoperative periodTime measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours

Secondary

MeasureTime frameDescription
Time (hours) to first bowel movement30 day postoperative periodTime (hours) from end of operation to first bowel movement
Daily Appetite AssessmentPostoperative day 1 - 7Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be)
Daily pain assessmentPostoperative day 1 - 7Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)
Time (in hours) to passage of flatus30 day postoperative periodTime from end of operation to first passage of flatus (reported by patient)
Major or Minor Medical and Surgical Complications30 day postoperative period
Length of postoperative hospitalization in daysDuration of postoperative hospitalization (expected average of 5 days)
Daily nausea assessmentPostoperative day 1 - 7Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026