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CompletedNCT01559662Updated Aug 15, 2012

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

An interventional study of Sugared Chewing Gum (Juicy Fruit) in Postoperative Ileus, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-08-15.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Ileus

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Keywords

  • chewing gum
  • ileus
  • gastrointestinal function
  • colorectal surgery
  • abdominal surgery
03

In context

Ileus

124 studies on the registry are indexed under Ileus; 12 are open to participants now.

This study's enrollment of 114 is above the median of 97 across 106 interventional studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    Sugared Chewing Gum

    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 intervention
    No Gum

    No gum given, routine postoperative care provided

Interventions

  • Dietary supplementSugared Chewing Gum (Juicy Fruit)

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

06

What researchers measure

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

    Time frame: 30 day postoperative period

Secondary outcomes

  1. Time (in hours) to passage of flatus

    Time from end of operation to first passage of flatus (reported by patient)

    Time frame: 30 day postoperative period

  2. Time (hours) to first bowel movement

    Time (hours) from end of operation to first bowel movement

    Time frame: 30 day postoperative period

  3. Daily Appetite Assessment

    Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be)

    Time frame: Postoperative day 1 - 7

  4. Daily pain assessment

    Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)

    Time frame: Postoperative day 1 - 7

  5. Daily nausea assessment

    Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)

    Time frame: Postoperative day 1 - 7

  6. Major or Minor Medical and Surgical Complications

    Time frame: 30 day postoperative period

  7. Length of postoperative hospitalization in days

    Time frame: Duration of postoperative hospitalization (expected average of 5 days)

07

Study locations

1 site
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01559662
Lead sponsor
Cedars-Sinai Medical Center
Responsible party
Phillip Fleshner MD (Pricipal investigator, Cedars-Sinai Medical Center) — Principal investigator
First posted
Mar 21, 2012
Start date
Aug 2010
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Aug 15, 2012

Study contacts

Phillip Fleshner, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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