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Completed

NCT Number: NCT01559662

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

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.

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Key information

Conditions

Postoperative Ileus Digestive System Diseases Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugared Chewing Gum (Juicy Fruit)

Dietary Supplement

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

Primary outcomes

  1. Time (in hours) to tolerating a low residue diet

    Time frame: 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 outcomes

  1. Time (in hours) to passage of flatus

    Time frame: 30 day postoperative period

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

  2. Time (hours) to first bowel movement

    Time frame: 30 day postoperative period

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

  3. Daily Appetite Assessment

    Time frame: Postoperative day 1 - 7

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

  4. Daily pain assessment

    Time frame: Postoperative day 1 - 7

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

  5. Daily nausea assessment

    Time frame: Postoperative day 1 - 7

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

  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)

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 21, 2012
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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