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

NCT ID: NCT01559662

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Ileus

Keywords

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chewing gum ileus gastrointestinal function colorectal surgery abdominal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sugared Chewing Gum

Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time

Group Type EXPERIMENTAL

Sugared Chewing Gum (Juicy Fruit)

Intervention Type DIETARY_SUPPLEMENT

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

No Gum

No gum given, routine postoperative care provided

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sugared Chewing Gum (Juicy Fruit)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Phillip Fleshner MD

Pricipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Phillip Fleshner, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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CSMCGumStudy

Identifier Type: -

Identifier Source: org_study_id