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

Study Overview
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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.

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

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Dietary Supplement: Sugared Chewing Gum (Juicy Fruit)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugared Chewing Gum<br>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)<br>* One stick of gum, 3 times daily from Postoperative day 1 to 7<br>|
| No Intervention: No Gum<br>No gum given, routine postoperative care provided | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (in hours) to passage of flatus | Time from end of operation to first passage of flatus (reported by patient) | 30 day postoperative period | 
| Time (hours) to first bowel movement | Time (hours) from end of operation to first bowel movement | 30 day postoperative period | 
| Daily Appetite Assessment | Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be) | Postoperative day 1 - 7 | 
| Daily pain assessment | Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be) | Postoperative day 1 - 7 | 
| Daily nausea assessment | Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be) | Postoperative day 1 - 7 | 
| Major or Minor Medical and Surgical Complications |  | 30 day postoperative period | 
| Length of postoperative hospitalization in days |  | Duration of postoperative hospitalization (expected average of 5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chewing gum, ileus, gastrointestinal function, colorectal surgery, abdominal surgery