Nicotine Gum Recovery After Colorectal Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.

Detailed Description
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The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.

Official Title
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Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?

Conditions
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Post-operative Ileus

Intervention / Treatment
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* Drug: Nicotine gum
* Other: Regular chewing gum


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; Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy; Exclusion Criteria: Prior intestinal surgery 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 Pregnant women Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than 3 months ago. Patients requiring postoperative ventilation, pressor requirement or ICU stay Patients with prior cardiovascular disorders

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine gum<br>100 subjects who will actually get the intervention medication | Drug: Nicotine gum<br>* Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first<br>* Other names: Nicorrete gum;|
| Sham Comparator: regular chewing gum<br>100 subjects who will be part of a control group | Other: Regular chewing gum<br>* Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first<br>* Other names: Sugarlees chewing gum;|
| No Intervention: No gum<br>100 subjects who will not get neither the intervention nor the placebo gum. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Function Recovery | Time to first bowel movement or flatus | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Stay | Length of postoperative hospital stay | 30 days | 
| Post-operative Vomiting | Episodes of vomiting | 30 days | 
| Use of NG Tubes | Nasogastric tube (re)insertions | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ILEUS