Nicotine Gum Recovery After Colorectal Surgery



Status:Terminated
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:8/23/2017
Start Date:August 2012
End Date:June 2014

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Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?

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.

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.

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
We found this trial at
1
site
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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from
Weston, FL
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