Nicotine Gum Recovery After Colorectal Surgery

Phase 4

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nicotine gum	Nicotine gum	100 subjects who will actually get the intervention medication
regular chewing gum	Regular chewing gum	100 subjects who will be part of a control group

Primary Outcome Measures

Name	Time	Method
Bowel Function Recovery	7 days	Time to first bowel movement or flatus

Secondary Outcome Measures

Name	Time	Method
Post-operative Vomiting	30 days	Episodes of vomiting
Use of NG Tubes	30 days	Nasogastric tube (re)insertions
Hospital Stay	30 days	Length of postoperative hospital stay