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Nicotine Gum Recovery After Colorectal Surgery

This study has been completed.
Information provided by (Responsible Party):
Eric Weiss, Cleveland Clinic Florida Identifier:
First received: August 7, 2012
Last updated: December 11, 2015
Last verified: December 2015
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.

Condition Intervention Phase
Post-operative Ileus
Drug: Nicotine gum
Other: Regular chewing gum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?

Resource links provided by NLM:

Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • Bowel function recovery [ Time Frame: 7 days ]
    Time to first bowel movement or flatus

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: 30 days ]
    Length of postoperative hospital stay

  • Post-operative vomiting [ Time Frame: 30 days ]
    Episodes of vomiting

  • Use of NG Tubes [ Time Frame: 30 days ]
    Nasogastric tube (re)insertions

Enrollment: 7
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicotine gum
100 subjects who will actually get the intervention medication
Drug: Nicotine gum
Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
Other Name: Nicorrete gum
Sham Comparator: regular chewing gum
100 subjects who will be part of a control group
Other: Regular chewing gum
Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
Other Name: Sugarlees chewing gum
No Intervention: No gum
100 subjects who will not get neither the intervention nor the placebo gum.

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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01662115

United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Principal Investigator: ERIC G WEISS, MD Cleveland Clinic Florida
  More Information

Responsible Party: Eric Weiss, DIO and Chairman of Graduate Medical Education at Cleveland Clinic Florida,, Cleveland Clinic Florida Identifier: NCT01662115     History of Changes
Other Study ID Numbers: CRS-2012-05
Study First Received: August 7, 2012
Last Updated: December 11, 2015

Keywords provided by Cleveland Clinic Florida:

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017