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Nicotine Gum Recovery After Colorectal Surgery

This study is currently recruiting participants.
Verified August 2012 by Cleveland Clinic Florida
Sponsor:
Information provided by (Responsible Party):
Eric Weiss, Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT01662115
First received: August 7, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • Bowel function recovery [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Time to first bowel movement or flatus


Secondary Outcome Measures:
  • Hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Length of postoperative hospital stay

  • Post-operative vomiting [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Episodes of vomiting

  • Use of NG Tubes [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Nasogastric tube (re)insertions


Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662115

Contacts
Contact: KARLA ARANCIBIA, MD 954--659-5241 ARANCIK@ccf.org
Contact: Jorge Canedo, MD 954-659-5861 canedoj@ccf.org

Locations
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: KARLA ARABACIAN, MD     954-659-5241     ARABACK@CCF.ORG    
Contact: Jorge CANEDO, MD     954-659-5861     CANEDOJ@CCF.ORG    
Principal Investigator: ERIC G WEISS, MD            
Sponsors and Collaborators
Cleveland Clinic Florida
Investigators
Principal Investigator: ERIC G WEISS, MD Cleveland Clinic Florida
  More Information

No publications provided

Responsible Party: Eric Weiss, DIO and Chairman of Graduate Medical Education at Cleveland Clinic Florida,, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT01662115     History of Changes
Other Study ID Numbers: CRS-2012-05
Study First Received: August 7, 2012
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Clinic Florida:
ILEUS

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013