Nicotine Gum Recovery After Colorectal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Cleveland Clinic Florida.
Recruitment status was  Recruiting
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

August 7, 2012
August 9, 2012
August 2012
December 2012   (final data collection date for primary outcome measure)
Bowel function recovery [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Time to first bowel movement or flatus
Same as current
Complete list of historical versions of study NCT01662115 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Nicotine Gum Recovery After Colorectal Surgery
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Post-operative Ileus
  • Drug: Nicotine gum
    Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
    Other Name: Nicorrete gum
  • 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
  • Active Comparator: Nicotine gum
    100 subjects who will actually get the intervention medication
    Intervention: Drug: Nicotine gum
  • Sham Comparator: regular chewing gum
    100 subjects who will be part of a control group
    Intervention: Other: Regular chewing gum
  • No Intervention: No gum
    100 subjects who will not get neither the intervention nor the placebo gum.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: KARLA ARANCIBIA, MD 954--659-5241 ARANCIK@ccf.org
Contact: Jorge Canedo, MD 954-659-5861 canedoj@ccf.org
United States
 
NCT01662115
CRS-2012-05
No
Eric Weiss, Cleveland Clinic Florida
Cleveland Clinic Florida
Not Provided
Principal Investigator: ERIC G WEISS, MD Cleveland Clinic Florida
Cleveland Clinic Florida
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP