Nicotine Gum Recovery After Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01662115
Recruitment Status : Terminated (Study has been terminated due linability to recruit the targeted participants. Aimed for 300 participants and only 4 were enrolled after 1 year.)
First Posted : August 10, 2012
Results First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Eric Weiss, The Cleveland Clinic

August 7, 2012
August 10, 2012
April 13, 2017
August 22, 2017
August 22, 2017
August 2012
June 2014   (Final data collection date for primary outcome measure)
Bowel Function Recovery [ Time Frame: 7 days ]
Time to first bowel movement or flatus
Same as current
Complete list of historical versions of study NCT01662115 on Archive Site
  • 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
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.
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (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 Identifier (NCT Number) in Medline.
June 2014
June 2014   (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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: No
Eric Weiss, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: ERIC G WEISS, MD Cleveland Clinic Florida
The Cleveland Clinic
August 2017

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