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Nicotine Gum Recovery After Colorectal Surgery

This study has been terminated.
(Study has been terminated due linability to recruit the targeted participants. Aimed for 300 participants and only 4 were enrolled after 1 year.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662115
First Posted: August 10, 2012
Last Update Posted: August 22, 2017
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.
Information provided by (Responsible Party):
Eric Weiss, The Cleveland Clinic
  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
Intervention Model: Factorial Assignment
Masking: Single (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 Eric Weiss, The Cleveland Clinic:

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: 4
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662115


Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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,, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01662115     History of Changes
Other Study ID Numbers: CRS-2012-05
First Submitted: August 7, 2012
First Posted: August 10, 2012
Results First Submitted: April 13, 2017
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eric Weiss, The Cleveland Clinic:
ILEUS

Additional relevant MeSH terms:
Nicotine
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


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