Nicotine Gum Recovery After Colorectal Surgery

August 21, 2017 updated by: Eric Weiss, The Cleveland Clinic

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Sugarlees chewing gum
NO_INTERVENTION: No gum
100 subjects who will not get neither the intervention nor the placebo gum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel Function Recovery
Time Frame: 7 days
Time to first bowel movement or flatus
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Stay
Time Frame: 30 days
Length of postoperative hospital stay
30 days
Post-operative Vomiting
Time Frame: 30 days
Episodes of vomiting
30 days
Use of NG Tubes
Time Frame: 30 days
Nasogastric tube (re)insertions
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (ESTIMATE)

August 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRS-2012-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-operative Ileus

Clinical Trials on Nicotine gum

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe