NCT01662115

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

August 22, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

August 7, 2012

Results QC Date

April 13, 2017

Last Update Submit

August 21, 2017

Conditions

Post-operative Ileus

Keywords

ILEUS

Outcome Measures

Primary Outcomes (1)

  • Bowel Function Recovery

    Time to first bowel movement or flatus

    7 days

Secondary Outcomes (3)

  • Hospital Stay

    30 days

  • Post-operative Vomiting

    30 days

  • Use of NG Tubes

    30 days

Study Arms (3)

Nicotine gum

ACTIVE COMPARATOR

100 subjects who will actually get the intervention medication

Drug: Nicotine gum

regular chewing gum

SHAM COMPARATOR

100 subjects who will be part of a control group

Other: Regular chewing gum

No gum

NO INTERVENTION

100 subjects who will not get neither the intervention nor the placebo gum.

Interventions

Nicotine gumDRUG

Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first

Also known as: Nicorrete gum
Nicotine gum
Regular chewing gumOTHER

Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first

Also known as: Sugarlees chewing gum
regular chewing gum

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Ileus

Interventions

Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Chewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Limitations and Caveats

Principal Investigator decided for an early termination of the enrollment period due to small numbers of subjects consented, with limited data to make conclusions.

Results Point of Contact

Title
Chief Academic Office
Organization
Cleveland Clinic Florida
weisse@ccf.org
9546595278

Study Officials

  • ERIC G WEISS, MD

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DIO and Chairman of Graduate Medical Education at Cleveland Clinic Florida,

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 10, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 22, 2017

Results First Posted

August 22, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)