Back to resultsNicotine Gum Recovery After Colorectal Surgery
Primary Purpose
Post-operative Ileus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nicotine gum
Regular chewing gum
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Ileus focused on measuring ILEUS
Eligibility 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
Sites / Locations
- Cleveland Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
No Intervention
Arm Label
Nicotine gum
regular chewing gum
No gum
Arm Description
100 subjects who will actually get the intervention medication
100 subjects who will be part of a control group
100 subjects who will not get neither the intervention nor the placebo gum.
Outcomes
Primary Outcome Measures
Bowel Function Recovery
Time to first bowel movement or flatus
Secondary Outcome Measures
Hospital Stay
Length of postoperative hospital stay
Post-operative Vomiting
Episodes of vomiting
Use of NG Tubes
Nasogastric tube (re)insertions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01662115
Brief Title
Nicotine Gum Recovery After Colorectal Surgery
Official Title
Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Study has been terminated due linability to recruit the targeted participants. Aimed for 300 participants and only 4 were enrolled after 1 year.
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Ileus
Keywords
ILEUS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine gum
Arm Type
Active Comparator
Arm Description
100 subjects who will actually get the intervention medication
Arm Title
regular chewing gum
Arm Type
Sham Comparator
Arm Description
100 subjects who will be part of a control group
Arm Title
No gum
Arm Type
No Intervention
Arm Description
100 subjects who will not get neither the intervention nor the placebo gum.
Intervention Type
Drug
Intervention Name(s)
Nicotine gum
Other Intervention Name(s)
Nicorrete gum
Intervention Description
Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
Intervention Type
Other
Intervention Name(s)
Regular chewing gum
Other Intervention Name(s)
Sugarlees chewing gum
Intervention Description
Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
Primary Outcome Measure Information:
Title
Bowel Function Recovery
Description
Time to first bowel movement or flatus
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Hospital Stay
Description
Length of postoperative hospital stay
Time Frame
30 days
Title
Post-operative Vomiting
Description
Episodes of vomiting
Time Frame
30 days
Title
Use of NG Tubes
Description
Nasogastric tube (re)insertions
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ERIC G WEISS, MD
Organizational Affiliation
Cleveland Clinic Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nicotine Gum Recovery After Colorectal Surgery
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