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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
Results First Submitted: April 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Post-operative Ileus
Interventions: Drug: Nicotine gum
Other: Regular chewing gum

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nicotine Gum

100 subjects who will actually get the intervention medication

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

Regular Chewing Gum

100 subjects who will be part of a control group

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

No Gum 100 subjects who will not get neither the intervention nor the placebo gum.

Participant Flow:   Overall Study
    Nicotine Gum   Regular Chewing Gum   No Gum
STARTED   2   2   0 
COMPLETED   2   2   0 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nicotine Gum

100 subjects who will actually get the intervention medication

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

Regular Chewing Gum

100 subjects who will be part of a control group

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

No Gum 100 subjects who will not get neither the intervention nor the placebo gum.
Total Total of all reporting groups

Baseline Measures
   Nicotine Gum   Regular Chewing Gum   No Gum   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   0   4 
Age 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 2   2   0   4 
<=18 years      0   0.0%      0   0.0%         0   0.0% 
Between 18 and 65 years      1  50.0%      1  50.0%         2  50.0% 
>=65 years      1  50.0%      1  50.0%         2  50.0% 
Age 
[Units: Years]
Mean (Full Range)
       
Participants Analyzed 
[Units: Participants]
 2   2   0   4 
   58 
 (48 to 69) 
 66 
 (57 to 76) 
    62 
 (48 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 2   2   0   4 
Female      1  50.0%      0   0.0%         1  25.0% 
Male      1  50.0%      2 100.0%         3  75.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 0   0   0   0 
            0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
       
United States         
Participants Analyzed 
[Units: Participants]
 2   2   0   4 
United States   2   2      4 


  Outcome Measures
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1.  Primary:   Bowel Function Recovery   [ Time Frame: 7 days ]

2.  Secondary:   Hospital Stay   [ Time Frame: 30 days ]

3.  Secondary:   Post-operative Vomiting   [ Time Frame: 30 days ]

4.  Secondary:   Use of NG Tubes   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Principal Investigator decided for an early termination of the enrollment period due to small numbers of subjects consented, with limited data to make conclusions.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chief Academic Office
Organization: Cleveland Clinic Florida
phone: 9546595278
e-mail: weisse@ccf.org



Responsible Party: Eric Weiss, 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