Nicotine Gum Recovery After Colorectal Surgery
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| First Received Date ICMJE | August 7, 2012 | ||||||||
| Last Updated Date | August 9, 2012 | ||||||||
| Start Date ICMJE | August 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Bowel function recovery [ Time Frame: 7 days ] [ Designated as safety issue: No ] Time to first bowel movement or flatus |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01662115 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Nicotine Gum Recovery After Colorectal Surgery | ||||||||
| Official Title ICMJE | Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery? | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Post-operative Ileus | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | March 2013 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01662115 | ||||||||
| Other Study ID Numbers ICMJE | CRS-2012-05 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Eric Weiss, Cleveland Clinic Florida | ||||||||
| Study Sponsor ICMJE | Cleveland Clinic Florida | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Cleveland Clinic Florida | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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