Comparison of Limb Size of Transverse Coloplasty Pouch
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Kantonsspital Liestal.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kantonsspital Liestal
Information provided by:
Kantonsspital Liestal
ClinicalTrials.gov Identifier:
NCT01071824
First received: February 18, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 18, 2010 | ||||
| Last Updated Date | February 18, 2010 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pouch function 4 month after closure of protective ileostomy. [ Time Frame: 4 month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Pouch function 2 and 12 month respectively after closure of protective ileostomy. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| 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 | Comparison of Limb Size of Transverse Coloplasty Pouch | ||||
| Official Title ICMJE | Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision | ||||
| Brief Summary | The aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Rectal Resection | ||||
| 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 | 52 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01071824 | ||||
| Other Study ID Numbers ICMJE | 303/08 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Maurer Christoph A. / Prof. MD, KS Liestal | ||||
| Study Sponsor ICMJE | Kantonsspital Liestal | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Kantonsspital Liestal | ||||
| Verification Date | February 2010 | ||||
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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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