Randomized Trial on Robotic Assisted Resection for Rectal Cancer
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| First Received Date ICMJE | May 24, 2010 | ||||
| Last Updated Date | May 24, 2010 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Bladder function [ Time Frame: one year ] [ Designated as safety issue: No ] Urodynamic Questionnaire |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| 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 | Randomized Trial on Robotic Assisted Resection for Rectal Cancer | ||||
| Official Title ICMJE | Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer | ||||
| Brief Summary | Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer. |
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| Detailed Description | This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial. The secondary outcome measures include
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| 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 | 98 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | June 2014 (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 | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01130233 | ||||
| Other Study ID Numbers ICMJE | UW 09-132 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Professor Wai Lun LAW, The University of Hong Kong | ||||
| Study Sponsor ICMJE | The University of Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Hong Kong | ||||
| Verification Date | May 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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