A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy
This study is currently recruiting participants.
Verified April 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00895284
First received: May 6, 2009
Last updated: April 18, 2013
Last verified: April 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 6, 2009 | ||||
| Last Updated Date | April 18, 2013 | ||||
| Start Date ICMJE | March 2007 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
total procedure time - skin incision to skin closure [ Time Frame: At skin closure. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00895284 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy | ||||
| Official Title ICMJE | Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial | ||||
| Brief Summary | This study is aimed to compare the standard laparoscopic approach to the hysterectomy with the robotic approach. The time it takes to perform the procedure, blood loss, complications during the surgery and 6 weeks after surgery will be evaluated. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hysterectomy | ||||
| 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 | 100 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited. Exclusion Criteria: - Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis. |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00895284 | ||||
| Other Study ID Numbers ICMJE | 06-008892 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rosanne Kho MD, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | April 2013 | ||||
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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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