Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics
NCT ID: NCT03020238
Last Updated: 2017-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2013-01-31
2017-01-31
Brief Summary
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Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.
Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to randomly allocated to BiClamp group or water jet group.
Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.
Methods: All surgical patients are accessed via urinary dynamics before and four months after NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine volume (RUV) will be measured. For patients of RUV \> 100 ml, urinary catheter will be replaced.
Primary study endpoint: the successful rate of removing urinary catheter on the 14th day after NSRH.
Secondary study endpoint: urinary dynamics four months after NSRH.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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BiClamp group
BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus
BiClamp group
electric energy
water jet group
water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus
water jet group
water jet energy
Interventions
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BiClamp group
electric energy
water jet group
water jet energy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA score 0-2
Exclusion Criteria
* ASA score \> 2
* With abnormal urinary dynamics before surgeries
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Lei Li
Associate Professor
Principal Investigators
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Wu Ming, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Other Identifiers
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PUMCH-OBGYN-2013
Identifier Type: -
Identifier Source: org_study_id
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