Cervical Cancer Clinical Trial
Official title:
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial
Background: Radical hysterectomy is an important therapy for early cervical cancer.
Disfunction of urinary dynamics is the most common postoperative adverse effects, which had
negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH)
could reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving
postoperative urinary dynamics. Furthermore impact of different energy instruments on
urinary dynamic isn't clear.
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.
n/a
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