BiClamp group
Procedureelectric energy
Other names: BiClamp® forcep, ERBE Elektromedizin
NCT Number: NCT03020238
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.
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Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
electric energy
Other names: BiClamp® forcep, ERBE Elektromedizin
water jet energy
Other names: ERBEJET®2, ERBE Elektromedizin
Time frame: 14th day after nerve-sparing radical hysterectomy
successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml
Time frame: four months after nerve-sparing radical hysterectomy
bladder capacity and sensation in ml
Time frame: four months after nerve-sparing radical hysterectomy
residual urine volume in ml
Time frame: four months after nerve-sparing radical hysterectomy
urine flow rate in ml/s
Time frame: four months after nerve-sparing radical hysterectomy
bladder pressure in cmH2O
Time frame: four months after nerve-sparing radical hysterectomy
detrusor pressure in cmH2O
Time frame: four months after nerve-sparing radical hysterectomy
bladder compliance in ml/cmH2O
Time frame: two years after nerve-sparing radical hysterectomy
overall survival in months
Time frame: two years after nerve-sparing radical hysterectomy
progression-free survival in months
Peking Union Medical College Hospital
Other
Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial
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