Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics
- Conditions
- Cervical CancerUrinary Retention
- Interventions
- Procedure: BiClamp groupProcedure: water jet group
- Registration Number
- NCT03020238
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- FIGO stage IB
- ASA score 0-2
- Radiotherapy or chemotherapy before surgeries
- ASA score > 2
- With abnormal urinary dynamics before surgeries
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description BiClamp group BiClamp group BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus water jet group water jet group water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus
- Primary Outcome Measures
Name Time Method successful rate of removing urinary catheter 14th day after nerve-sparing radical hysterectomy successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml
- Secondary Outcome Measures
Name Time Method urinary dynamics parameters determined by urodynamics apparatus: bladder pressure four months after nerve-sparing radical hysterectomy bladder pressure in cmH2O
urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure four months after nerve-sparing radical hysterectomy detrusor pressure in cmH2O
urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation four months after nerve-sparing radical hysterectomy bladder capacity and sensation in ml
urinary dynamics parameters determined by urodynamics apparatus: urine flow rate four months after nerve-sparing radical hysterectomy urine flow rate in ml/s
urinary dynamics parameters determined by urodynamics apparatus: bladder compliance four months after nerve-sparing radical hysterectomy bladder compliance in ml/cmH2O
urinary dynamics parameters determined by urodynamics apparatus: residual urine volume four months after nerve-sparing radical hysterectomy residual urine volume in ml
survival outcomes: ovarall survival two years after nerve-sparing radical hysterectomy overall survival in months
survival outcomes: progression-free survival two years after nerve-sparing radical hysterectomy progression-free survival in months