Cervical Cancer, Urinary Retention
Conditions
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.
Interventions
electric energy
water jet energy
Sponsors
Study design
Eligibility
Inclusion criteria
* FIGO stage IB * ASA score 0-2
Exclusion criteria
* Radiotherapy or chemotherapy before surgeries * ASA score \> 2 * With abnormal urinary dynamics before surgeries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| urinary dynamics parameters determined by urodynamics apparatus: residual urine volume | four months after nerve-sparing radical hysterectomy | residual urine volume 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 pressure | four months after nerve-sparing radical hysterectomy | bladder 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: bladder compliance | four months after nerve-sparing radical hysterectomy | bladder compliance in ml/cmH2O |
| 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 |
| urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure | four months after nerve-sparing radical hysterectomy | detrusor pressure in cmH2O |