Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- successful rate of removing urinary catheter
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO stage IB
- •ASA score 0-2
排除标准
- •Radiotherapy or chemotherapy before surgeries
- •ASA score > 2
- •With abnormal urinary dynamics before surgeries
结局指标
主要结局
successful rate of removing urinary catheter
时间窗: 14th day after nerve-sparing radical hysterectomy
successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml
次要结局
- urinary dynamics parameters determined by urodynamics apparatus: bladder pressure(four months after nerve-sparing radical hysterectomy)
- urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure(four months after nerve-sparing radical hysterectomy)
- urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation(four months after nerve-sparing radical hysterectomy)
- urinary dynamics parameters determined by urodynamics apparatus: urine flow rate(four months after nerve-sparing radical hysterectomy)
- urinary dynamics parameters determined by urodynamics apparatus: bladder compliance(four months after nerve-sparing radical hysterectomy)
- urinary dynamics parameters determined by urodynamics apparatus: residual urine volume(four months after nerve-sparing radical hysterectomy)
- survival outcomes: ovarall survival(two years after nerve-sparing radical hysterectomy)
- survival outcomes: progression-free survival(two years after nerve-sparing radical hysterectomy)
研究者
Lei Li
Associate Professor
Peking Union Medical College Hospital