A Multicentre Trial of Nerve-Spring Radical Hysterectomy vs. Radical Hysterectomy for Cervical Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- maximum flow rate measured by Urodynamic at 6 months postoperative
研究概览
简要总结
The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy
- •Possible to radical hysterectomy or nerve-spring radical hysterectomy
- •Age: 17 to 60 years
- •No complication during operation
- •Written informed consent
排除标准
- •patients who underwent radiotherapy
- •Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma
- •Patients who have uncontrolled diabetes or uncontrolled hypertension
- •patients with neurogenic bladder dysfunction
- •patients with uterine prolapse
- •Patients with psychiatric illness
- •Patients who have active infection
- •Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
- •Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
研究组 & 干预措施
RH
patients in Arm RH undergo radical hysterectomy (RH)
干预措施: radical hysterectomy (Procedure)
NSRH
patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH)
干预措施: Nerve-spring radical hysterectomy (Procedure)
结局指标
主要结局
maximum flow rate measured by Urodynamic at 6 months postoperative
时间窗: on 6 months postoperative
residual volume measured by Urodynamic at 6 months postoperative
时间窗: on 6 months postoperative
maximum vesical compliace measured by Urodynamic at 6 months postoperative
时间窗: on 6 months postoperative
cystometric capacity at first desire measured by Urodynamic at 6 months postoperative
时间窗: on 6 months postoperative
maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative
时间窗: on 6 months postoperative
次要结局
- Time (days) to residual urine volume less than 100ml postoperative(from operation to residual urine volume less than 100ml, assessed up to 30 days)
- time (hours) to break wind postoperative(from operation to have the first break wind, assessed up to 72 hours)
- time (hours) to defecation postoperative(from operation to have the first defection, assessed up to 72 hours)
- Number of participants with adverse events(From date of operation until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 5 years)
- Score of MHU rating scales at 6 months postoperative(on 6 months postoperative)
- overall survival(From date of operation until the date of death from any cause, assessed up to 5 years)
- progression-free survival(From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years)
- Score of C-30 life quality rating scales at 6 months postoperative(on 6 months postoperative)
- Score of CX-24 life quality rating scales at 6 months postoperative(on 6 months postoperative)