Exploratory Study for Evaluating the Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION Trial V)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluating efficacy of PAMS I by comparison with IOM
研究概览
简要总结
Although nerve-sparing surgery has been introduced for female patients with the pelvic tumors, its success rate depends on operators. To achieve consistency of surgical procedure, It is necessary to adopt pelvic autonomic nerve monitoring technique.
The Aims of this study is
- Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system.
- Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I
- Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)
详细描述
After surgery for pelvic tumor, most of patients complain voiding dysfunction, defecation dysfunction and sexual dysfunction which lead to decrease quality of life. Recently, nerve-sparing surgery has been introduced. But it is difficult to establish standard surgical procedure for nerve-sparing. And it is the concern that performing nerve sparing surgery may reduce radicality of surgery which influence prognosis.
Through pelvic autonomic nerve monitoring system (PAMS I), this trial is expected to raise the possibility of nerve-sparing with maintaining radicality of surgery.
Pressure sensor of PAMS I and needle prove of IOM are very thin and these instruments have been used clinically. Taking this into consideration, additional risk by nerve monitoring is considered to be minimal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, Age ≥ 18 years
- •Patients with pelvic malignant tumor who need surgery.
- •Gynecologic cancer; cervical cancer, uterine cancer, ovarian cancer
- •Colorectal cancer
- •Pelvic sarcoma and metastatic pelvic malignant tumor
- •Patients who signed an approved informed consent.
排除标准
- •Female, Age < 18 years
- •Patients with pelvic malignant tumor, but surgery is not indicated.
- •Patients who refused to sign informed consent
结局指标
主要结局
Evaluating efficacy of PAMS I by comparison with IOM
时间窗: Intraoperative
Comparision pressure change on PAMS I with nerve conduction on IOM i) PAMS I (+) \& IOM (+): nerve-sparing ii) PAMS I (-) \& IOM (-): nerve damage iii) PAMS I (+) \& IOM (-) or PAMS I (-) \& IOM (+): intermediate
次要结局
- Anorectal manometry(Preoperative, 3 months after surgery)
- Urodynamic test(Preoperative, 3 months after surgery)
- Evaluation of Quality of life.(Preoperative, 3 months after surgery)
- Time period for recovering normal voiding function(postoperative (up to 6 month))
研究者
Hee Seung Kim
Associate Professor
Seoul National University Hospital