Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of complications
研究概览
简要总结
The purpose of the study is to evaluate the incidence of surgery-related complications between Day 0 and Day 30.
详细描述
This is an observational, prospective, open, non-comparative (single arm), bicentric study.
This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. The possibility of performing this procedure on an outpatient basis is left to the surgeon's discretion, according to well-defined medical procedure criteria.
This cohort is part of the usual care. The study will observe the incidence and describe the type, number, severity, duration and frequency of procedure-related complications that may arise in the first month post-op of ambulatory Laparoscopic Radical Prostatectomy. For this reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, age ≥ 18 years;
- •Localized prostate cancer;
- •Validation in a multidisciplinary consultation meeting of curative treatment;
- •Scheduled laparoscopic radical prostatectomy;
- •Patient able to understand the information related to the study, to read the information leaflet and to signify his/her non-opposition or opposition to participating in the study;
- •Membership of a social security scheme;
- •Patient having been informed and having given oral non-opposition.
排除标准
- •Surgical emergency;
- •Patient not eligible for ambulatory care;
- •Long-term curative anti-coagulant treatment;
- •Resident more than 100km from the clinic;
- •Home alone the first night;
- •Patient under guardianship, curatorship or deprivation of liberty.
结局指标
主要结局
Incidence of complications
时间窗: 30 days
The primary endpoint was the incidence of procedural complications between Day 0 and Day 30.
次要结局
未报告次要终点