Estudio A.P.PRO: Estrategia quirúrgica en la amputación Abdominoperineal cilíndrica Del Recto Por cáncer: posición de litotomía vs. Prono-navaja
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 280
- 试验地点
- 19
- 主要终点
- Assessment of the circumferential resection margin
研究概览
简要总结
Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer.
Primary objective:
- Pathological circumferential resection margin
Secondary objectives:
- 5 year oncological outcomes
- Morbimortality rates
- Surgical specimen quality
- Perineal hernia incidence
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in MRI
排除标准
- •American Society of Anaesthesiologists classification of Physical Health (ASA) IV patients
- •Locally palliative purpose of the operation
- •Age < 18 years
- •Preoperative indication for pelvic exenteration
- •Pregnancy
- •Lack of patients consent
研究组 & 干预措施
Supine position
Abdominoperineal resection - perineal time- in supine position
干预措施: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer (Procedure)
Prone position
Abdominoperineal resection - perineal time- in prone position
干预措施: Abdominoperineal extra-elevators rectal resection for low lying rectal cancer (Procedure)
结局指标
主要结局
Assessment of the circumferential resection margin
时间窗: 15-30 days after surgery date
Histopathological report of the circumferential resection margin of the surgical specimen obtained in patients that underwent perineal time of Miles procedure in prone vs supine position.
次要结局
- Histopathological quality of surgical specimen(15-30 days after)
研究者
Matteo Frasson
MD, PhD
Hospital Universitario La Fe