Randomized Clinical Trial of Conventional Versus Individual Extralevator Abdominoperineal Excision for Locally Advanced Lower Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The perioperative morbidity
研究概览
简要总结
An alternative treatment for low rectal cancer is the extralevator abdominoperineal excision (ELAPE) technique. We aim to compare the outcomes of patients undergoing conventional ELAPE versus Individual ELAPE.
详细描述
We suppose that the ELAPE technique may be performed according to individual conditions. For the rectal tumors suitable for ELAPE, most of them were circular or nearly circular infiltrating tumors. Patients with these rectal tumors should receive full ELAPE resection. In those rectal tumors not involving the levator ani muscle, the dissection plane may continue close to the external anal sphincter and the levator ani muscle, leaving the ischioanal fat and the terminal branches of the pudendal nerve intact.If the tumor has only penetrated into 1 side of the levator ani muscle, the dissection might include the levator ani muscle and the fat of the ischioanal fossa on the side of the tumor to achieve a clear circumferential resection margin, whereas the ischioanal fat and levator ani muscle on the other side of the tumor may be left
. This individual ELAPE may be as effective as conventional ELAPE while minimizing the operative trauma and the damage to the nerves of the genital organs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor within 5 cm of the anal verge or with a very narrow pelvis
- •T3-T4 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination or a low tumor is fixed or tethered at rectal examination
- •Absence of distant metastases
- •Absence of intestinal obstruction
排除标准
- •T1-T2 as determined by preoperative magnetic resonance imaging or endorectal ultrasonography examination
- •With distant metastases
- •With intestinal obstruction
- •Pregnancy or lactation
- •Allergic constitution to heterogeneous protein
- •With operation contraindication
研究组 & 干预措施
Individual ELAPE
Patients will receive Individual ELAPE technique
干预措施: Individual ELAPE (Procedure)
Conventional ELAPE
Patients with advanced lower rectal cancer will receive conventional EALPE technique
干预措施: conventional ELAPE (Procedure)
结局指标
主要结局
The perioperative morbidity
时间窗: three years
Sexual dysfunction,Urinary retention,Chronic perineal pain,Perineal wound infection,Urinary system infection,Pulmonary infection,Perineal seroma,Peristomal hernia,Abdominal wound infection,Perineal herniation
次要结局
- Three years survival postoperatively(three years)
研究者
Zhen Jun Wang
Professor
Beijing Chao Yang Hospital
