Clinical Function After Total Mesorectal Excision and Rectal Replacement. A Prospective Randomized Trial Comparing Side-to-End Anastomosis, Colon-J-Pouch and Straight Coloanal Anastomosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 18
- 主要终点
- Composite evacuation score after total mesorectal excision
研究概览
简要总结
RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery.
PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.
详细描述
This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (> 5 cm vs ≤ 5 cm), age (< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy
- •Total mesorectal excision needed
- •Age ≥ 18 years
- •Clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools)
- •Any T, any N, any M or adenoma
- •An R0-resection is expected (liver metastases planned to be simultaneously
- •Written informed consent, signed and dated by the patient and the investigator
- •Completed baseline quality of life questionnaire
排除标准
- •Rectal tumor other than adenocarcinoma or adenoma
- •Previous rectal cancer surgery, other than local excision within the last 2 months
- •Histologically proven chronic inflammatory bowel disease
- •Contraindications to any of the 3 surgical techniques
- •BMI > 35
- •Patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the QL questionnaires and/or following the structured interview
- •Inability to read and understand any of the languages available on the QL questionnaires,and spoken during the interview (German, French, Italian)
研究组 & 干预措施
Arm II
Patients undergo TME and colon-J-pouch anastomosis rectal reconstruction.
干预措施: 5 cm colon-J-pouch (Procedure)
Arm I
Patients undergo total mesorectal excision (TME) by standard methods or laparoscopically and side-to-end anastomosis rectal reconstruction.
干预措施: side-to-end anastomosis (Procedure)
Arm III
Patients undergo straight coloanal anastomosis with/without temporary protective ileostomy
干预措施: straight coloanal anastomosis (Procedure)
结局指标
主要结局
Composite evacuation score after total mesorectal excision
时间窗: 12 months after surgery
次要结局
- Quality of life after total mesorectal excision(6, 12m 18 and 24 months)
- Composite evacuation score at 6, 18, and 24 months after total mesorectal excision(6, 18 and 24 months after surgery)
- Composite incontinence score after total mesorectal excision(6, 12, 18 and 24 months)
- Morbidity(2 years follow-up)
- Overall survival(2 years follow-up)