Prospective Multicenter Randomized Controlled Trial Comparing Postoperative Complications and Quality of Life in Low Rectal Cancer Surgery Between Coloanal Anastomosis and Lateral Ileostomy Versus Two-Stage Turnbull-Cutait Coloanal Anastomosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 7
- 主要终点
- post-operative morbidity
研究概览
简要总结
The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure in comparison to the standard surgery for low rectal cancer. The investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.
详细描述
Anastomotic leak represents the most frequent complication after rectal cancer surgery and a lateral covering ileostomy is usually performed to reduce its incidence. Other important consequences of rectal cancer surgery are alterations in bowel habits and function and a negative impact on quality of life. This prospective, randomized, multicenter and controlled trial compares post-operative complications, quality of life, faecal incontinence and recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis protected by a lateral ileostomy or with a two-staged Turnbull-Cutait colo-anal anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy established by rigid proctoscopy, with histological confirmation and candidates of colo-anal anastomosis;
- •Patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical treatment;
- •Patients who undergo an ultra-low anterior rectal resection with total mesorectal excision and nerve and sphincter-sparing with curative intention
- •Any extension of the primary tumor (T 1-2-3-4) according to the TNM classification;
- •Patients with or without lymph node metastasis (N - / +) and with or without resectable distant metastases;
- •Patients clinically without fecal incontinence prior to the current illness and with a Wexner incontinence Score less than or equal to 5;
- •Patients ASA I, II or III and adequate hematological, renal and hepatic function;
- •Patients who signed informed consent.
排除标准
- •Altered cognitive state(eg mental retardation or dementia) that prevents collaboration in the study or patients who can neither read nor write
- •Fecal incontinence (Wexner equal to or greater than 6);
- •Previous surgery or proctological, colonic and anorectal functional disease
- •Diagnosis of synchronous colorectal or any other active neoplasm;
- •Patients ASA IV, V;
- •Pregnancy and lactation;
- •Rejection of the patient to sign the consent form.
研究组 & 干预措施
Coloanal anastomosis with ileostomy
Hand-sewn coloanal anastomosis protected by a loop ileostomy
干预措施: Hand-sewn coloanal anastomosis (Procedure)
Coloanal anastomosis with ileostomy
Hand-sewn coloanal anastomosis protected by a loop ileostomy
干预措施: Ultralow anterior rectal resection with total mesorectal excision (Procedure)
Two stage Turnbull-Cutait anastomosis
Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).
干预措施: Two staged Turnbull-Cutait procedure (Procedure)
Two stage Turnbull-Cutait anastomosis
Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).
干预措施: Ultralow anterior rectal resection with total mesorectal excision (Procedure)
结局指标
主要结局
post-operative morbidity
时间窗: within the first 30 days after surgery
次要结局
- local and/or distant recurrence of neoplasm(3 years)
- Quality of life(3 years)
- Fecal incontinence(3 years)
研究者
Sebastiano Biondo
PhD, MD
Hospital Universitari de Bellvitge