NCT02673177Unknown不适用
A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function
Southwest Hospital, China0 个研究点目标入组 225 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 主要终点
- Incidence of sexual and urinary dysfunction
研究概览
简要总结
This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.
详细描述
Urinary and sexual dysfunction are recognized complications of rectal cancer surgery in men. This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision(LTME) with regard to these functional outcomes.Sphincter- preservation outcomes for low rectal cancer was observed as well.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are acceptable to two surgical procedures for the robot- assisted or laparoscopy-assisted rectal cancer, are willing to randomized trial;
- •Matching the diagnostic criteria;
- •Aged 18-70 years old;
- •Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4);
- •Preoperative ASA 3 scores;
- •There was no history of malignancy, no other malignant tumors by preoperative examination;
- •Without undergoing definitive treatment, such as radiotherapy, chemotherapy or immunotherapy preoperatively;
- •The informed consent form was signed by the patient himself(herself)or his principal agent;
- •In accordance with the international erectile function questionnaire (IIEF) urinary function scale, The urinary sexual function are normal.
排除标准
- •Age less than 18 years old or more than 70 years old;
- •Previous psychiatric patients or patients refused to sign the informed consent;
- •Attending other related clinical studies on surgical treatment of rectal cancer;
- •The patient has a history of malignant tumor, or a combination of other malignant tumors;
- •Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy;
- •Patients had received otherper abdominal operations (except for laparoscopic cholecystectomy);
- •Laparoscopic surgical contraindications: such as severe heart lung disease; abdominal wall hernia; diaphragmatic hernia; coagulation disorder; portal hypertension; pregnancy, etc.;
- •Those who has been confirmed to be unable to do a radical resection (T4 stage) for local advanced tumor;
- •Those who have urination sexual dysfunction preoperatively.
结局指标
主要结局
Incidence of sexual and urinary dysfunction
时间窗: One years after surgery
次要结局
- disease-free survival(DFS )(3 years disease-free survival)
- Anus preservation rate(One years after surgery)
研究者
Tang Bo
Principal Investigator
Southwest Hospital, China
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