NCT01130233Unknown3 期
Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Bladder function
研究概览
简要总结
Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery
This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.
详细描述
This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer
The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial.
The secondary outcome measures include
- The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups;
- The quality of life of the patients and the cost of the two groups
- The quality of the resected specimens
- The local recurrence rates at two years after the surgery
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 new case of rectal cancer with the lower border within 15 cm from anal verge
- •Age >18 years
- •Informed consent obtained
- •American Society of Anesthesiologist class 1-3
- •No contraindication to laparoscopic surgery
- •Acceptable operating risk
排除标准
- •Locally advanced fixed tumor with the need for exenterative surgery
- •Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
- •Multiple previous operations with the anticipation of dense peritoneal adhesions
- •No informed consent
结局指标
主要结局
Bladder function
时间窗: one year
Urodynamic Questionnaire
次要结局
- tumor status(One year)
- Quality of life(one year)
研究者
研究点 (1)
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