Laparoscopic Versus Robotic-Assisted Surgery for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Rate of conversion to open surgery as an indicator of surgical technical difficulty
研究概览
简要总结
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether robotic-assisted laparoscopic surgery is more effective than laparoscopic surgery in treating patients with rectal cancer.
PURPOSE: This randomized clinical trial studies robotic-assisted laparoscopic surgery to see how well it works compared to laparoscopic surgery in treating patients with rectal cancer that can be removed by surgery.
详细描述
OBJECTIVES:
I. To evaluate robotic-assisted rectal cancer surgery versus standard laparoscopic rectal cancer resection by means of a randomized, controlled trial.
II. To assess technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation.
III. To assess surgical accuracy and improved oncological outcome as determined by clear pathological resection margins.
IV. To assess quality of life and analyze cost-effectiveness to aid evidence-based knowledge to inform NHS and other service providers and decision-makers.
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
- •Able to provide written informed consent
- •Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by CT and MRI or transrectal ultrasound)
- •Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
- •Fit for robotic-assisted or standard laparoscopic rectal resection
- •ASA =< 3
- •Capable of completing required questionnaires at time of consent
- •Benign lesions of the rectum
- •Cancers of the anal canal
- •Locally advanced cancers not amenable to curative surgery
- •Locally advanced cancers requiring en bloc multi-visceral resection
- •Synchronous colorectal tumours requiring multi-segment surgical resection
- •Co-existent inflammatory bowel disease
- •Clinical or radiological evidence of metastatic spread
- •Concurrent or previous diagnosis of invasive cancer within 5 years that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer treated with curative intent are acceptable; for other cases please discuss with Chief Investigator via CTRU)
- •History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
- •Pregnancy
- •Participation in another rectal cancer clinical trial relating to surgical technique
排除标准
- 未提供
结局指标
主要结局
Rate of conversion to open surgery as an indicator of surgical technical difficulty
时间窗: At completion of surgery
次要结局
- Intra-operative laparoscopic skills (randomly selected cases only) as assessed by the global assessment tool for evaluation of intra-operative laparoscopic skills (GOALS)(Upon completion of GOALS assessment by an independent expert)
- Health economics(At day 30 and 6 months)
- Circumferential resection margin positivity rate(At completion of pathology review)
- Local recurrence rate(At 3 years)
- Self reported bladder and sexual function(At day 30 and 6 months)
- Health related quality of life(At day 30 and 6 months)
- Intra-operative and post-operative complications(At day 30 and 6 months)
- Operative mortality(At day 30)
- Disease free and overall survival(At 3 years)
- Quality of the plane of surgery as assessed by central review of photographs(At completion of the central review of photographs)