ISRCTN80500123已完成未知
RObotic versus LAparoscopic Resection for Rectal cancer: an international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic assisted versus laparoscopic surgery for the curative treatment of rectal cancer
niversity of Leeds (UK)0 个研究点目标入组 466 人开始时间: 2010年5月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 466
研究概览
简要总结
2012 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/21912876 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29945673 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32097165 sub study results (added 26/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current information as of 15/09/2010:
- •1. Aged greater than or equal to 18 years
- •2. Able to provide written informed consent
- •3. Diagnosis of rectal cancer* amenable to curative surgery either by low anterior resection, high anterior resection, or abdominoperineal resection i.e. staged T1-3, N0-2, M0 by imaging as per local practice; although not mandated, CT imaging with either additional MRI or transrectal ultrasound is recommended to assess distant and local disease.
- •(*For the purposes of the ROLARR trial, rectal cancer is defined as an adenocarcinoma whose distal extent is situated at or within 15cm of the anal margin as assessed by endoscopic examination or radiological contrast study)
- •4. Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
- •5. Fit for robotic-assisted or standard laparoscopic rectal resection
- •6. American Society of Anestheologists (ASA) physical status classification less than or equal to 3
- •7. Capable of completing required questionnaires at time of consent
- •Initial information at time of registration:
- •1. Aged greater than or equal to 18 years
- •2. Able to provide written informed consent
- •3. Diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection (i.e. staged T1-3, N0-2, M0 by Computed Tomography [CT] and Magnetic Resonance Imaging [MRI] or transrectal ultrasound)
- •4. Rectal cancer suitable for resection by either standard or robotic-assisted laparoscopic procedure
- •5. Fit for robotic-assisted or standard laparoscopic rectal resection
- •6. American Society of Anestheologists (ASA) physical status classification less than or equal to P3
- •7. Capable of completing required questionnaires at time of consent
排除标准
- •Current information as of 15/09/2010:
- •1. Benign lesions of the rectum
- •2. Benign or malignant diseases of the anal canal
- •3. Locally advanced cancers not amenable to curative surgery
- •4. Locally advanced cancers requiring en bloc multi-visceral resection
- •5. Synchronous colorectal tumours requiring multi-segment surgical resection (n.b. a benign lesion within the resection field in addition to the main cancer would not exclude a patient)
- •6. Co-existent inflammatory bowel disease
- •7. Clinical or radiological evidence of metastatic spread
- •8. 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 Clinical Trials Research Unit [CTRU])
- •9. 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
- •10. Pregnancy (a pregnancy test is not mandated for the purpose of this trial)
- •11. Participation in another rectal cancer clinical trial relating to surgical technique
- •Initial information at time of registration
- •1. Benign lesions of the rectum
- •2. Cancers of the anal canal
- •3. Locally advanced cancers not amenable to curative surgery
- •4. Locally advanced cancers requiring en bloc multi-visceral resection
- •5. Synchronous colorectal tumours requiring multi-segment surgical resection
- •6. Co-existent inflammatory bowel disease
- •7. Clinical or radiological evidence of metastatic spread
- •8. 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 Clinical Trials Research Unit [CTRU])
- •9. 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
- •10. Pregnancy
- •11. Participation in another rectal cancer clinical trial relating to surgical technique
研究者
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