Robotic versus laparoscopic resection for rectal cancer

Conditions

Rectal cancer, laparoscopic and robotic assisted laparoscopic surgery Cancer Malignant neoplasm of rectum

David Jayne, Alessio Pigazzi, Helen Marshall, Julie Croft, Neil Corrigan et al. (11 authors)

Efficacy and Mechanism Evaluation2019-09-0148 citations

Exploring and adjusting for potential learning effects in ROLARR: a randomised controlled trial comparing robotic-assisted vs. standard laparoscopic surgery for rectal cancer resection.

Corrigan N, Marshall H, Croft J, Copeland J, Jayne D, Brown J.

2018-06-2775 citations

10.1186/s13063-018-2726-0

Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer

David Jayne, Alessio Pigazzi, Helen Marshall, Julie Croft, Neil Corrigan et al. (16 authors)

JAMA2017-10-241,280 citations

10.1001/jama.2017.7219

Interventions

A total of 400 patients (200 in each arm) will be recruited into the trial over an 18-month period. It is anticipated that approximately 15 patients per month will be recruited in the first 6 months,

the only absolute requirement being that the robot is used for mesorectal resection. For the purposes of ROLARR, a totally robotic and a hybrid operation are defined as follows: 1. A t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Rate of conversion to open surgery as an indicator of surgical technical difficulty. Conversion is defined as the use of a laparotomy wound for any part of the mesorectal dissection. The use of a limited laparotomy wound to facilitate a low stapled anastomosis and/or specimen extraction is permissible and not defined as an open conversion.	—

Secondary

Measure	Time frame
Current information as of 15/09/2010: 1. Accuracy of surgery (oncological efficacy) 1.1. Pathological CRM positivity rates as recorded from local histopathology review, where resection margin positivity is defined as a distance of =1mm of the cancer from any resection margin. 1.2. 3-year local recurrence rates as calculated from the cumulative incidence function plot of time to local recurrence, where time to local recurrence is defined as the time from date of randomisation to date of local recurrence. Local recurrence is defined as evidence of locoregional disease within the surgical field. 2. Intra-operative and post-operative (30 day and 6 month) complications and 30-day operative mortality. Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 post-operative days 3. Patient self-reported bladder and sexual function as assessed by the International Prostate Symptom Score (IPSS) for male and female bladder function, and the International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI) for sexual function 4. Patient self-reported generic health related QoL as assessed by the SF-36 v2.0 and fatigue assessed by the Multidimensional Fatigue Inventory (MFI-20) 5. Three-year disease-free and overall survival. Overall survival is defined as the time from date of randomisation to date of death from any cause. Disease-free survival is defined according to Punt et al?s definitions as the time from date of randomisation to date of death from any cause, recurrent disease (locoregional or distant recurrence) or second primary cancer (the date of recurrence/secondary cancer is defined as the date of the relevant (e.g. clinical or radiological) assessment which detects the recurrence/secondary cancer). 6. Health economics: 6.1. Preference based QoL measured by EQ-5D an	—

Measure

Time frame

Current information as of 15/09/2010: 1. Accuracy of surgery (oncological efficacy) 1.1. Pathological CRM positivity rates as recorded from local histopathology review, where resection margin positivity is defined as a distance of =1mm of the cancer from any resection margin. 1.2. 3-year local recurrence rates as calculated from the cumulative incidence function plot of time to local recurrence, where time to local recurrence is defined as the time from date of randomisation to date of local recurrence. Local recurrence is defined as evidence of locoregional disease within the surgical field. 2. Intra-operative and post-operative (30 day and 6 month) complications and 30-day operative mortality. Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 post-operative days 3. Patient self-reported bladder and sexual function as assessed by the International Prostate Symptom Score (IPSS) for male and female bladder function, and the International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI) for sexual function 4. Patient self-reported generic health related QoL as assessed by the SF-36 v2.0 and fatigue assessed by the Multidimensional Fatigue Inventory (MFI-20) 5. Three-year disease-free and overall survival. Overall survival is defined as the time from date of randomisation to date of death from any cause. Disease-free survival is defined according to Punt et al?s definitions as the time from date of randomisation to date of death from any cause, recurrent disease (locoregional or distant recurrence) or second primary cancer (the date of recurrence/secondary cancer is defined as the date of the relevant (e.g. clinical or radiological) assessment which detects the recurrence/secondary cancer). 6. Health economics: 6.1. Preference based QoL measured by EQ-5D an

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Countries

Australia, Denmark, England, Finland, France, Germany, Italy, Korea, South, Singapore, United Kingdom, United States of America

Outcome results

None listed