Robotic versus laparoscopic resection for rectal cancer

ISRCTN	ISRCTN80500123
DOI	https://doi.org/10.1186/ISRCTN80500123
ClinicalTrials.gov (NCT)	NCT01736072
Protocol serial number	EME 08/52/01
Sponsor	University of Leeds (UK)
Funders	Medical Research Council, Efficacy and Mechanism Evaluation Programme (ref: EME 08/52/01)

Submission date: 27/04/2010
Registration date: 27/05/2010
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-robotic-assisted-keyhole-surgery-for-cancer-of-the-rectum

Contact information

Mr David Jayne
Scientific

CTRU
University of Leeds
Leeds
LS2 9JT
United Kingdom

Phone	+44 (0)113 343 1477
Email	rolarr@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	International multicentre prospective randomised controlled unblinded parallel-group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	ROLARR
Study objectives	The current proposal aims to test the hypothesis that robotic-assistance facilitates laparoscopic rectal cancer surgery. On short-term follow-up this should result in a reduction in the conversion rate and no worsening of the circumferential resection margin (CRM) positivity rate. On longer-term follow-up, the increased accuracy should improve post-operative bladder and sexual function, enhance quality of life (QoL), and ensure there is no increase in local disease recurrence. More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/eme/085201/#/
Ethics approval(s)	Leeds West Research Ethics Committee, version 2.0 approved provisionally on 19/03/2010, ref: 10/H1307/27 Version 3.0 approved 24/08/2010 v4.0 01/03/2011 approved 22/03/2011
Health condition(s) or problem(s) studied	Rectal cancer, laparoscopic and robotic assisted laparoscopic surgery
Intervention	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, with monthly recruitment increasing to approximately 25 patients in the final 12 months. Patients will be randomised on a 1:1 basis to receive either robotic-assisted or standard laparoscopic rectal cancer surgery and will be allocated a unique trial number. Laparoscopic mesorectal resection will be performed in accordance with each surgeons usual practice. Robotic-assisted laparoscopic surgery may involve either a totally robotic or a hybrid approach; 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 totally robotic operation involves a resection of the entire surgical specimen with the use of robotic-assistance. 2. A hybrid operation involves the use of laparoscopic techniques to mobilise the proximal colon with robotic-assistance employed to perform the rectal mesorectal dissection.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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 als 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 and used to calculate quality-adjusted life-years (QALYs) 6.2. Direct resource utilisation 6.3. Cost-effectiveness estimated using QoL and direct resource use information combined with apportioned cost scenarios of the robotic device 6.4. Intra-operative laparoscopic skills (randomly selected cases only) as assessed by an independent expert blind to surgeon and surgery performed using the global assessment tool for evaluation of intra-operative laparoscopic skills 'GOALS' 6.5. Quality of the plane of surgery as assessed by local histopathology review as detailed in Appendix 1 of the protocol Initial information at time of registration: 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 als 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 5. 6. Health economics: 6.1. Preference based QoL measured by EQ-5D and used to calculate quality-adjusted life-years (QALYs) 6.2. Direct resource utilisation 6.3. Cost-effectiveness estimated using QoL and direct resource use information combined with apportioned cost scenarios of the robotic device 6.4. Intra-operative laparoscopic skills (randomly selected cases only) as assessed by an independent expert blind to surgeon and surgery performed using the global assessment tool for evaluation of intra-operative laparoscopic skills 'GOALS' 6.5. Quality of the plane of surgery as assessed by central review of photographs, blind to surgeon and surgery performed
Completion date	30/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	400
Total final enrolment	466
Key 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
Key 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
Date of first enrolment	01/06/2010
Date of final enrolment	30/09/2014

Locations

Countries of recruitment

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

Study participating centre

University of Leeds

Leeds
LS2 9JT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/06/2018		Yes	No
Results article	sub study results	01/02/2020	26/02/2020	Yes	No
Protocol article	protocol	01/02/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
26/02/2020: Publication reference added.
28/06/2018: Publication reference added.
24/01/2017: Publication reference added.
17/09/2013: Brazil and Spain were removed and Australia, Denmark and Finland were added to the countries of recruitment, and the overall trial end date was changed from 31/07/2012 to 30/09/2014.
19/04/2011: Germany has been added to the countries of recruitment.
12/04/2011: The overall trial end date was changed from 31/12/2011 to 31/07/2012.
15/09/2010: This record has been updated. Details of these updates can be found in the relevant field with the above update date. Version 3.0 of the trial protocol is currently in effect. The initial information at the time of registration (v. 2.0) was not used in the recruitment process. Brazil, France, South Korea and Spain have been added to the countries of recruitment. Canada and Hong Kong have been removed from countries of recruitment.