Condition category
Cancer
Date applied
27/04/2010
Date assigned
27/05/2010
Last edited
17/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr David Jayne

ORCID ID

Contact details

c/o CTRU
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44(0) 113 343 1477
rolarr@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01736072

Protocol/serial number

EME 08/52/01

Study information

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.

Acronym

ROLARR

Study hypothesis

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.

Link to EME project website: http://www.eme.ac.uk/projectfiles/085201info.pdf

Please note that as of 15/09/10 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.

As of 12/04/2011 the anticipated end date for this trial has been updated from 31/12/2011 to 31/07/2012.
As of 19/04/2011 Germany has been added to the countries of recruitment.
As of 17/09/2013 Brazil and Spain were removed and Australia, Denmark and Finland were added to the countries of recruitment, and the anticipated end date was changed from 31/07/2012 to 30/09/2014.

Ethics approval

Leeds West Research Ethics Committee, approved version 2.0 provisionally on 19/03/2010 (REC Number: 10/H1307/27)
Added 15/09/2010: Version 3.0 approved on the 24/08/2010
Added 19/04/2011: v4.0 01/03/2011 approved on 22/03/2011

Study design

International multicentre prospective randomised controlled unblinded parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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 surgeon’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

Current information as of 15/09/10:
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 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 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 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

Overall trial start date

01/06/2010

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 15/09/10:
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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Current information as of 15/09/10:
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

Recruitment start date

01/06/2010

Recruitment end date

30/09/2014

Locations

Countries of recruitment

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

Trial participating centre

c/o CTRU,
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

c/o Rachel de Souza
Faculty Research Ethics and Governance Administrator
Faculty of Medicine and Health Research Office
Room 10.110
Level 10
Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
+44 (0)113 343 2274
governance-ethics@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/52/01)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes