A multi-centre trial comparing laparoscopic surgery against robotic-assisted laparoscopic surgery for rectal cancer. International sites were required as only a limited number of UK sites were able to perform robotic assisted laparoscopic surgery at the time of set-up.
Countries: Australia, Denmark, Finland, France, Germany, Italy, Singapore, South Korea, the United Kingdom and the United States
The University of Leeds acted as sponsor for the trial, with co-ordination of the trial delegated to the Clinical Trials Research Unit at the University of Leeds.
The University of Leeds obtained funding for the trial as the host organisation. This included payments to facilitate delivery of the research at both UK and international sites, in addition to funding for a spoke units in the United States and Singapore
The University of Leeds contracted with each participating research site, and with the spoke unit in the United States. Initially, it had been planned that the US spoke unit would contract with participating sites in the United States, however this was not possible due to delays in getting the US spoke unit contract signed off.
The University of Leeds put in place insurance to legal liability for claims for injury arising from the Trial and where the University of Leeds was at fault e.g. due to an error in the protocol. International sites were responsible for ensuring appropriate insurance or indemnity for clinical negligence was in place in their respective country and in relation to their clinical activities related to the trial.
Participating international sites were contractually required to obtain required local approvals as per local regulations. Evidence of local approvals were collected prior to the site being opened to recruitment. International sites were responsible for local safety reporting as per local regulations.
One single protocol was used for both UK and international sites. Pragmatic trial design, operative specifics were at the discretion of the operating surgeon.
No trial specific monitoring was planned for the trial given the pragmatic nature of the trial however the sponsor reserved the right to conduct triggered site monitoring visits should any concerns have arisen as a result of central monitoring processes.
Distribution of Trial Supplies
Participating sites had to have the ability to perform both trial interventions in order to be eligible to take part in the trial therefore no surgical equipment was provided for trial purposes. Electronic Investigator Site Files (ISF) were sent to international sites.
International sites, not including sites in the United States, sent completed Case Report Forms (CRF) directly to the Clinical Trials Research Unit at the University of Leeds. This data was then entered onto the trial database by dedicated data entry staff. Sites in the United States sent their completed Case Report Forms (CRF) to the US spoke unit. The co-ordinator at the US spoke unit then entered the data from US sites onto the trial database which was accessed over the internet.
To enable a central pathological review, sites were required to send glass tissue slides or high quality digital slides scans to Leeds. If it was locally acceptable, patients were invited to donate additional tissue blocks for future research as an optional component of the trial. The trial budget covered shipping of tissue from sites to Leeds, and back to sites if they required the glass tissue slides to be returned.
Validated translations of patient completed quality of life questionnaires were used where available and combined into a booklet for each required time point, along with translated instructions for completion. The questionnaires used numerical scales and tick boxes (rather than free text fields) and the translated questionnaire booklets were laid out in an identical manner to the UK to facilitate data entry at the Clinical Trials Research Unit. The health economic analysis was performed with a UK NHS perspective, using data collected from UK and US patients.
Data Ownership & Publication
All trial data was owned by the University of Leeds as host institution. Sites were not permitted to publish concerning their patients which was directly relevant to the questions posed in the trial until the first publication of the primary endpoint analysis. All collaborators were listed as contributors, with top recruiting investigators named as authors (subject to journal requirements).