IntAct: Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery.
A non-CTIMP multicentre randomized controlled trial comparing surgery with IFA (intra-operative fluorescence angiography) against standard care (surgery with no IFA) to determine the effect on anastomotic leak in patients undergoing elective anterior resection for rectal cancer. Participating sites require certain equipment to be able to deliver the trial intervention; there were not enough UK sites with this equipment therefore international sites were required to be able to deliver the trial within reasonable timelines.
Countries: United Kingdom, Germany, Belgium, Switzerland, Ireland, Italy, Sweden, the Netherlands and France
The University of Leeds is acting 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 includes payments to facilitate delivery of the research at both UK and international sites.
The University of Leeds is contracting with all research sites.
The University of Leeds are putting in place insurance for legal liability for claims for injury arising from the Trial and where the University of Leeds is at fault e.g. due to an error in the protocol. International sites are 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 are contractually required to obtain required local approvals as per local regulations. Evidence of local approvals are collected prior to the site being opened to recruitment. International sites are responsible for local safety reporting as per local regulations.
Separate protocols were developed for the UK and for international sites to reflect different processes for international sites. The international version of the protocol was finalised once ethical approval was obtained in the UK. Pragmatic trial design, operative specifics and operative decision making are at the discretion of the operating surgeon.
No trial specific monitoring is planned for the trial given the pragmatic nature of the trial however the sponsor reserves the right to conduct triggered site monitoring visits should any concerns arise 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.
All sites send completed Case Report Forms (CRF) directly to the Clinical Trials Research Unit at the University of Leeds. This data is then entered onto the trial database by dedicated data entry staff.
Faecal samples at various timepoints are being collected from UK patients for a sub-study. The decision was made to not include international patients in this sub-study due to the logistics of collecting these in.
Validated translations of patient completed quality of life questionnaires are used where available and combined into a booklet for each required time point, along with translated instructions for completion. The questionnaires usenumerical scales and tick boxes (rather than free text fields) and the translated questionnaire booklets are laid out in an identical manner to the UK to facilitate data entry at the Clinical Trials Research Unit. The health economic analysis will be performed from a UK NHS perspective, using data collected from UK patients only.
Data Ownership & Publication
All trial data is owned by the University of Leeds as host institution. Sites are not permitted to publish concerning their patients which is directly relevant to the questions posed in the trial until the first publication of the primary endpoint analysis. All collaborators will be listed as contributors, with top recruiting investigators named as authors (subject to journal requirements).