Locally advanced (LARC) and locally recurrent rectal cancer (LRRC) represent a specific cohort of patients with compromised radial tumour margins. Pelvic exenteration (PE) is an aggressive surgical approach that aims to remove all pelvic organs to ensure complete disease resection. Previous studies reporting on outcomes in colorectal cancer surgery have demonstrated a large heterogeneity in the field. A core outcome set (COS) that captures the consensus of clinicians and patients will help overcome heterogeneity in current outcome reporting in the literature facilitating meta-analysis of data and facilitating cross centre comparison of outcomes.
Currently, no COS for pelvic exenteration surgery exists. Some studies are currently in progress such as the CORRECT initiative which aims to develop a COS for clinical trials in rectal cancer. This initiative focuses on overall treatment however for rectal cancer in general. Pelvic exenterations are a very nuanced procedure with specific indications, significant variation in terms of reconstruction and extent of exenteration. There is also significant impact on patient quality of life. As such, current COS in development do not fully capture these nuances of this specific procedure especially as they focus on the plethora of non-operative strategies offered to rectal cancer patients currently. Our project aims to develop a COS for pelvic exenteration in LARC and LRRC specifically in association with the largest international pelvic exenteration consortium (PelvEx) to be utilised in both clinical trials and practice.
Dr Mahmoud M. Salama - St James Hospital, Dublin, Ireland
Mr Éanna J. Ryan - St James Hospital, Dublin, Ireland
Mr Michael E. Kelly - St James Hospital, Dublin, Ireland; Trinity St James Cancer Institute, Dublin Ireland
PelvEx Collaborative
Disease Category: Cancer
Disease Name: Rectal cancer
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Systematic review
We aim to carry out an international, multi-phasic, multi-centre, mixed-method study. Phase I encompasses a systematic review to identify the current reported outcomes in the literature. Phase II aims to identify outcomes of importance among key stakeholders. Phase III will achieve consensus on outcomes identified in the previous stage through a Delphi process. Phase IV will achieve final consensus on a COS. Phase V will integrate this COS in the current PelvEx database in an effort to standardise future reporting.