Introduction: Anastomotic leak (AL) following rectal cancer resections are associated with significant morbidity, mortality, and compromised long-term oncologic outcomes. With an estimated rate of 15%, AL poses a significant challenge in colorectal surgery. Although there is a significant volume of research in this area, there is substantial heterogeneity in the reporting of AL outcomes. This makes the comparison between studies, data synthesis, and the ability to derive meaningful conclusions challenging. This project aims to develop a Core Outcome Set (COS) for AL in rectal cancer surgery, to be used as a guide in future research in this area which will ensure consistent and clinically appropriate reporting.
Methods: This study is designed as an international, multicentre, mixed-methods project. This will consist of four main components. This first phase being a systematic review of the literature to identify the current outcome reporting for AL in rectal cancer surgery. Phase II will identify the outcome priorities of stakeholders through qualitative interviews. Phase III will be a Delphi process to refine these core outcomes. Finally, phase IV will be a consensus to define which outcomes should be included in the final COS.
Dissemination: The finalised COS will be endorsed by relevant surgical societies. This will be integrated into clinical and academic practices to standardise future outcome reporting. This enables appropriate data synthesis and comparison to allow for application of the evidence base to clinical practice.
Prof Ronan A Cahill
Mr Eanna J Ryan
Dr Ruth Walsh
Disease Category: Cancer
Disease Name: Anastomotic Leak after Rectal Cancer Resection
Age Range: 18 - 90
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
This study is designed as an international, multicentre, mixed-methods project. This will consist of four main components. This first phase being a systematic review of the literature to identify the current outcome reporting for AL in rectal cancer surgery. Phase II will identify the outcome priorities of stakeholders through qualitative interviews. Phase III will be a Delphi process to refine these core outcomes. Finally, phase IV will be a consensus to define which outcomes should be included in the final COS.