Core Outcome Set for Cytoreductive Surgery for Colorectal Cancer with Peritoneal Metastases

Recently the number of clinical studies surrounding cytoreductive surgery (CRS) for colorectal cancer with peritoneal metastases (CRPM) has increased significantly. As the number of centres offering cytoreductive surgery increases worldwide, research is focused on establishing better patient selection, and ensuring new techniques have positive impacts on survival. However there have been few randomised controlled trials reporting comprehensive quality of life outcomes, side effects and feasibility, suggesting key stakeholders, including patients, may be underrepresented. This project aims to generate international agreement on a core outcome set (COS) for cytoreductive surgery with or without intraperitoneal chemotherapy for the treatment of CRPM, validated by clinicians and patients.

Whilst core outcome sets have been validated and published for colorectal cancer broadly, this unique group of patients have a poor baseline mortality, and CRS interventions carry a great risk of morbidity and complications compared to other interventions for colorectal cancer. Hence this projects aims to build from these core outcomes, and help to support consistency in outcomes reported in future CRS research and promote homogenous comparison across trials, optimising the utility of research findings, for a high value surgery, targeted to a vulnerable population.

Contributors

PRINCIPLE INVESTIGATOR: Doctor Pratik Raichurkar, BMed MTrauma(Surgery), Resident Medical Officer, Surgical Outcomes Research Centre (SOuRCe) Royal Prince Alfred Hospital, Sydney, NSW, Australia

Doctor Kilian Brown, MBBS BBiomed MPhil FRACS, Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, NSW, Australia

Doctor Nabila Ansari, BMedSci MBBS FRACS, Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, NSW, Australia

Associate Professor Cherry Koh, MBBS (Hons) MS PhD FRACS, Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, NSW, Australia

Doctor Nima Ahmadi, BSc (Med) Hons, MBBS, MS, FRACS, Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, NSW, Australia

Professor Michael Solomon, MBBCh, BAO(Hons), MSc Cl Epi, DMedSc, DMed, LRCPI, FRACS, FRCSI(Hons) Academic Head Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, NSW, Australia

PRINCIPAL SUPERVISOR: Associate Professor Daniel Steffens, BPhty (Hons) PhD, Director, Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, NSW, Australia

Further Study Information

Current Stage: Ongoing
Date: January 2024 - December 2024
Funding source(s): None


Health Area

Disease Category: Cancer

Disease Name: Colorectal cancer

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review
- Semi structured discussion
- Systematic review

Literature reported outcomes of CRS for CRPM will be identified through a systematic review, while outcomes prioritised by patients and carers will be derived through semi structured interviews. This long list will populate a world-wide Delhi survey, conducted over 2 rounds using a secure online platform. This will be distributed to patients, surgeons, medical oncologists, specialist nurses and allied health staff involved in cytoreductive surgery MDTs worldwide. Items which reach international consensus of importance will be discussed in a face-to-face workshop, with representation from clinicians, patients, and allied health staff. The results of this workshop and Delphi study will inform the development of the final core outcome set.

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