International Snapshot Study on the Outcomes of Retroperitoneal Sarcoma Surgery - SarcomaGroup.org
Introduction: Outcomes of retroperitoneal sarcoma surgery vary upon patient, disease and operation characteristics, as well as center volume and surgeon experience. Furthermore, patients with retroperitoneal sarcoma are presenting at an older age, with more advanced stage sarcomas and more comorbidities which increase the risk of postoperative complications. The aim of SarcomaGroup.org is to identify the true world-wide morbidity and mortality for retroperitoneal sarcoma operations. The secondary aim is to identify modifiable risk factors to improve the outcomes after retroperitoneal sarcoma surgery.
Eligibility: Any surgeon worldwide performing retroperitoneal sarcoma surgery is eligible to participate in SarcomaGroup.org. There are no minimum number of cases to be submitted or selection criteria for centers.
Time period and team members: Each participant may form a team of up to 3 members in total and each center may have more than one team. There will be 6 months of prospective patient enrolment and 3 months follow up within a 12-month frame (January to December 2023).
Inclusion criteria: The following types of retroperitoneal sarcoma surgery will be included:
• All retroperitoneal tumors with suspicion of sarcoma.
• Open, laparoscopic or robotic.
• Elective or emergency.
• All abdominal procedure types (including palliative and radical surgery).
• Procedures with concomitant vascular or other organ resections.
• Adults 18 years of age or older.
Exclusion criteria:
• Gastrointestinal stromal tumors (GIST).
• Desmoid tumors (fibromatosis).
• Open and close procedures.
• Patients less than 18 years of age excluded.
Outcomes: The primary endpoint will be 90-day mortality. Secondary endpoints will be the 90-day post-operative complication rates (Clavien-Dindo and CCI®), length of stay, hospital readmission rates, failure to rescue rates and radicality of the resections.
Data ownership: The headquarters at the Royal Free Hospital in London, UK will act as custodian of the data. The Scientific and Management Committees together will decide, after the publication of the main report, about requests regarding secondary analysis and will consider such requests based on quality and the validity of the proposed project and decide by majority decision. All centers will be able to download their own submitted data in excel format without any need for permission from the study sponsor.
Authorship: A single analysis and reporting without hierarchical authorship (no first author, no last author) is planned at the end of the study (a “pure” group author publication) to reflect the collaborative effort, in keeping with other global snapshot studies. All collaborators will be PubMed cited in the main publication as well as in any future studies. Spin-off studies may include formal authorship but must include the “SarcomaGroup.org Collaborative” citing all participants.
Full protocol: The complete version of the SarcomaGroup.org protocol will be soon available here.