Oversight and monitoring
The study’s regulatory and supervisory functions are managed by the principal investigator (PI) in conjunction with the Coordination Centre for Clinical Trials (KKS) Dresden. The KKS Dresden assumes the data monitoring, which will follow a risk-based approach in line with the ICH-GCP (R2) guidelines. This includes assessing feasibility, availability and completeness of study material, ethics committee approvals, and providing adequate training to local staff. Monitoring activities will also verify written consent forms, source data, and accurate data entries. The frequency of monitoring will be determined based on the assessed risk to maintain data quality and study integrity. A patient advisory council board, comprised of individuals affiliated with the patient self-help organization ILCO, will offer invaluable support to the principal investigator (PI) and the coordinating center by contributing their personal expertise and experience when confronted with challenges that emerge throughout the course of the clinical trial. By implementing these methods, the study aims to minimize bias, ensure rigorous data collection and analysis, and provide a comprehensive and reliable evaluation of the chosen surgical approaches.An independent data and safety monitoring board (DSMB), comprised of members without conflict of interest with the project and study investigators, will conduct regular interim analyses to assess the progress of the study and examine safety variables. The DSMB can terminate the study for safety reasons or due to early superiority, without predefined definitions.