Tumor Rupture During Robotic Partial Nephrectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

robot-assisted partial nephrectomy: Robotic-Assisted Partial Nephrectomy (RAPN) is a minimally invasive surgical procedure performed with the help of a robotic system to remove a kidney tumor while preserving as much healthy kidney tissue as possible. It is commonly used to treat small to medium-sized kidney tumors. Thanks to the precision of robotic technology, RAPN offers faster recovery, less postoperative pain, and fewer complications compared to traditional open surgery.

Study summary

The RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. This event may increase the risk of cancer recurrence or spread, but its true impact is still unclear.

The study includes adult patients who experienced a tumor rupture during RAPN. Researchers will collect data on patient and tumor characteristics, surgical techniques, how the rupture occurred and was managed, and long-term outcomes. Follow-up visits will monitor for recurrence, metastases, and survival for up to five years. No experimental treatments or extra procedures are involved; only standard care is followed.

By analyzing at least 100 cases from various hospitals, the study hopes to clarify whether tumor rupture affects prognosis and to identify risk factors and best practices for managing it. This could help improve patient safety, surgical strategies, and future clinical guidelines. All data are handled confidentially, and participation is voluntary.

Eligibility

Primary outcome measure(s)

• cumulative incidence of recurrences — From date of enrolment until the date of first documented event, assessed up to 60 months
  cumulative incidence of tumor local recurrences (at surgery site)
• Cumulative incidence of Metastases — From date of enrolment until the date of first documented event, assessed up to 60 months
  cumulative incidence of tumor distant metastases
• Cumulative incidence of Cancer-related Deaths — From date of enrolment until the date of first documented event, assessed up to 60 months
  Cumulative incidence of cancer-related deaths (deaths due to the disease). This will be evaluated through cancer-specific survival (CSS)
• Cumulative incidence of All-cause Deaths — From date of enrolment until the date of first documented event, assessed up to 60 months
  Cumulative incidence of non-cancer-related deaths (deaths due to other cause) disease). This will be evaluated through overall survival (OS)

Trial sites (1)

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