Tumor Rupture During Robotic Partial Nephrectomy

Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Study ID
NCT07065825
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • robot-assisted partial nephrectomy — PROCEDURE
    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 Details

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.

Key Dates

First listed
Jul 15, 2025
Start date
Sep 30, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Patients who experienced tumor rupture during robotic partial nephrectomy
    Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection)

Primary Outcome Measure

cumulative incidence of recurrences [ Time Frame: From date of enrolment until the date of first documented event, assessed up to 60 months ]

Find similar trials

Nationwide
Kidney cancer trialsOncology trialsUrology trials

Related Studies