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Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
NCT06416748 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated 29 Oct 2024
- What is being tested
- Minimally invasive simple hysterectomy
- For
- Cervical Cancer; Cervix Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 974 people. The full rules are on the registry page.
- Where
- Italy
- When
- Starts or started 27 Oct 2024, ends 1 July 2030. Registered 16 May 2024.
- Results
- None posted yet.
In the researchers' words
The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach.
Sites
- Fondazione Policlinico Universitario A. Gemelli IRCCSRoma, Italy