974
Participants
Start Date
October 27, 2024
Primary Completion Date
July 1, 2027
Study Completion Date
July 1, 2030
Minimally invasive simple hysterectomy
Patients with SHAPE inclusion criteria (FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \< 10 mm on LEEP/cone and \< 50% depth on imaging) should undergo conization with surgical margins free from invasive disease or conization with involved surgical margins followed by MRI scan or expert ultrasound scan showing no residual disease. In case of residual disease at post conization imaging still fitting inclusion criteria, another conization is recommended. After these steps minimally invasive (laparoscopy or robotic) simple hysterectomy is performed with sentinel lymph node biopsy algorithm. Adjuvant therapy is given only in case of positive surgical margins, metastatic lymph nodes, and extensive LVSI with depth of stromal infiltration over 2/3.
RECRUITING
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER