Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

NARecruitingINTERVENTIONAL
Enrollment

974

Participants

Timeline

Start Date

October 27, 2024

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2030

Conditions
Cervical CancerCervix Cancer
Interventions
PROCEDURE

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.

Trial Locations (1)

Unknown

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER