Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma of uterine cervix

FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤10mm on conization specimen

FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤50% at pre-conization MRI-scan or "expert" US-scan.

Age ≥18 years

Disqualifiers

Neuroendocrine, clear cell, serous carcinoma

Depth of infiltration >10 mm on conization specimen

Depth of infiltration >50% at pre-conization imaging

Cervical tumor >2 cm

Trial design

Treatments tested in this trial

  • Minimally invasive simple hysterectomy

Treatment groups

974 Participants
are divided into 1 treatment group