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