Minimally Invasive Simple Hysterectomy for Low-Risk Early Cervical Cancer
Tests the safety of keyhole surgery to remove the womb in early cervical cancer.
Plain-language title generated from the registry record
Registry title: Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT06416748
- Record updated
- 29 October 2024
- Original description
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.Read full original descriptionShow less
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer
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.
Inclusion: 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.
Exclusion: Neoadjuvant chemotherapy; Previous pelvic radiotherapy; Contraindications to surgery; Recurrent cervical cancer; Time between cervical cancer diagnosis and hysterectomy >4 months if conization with tumor negative margins; Time between cervical cancer diagnosis and hysterectomy >3 months if conization with invasive tumor positive margins; 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; Diagnosis on inadvertent hysterectomy; Pregnant women; Lymph nodes >15 mm short axis; Fertility sparing treatment or desire.