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Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

RecruitingNAAges 18 Years - anyFemaleFondazione Policlinico Universitario Agostino Gem…
NCT06416748 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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 * Neoadjuvant chemotherapy * Previous pelvic radiotherapy * Pregnant women * Contraindications to surgery * Lymph nodes \>15 mm short axis * Fertility sparing treatment or desire * 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
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What it tests

  • Minimally invasive simple hysterectomy
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Where

1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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