Comparing Laparoscopic or Robot-assisted vs Abdominal Radical or Simple Hysterectomy for Early-stage Cervical Cancer

What this Trial Is About

Researchers are evaluating the non-inferiority of minimally invasive radical hysterectomy compared to abdominal radical hysterectomy in patients with early-stage cervical cancer. This prospective, randomized, multicenter trial includes patients with specific cervical cancer types and stages, aiming to compare disease-free survival as the primary outcome. Secondary outcomes include overall survival, disease recurrence, quality of life, complications, and serious adverse events. Participants are randomly assigned to one of two groups the experimental arm receives laparoscopic or robot-assisted radical or simple hysterectomy, while the control arm undergoes abdominal radical or simple hysterectomy. Both arms follow guidelines for lymph node dissection or sentinel lymph node biopsy, with specific protective measures for the minimally invasive approach. Surgery type may vary depending on tumor risk according to SHAPE criteria. During the study, patients will be followed for at least five years after surgery. Assessments include survival outcomes, disease recurrence starting six months post-surgery, quality of life questionnaires, lymphatic side effects, complications, adverse events, and health care cost analysis. Monitoring will continue up to one year for complications and serious adverse events, ensuring comprehensive evaluation of treatment effects and safety over time.

German-funded Laparoscopic Approach to Cervical Cancer