Actively Recruiting
Comparing Minimally Invasive and Open Radical Hysterectomy in Early Stage Cervical Cancer A Retrospective Study Monitoring Survival and Treatment Outcomes
Led by Medical University of Silesia · Updated on 2025-08-13
300
Participants Needed
5
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing the safety and outcomes of radical laparoscopic hysterectomy versus open abdominal hysterectomy in adult women with early-stage cervical cancer. This retrospective observational study with prospective follow-up focuses on women diagnosed with FIGO stages IB1 to IIA1 cervical cancer, excluding IB3, who have negative sentinel lymph node biopsy confirmed by ultrastaging. The study aims to evaluate differences in overall survival, progression-free survival, postoperative complications, and recurrence patterns between the two surgical approaches. Participants have undergone radical hysterectomy type B or C per Querleu-Morrow classification without the use of uterine manipulators and with protective vaginal cuff closure during surgery. Some may have had preoperative conization. The study compares outcomes of those treated by laparoscopic or open abdominal surgery after the publication of the LACC trial. Follow-up visits occur every 6 months for at least 5 years, with clinical gynecologic exams and ultrasound scans. Additional imaging such as CT and pelvic MRI is performed if symptoms suggest recurrence. During the study, researchers collect data from medical records on survival, recurrence, complications within 30 and 60 days post-surgery, surgery duration, and patient characteristics. Follow-up includes gynecological exams and transvaginal or transabdominal ultrasounds at regular intervals. This study does not involve additional interventions beyond routine care and aims to provide real-world evidence on surgical safety and outcomes in this patient group.
CONDITIONS
Brief Title
Minimally Invasive Surgery Versus Open Radical Hysterectomy in Presumably Early Stage Cervical Cancer: a Retrospective Multicenter Non-inferiority Study Comparing Overall and Progression-free Survival.
Research Team
K
Krzysztof Nowosielski, professor
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