Condition: Cervical Cancer · Hysterectomy · Sponsor: Medical University of Silesia
The goal of this retrospective observational study with prospective follow-up is to compare the safety and treatment outcomes of radical laparoscopic hysterectomy (removal of the uterus with cervix) versus abdominal (open) hysterectomy performed after the publication of the LACC trial in women with early-stage cervical cancer. Eligible participants will include adult, legally competent women diagnosed with early-stage cervical cancer (FIGO stages IB1-IIA1, excluding FIGO IB3) with negative sentinel lymph node biopsy (SNB) confirmed by ultrastaging. The main questions it aims to answer are: Is there a difference in overall survival (OS) and progression-free survival (PFS) between laparoscopic and abdominal radical hysterectomy? Are postoperative complication rates and recurrence patterns comparable between the two surgical approaches? Researchers will compare outcomes in patients undergoing radical laparoscopic hysterectomy versus abdominal hysterectomy to assess differences in survival, complications, and recurrence. Participants will: Have undergone radical hysterectomy (type B or C per Querleu-Morrow classification), preceded optionally by conization, with the use of uterine manipulators and absence of vaginal cuff protection explicitly excluded; Have had SNB as part of surgical staging; Be followed every 6 months for 5 years; Undergo clinical gynecologic examination and transvaginal and/or transabdominal ultrasound during follow-up; Undergo additional imaging (CT and…
This description comes directly from the study's public registry record.
Krzysztof Nowosielski, professor · +48 502027943 · knowosielski@sum.edu.pl
Always discuss trial participation with your own doctor first.
| Uniwersyteckie Centrum Onkologii, Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok, Poland | Not Yet Recruiting |
| Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia | Katowice, Poland | Recruiting |
| Klinika Ginekologii, Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej | Kielce, Poland | Not Yet Recruiting |
| Oddział Ginekologii Onkologicznej z Pododdziałem Urologii, Opolskie Centrum Onkologii | Opole, Poland | Recruiting |
| Department of Gynaecological Oncology, | Wroclaw, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07120529