Actively Recruiting
Minimally Invasive Surgery Versus Open Radical Hysterectomy in Early Stage Cervical Cancer Comparing Overall and Progression-free Survival
Led by Medical University of Silesia · Updated on 2025-08-13
300
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women undergoing radical hysterectomy type B or C per Querleu-Morrow classification for early-stage cervical cancer (FIGO stages IB1 to IIA1, excluding IB3) between November 2018 and August 2025
- Surgery performed without use of a uterine manipulator
- Vaginal cuff protective maneuver used during surgery
- Preoperative conization allowed but optional
- Sentinel lymph node biopsy (SNB) performed as first stage of treatment (optional)
You will not qualify if you...
- Women with advanced stage cervical cancer (FIGO stage above IIA1) or FIGO IB3
- Metastasis detected in sentinel lymph node biopsy confirmed by ultrastaging
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Not willing to participate in the study
- Not willing to undergo CT scans or gynecological examinations during follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Varies (retrospective identification from medical records)
Participants are screened for eligibility to participate in the trial.
No study-specific visits; eligibility determined from past medical records
Duration - Surgery date (retrospective)
Participants underwent radical hysterectomy by either laparoscopic or abdominal approach with specific surgical criteria to prevent tumor spillage.
No study-specific visits; surgery performed as standard care
Duration - At least 5 years
Participants are followed prospectively for a minimum of 5 years to monitor overall and progression-free survival, surgical complications, and recurrence.
Follow-up visits every 6 months including gynecological examination and ultrasound; additional CT scans if symptomatic
Trial Site Locations
Total: 5 locations
1
Uniwersyteckie Centrum Onkologii, Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Poland, 15-276
Not Yet Recruiting
2
Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia
Katowice, Poland, 40-757
Actively Recruiting
3
Klinika Ginekologii, Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
Kielce, Poland, 25-734
Not Yet Recruiting
4
Oddział Ginekologii Onkologicznej z Pododdziałem Urologii, Opolskie Centrum Onkologii
Opole, Poland, 45-061
Actively Recruiting
5
Department of Gynaecological Oncology,
Wroclaw, Poland, 53-413
Actively Recruiting
Research Team
K
Krzysztof Nowosielski, professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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