Minimally invasive versus open radical hysterectomy for early-stage cervical cancer
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.
This project tests whether laparoscopic (minimally invasive) radical hysterectomy works as well as open abdominal radical hysterectomy for adult women with early-stage cervical cancer who have negative sentinel lymph nodes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 5 sites (Bialystok and 4 other locations) |
| Trial ID | NCT07120529 on ClinicalTrials.gov |
What this trial studies
This is a retrospective multicenter study with prospective follow-up comparing long-term survival and perioperative outcomes after radical laparoscopic versus open abdominal hysterectomy performed after the LACC trial. Eligible cases are adult women with FIGO 2018 stages IB1–IIA1 (excluding IB3) and negative sentinel lymph nodes confirmed by ultrastaging. The cohort is restricted to surgeries without a uterine manipulator and with a protective vaginal cuff closure maneuver to limit tumor spill. Primary endpoints are overall survival and progression-free survival, with secondary endpoints including perioperative morbidity and recurrence patterns.
Who should consider this trial
Good fit: Ideal candidates are adult, legally competent women with early-stage cervical cancer (FIGO IB1–IIA1, excluding IB3) who had a negative sentinel lymph node biopsy and underwent type B or C radical hysterectomy without a uterine manipulator and with a protective vaginal cuff closure.
Not a fit: Patients with more advanced disease (FIGO >IIA1 or IB3), positive sentinel nodes, poor performance status (ECOG >2), or those unwilling to undergo required imaging and gynecologic follow-up are unlikely to benefit from the comparisons made here.
Why it matters
Potential benefit: If successful, the findings could allow eligible patients to receive minimally invasive hysterectomy with confidence that long-term survival and recurrence risk are similar to open surgery.
How similar studies have performed: A large randomized trial (LACC) reported worse outcomes with minimally invasive radical hysterectomy, while later retrospective series that used protective maneuvers have suggested comparable outcomes, so the approach has mixed and not yet definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Women undergoing radical hysterectomy type B or C according to the Querleu-Morrow classification for early-stage cervical cancer (FIGO stages IB1-IIA1, excluding FIGO IB3 between November 2018 and August 2025 Not using manipulator during surgery Vaginal cuff protective maneuver during surgery Conization before surgery (optional) SNB as a first stage of treatment (optional) Exclusion Criteria: Women undergoing surgery for advanced stage cervical cancer (FIGO \>IIA1) or FIGO IB3 Metastasis detected in sentinel node biopsy (confirmed in ultrastaging) ECOG\>2 Not willing to participate in the study Not willing to undergo CT-scans or gynecological examinations
Where this trial is running
Bialystok and 4 other locations
- 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)
Study contacts
- Study coordinator: Krzysztof Nowosielski, professor
- Email: knowosielski@sum.edu.pl
- Phone: +48 502027943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.