Actively Recruiting

Age: 18Years - 85Years
FEMALE
NCT07120529

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.

Led by Medical University of Silesia · Updated on 2025-08-13

300

Participants Needed

5

Research Sites

271 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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/or pelvic MRI) in case of symptoms suggestive of recurrence. All participants will follow standard post-treatment surveillance. No additional interventions beyond routine follow-up will be performed. Data on OS, PFS, complications (within 30 and 60 days postoperatively, classified by Clavien-Dindo), duration of surgery, recurrence site, and demographic characteristics will be collected.

CONDITIONS

Official 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

Age: 18Years - 85Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women undergoing radical hysterectomy type B or C according to the Querleu-Morrow classification for early-stage cervical cancer (FIGO stages IB1-IIA1, excluding IB3) between November 2018 and August 2025
  • No use of uterine manipulator during surgery
  • Protective vaginal cuff closure maneuver during surgery
  • Optional conization before surgery
  • Sentinel lymph node biopsy performed as first stage of treatment (optional)
Not Eligible

You will not qualify if you...

  • Women undergoing surgery for advanced stage cervical cancer (FIGO stage greater than IIA1) or FIGO IB3
  • Metastasis detected in sentinel lymph node biopsy confirmed by ultrastaging
  • ECOG performance status greater than 2
  • Not willing to participate in the study
  • Not willing to undergo CT scans or gynecological examinations

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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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

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Research Team

K

Krzysztof Nowosielski, professor

CONTACT

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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