RecruitingNCT07120529

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.


Sponsor

Medical University of Silesia

Enrollment

300 participants

Start Date

Sep 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing minimally invasive surgery (laparoscopic or robotic) versus open surgery for early-stage cervical cancer (radical hysterectomy). Following concerns raised about minimally invasive approaches in prior research, this study specifically looks at cases where protective surgical techniques were used — such as avoiding a uterine manipulator and using a vaginal cuff protector — to see if outcomes are similar to open surgery. **You may be eligible if...** - You are a woman who had a radical hysterectomy for early-stage cervical cancer (FIGO stages IB1–IIA1, excluding IB3) - Your surgery took place between November 2018 and August 2025 - Your surgical team did not use a uterine manipulator and used a vaginal cuff protective technique **You may NOT be eligible if...** - You had surgery for advanced-stage cervical cancer (FIGO above IIA1) - A uterine manipulator was used during your surgery without the protective maneuver - You had surgery outside the eligible time window Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCT scan

CT chest, abdominal, pelvis during follow-up

PROCEDUREUltrasound scan (Transvaginal or Transabdominal)

Transvaginal and transabdominal ultrasound scan during follow-up

PROCEDUREGynecological examination

Gynecological standard examination during follow-up


Locations(5)

Uniwersyteckie Centrum Onkologii, Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, Poland

Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia

Katowice, Poland

Klinika Ginekologii, Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej

Kielce, Poland

Oddział Ginekologii Onkologicznej z Pododdziałem Urologii, Opolskie Centrum Onkologii

Opole, Poland

Department of Gynaecological Oncology,

Wroclaw, Poland

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NCT07120529


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