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

Inclusion Criteria1

  • 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 Criteria1

  • 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

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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