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.

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure, Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Poland
Uniwersyteckie Centrum Onkologii, Uniwersytecki Szpital Kliniczny w Białymstoku
NOT_YET_RECRUITING
Bialystok
Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia
RECRUITING
Katowice
Klinika Ginekologii, Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
NOT_YET_RECRUITING
Kielce
Oddział Ginekologii Onkologicznej z Pododdziałem Urologii, Opolskie Centrum Onkologii
RECRUITING
Opole
Department of Gynaecological Oncology,
RECRUITING
Wroclaw
Contact Information
Primary
Krzysztof Nowosielski, professor
knowosielski@sum.edu.pl
+48 502027943
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 300
Treatments
RLH
Radical laparoscopic hysterectomy
RAL
Radical open hysterectomy
Related Therapeutic Areas
Sponsors
Leads: Medical University of Silesia

This content was sourced from clinicaltrials.gov

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