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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.

NCT07120529 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

Interventions

OTHER

CT scan

CT chest, abdominal, pelvis during follow-up

PROCEDURE

Ultrasound scan (Transvaginal or Transabdominal)

Transvaginal and transabdominal ultrasound scan during follow-up

PROCEDURE

Gynecological examination

Gynecological standard examination during follow-up

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2030-09-01
Completion
2030-12-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120529 on ClinicalTrials.gov