Health TrialsbyHealthPanel

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.

ConditionsCervical CancerHysterectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-85
SponsorMedical University of Silesia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Eligible participants will include adult, legally competent women undergoing surgery for early-stage cervical cancer (FIGO stages IB1-IIA, excluding FIGO IB3) with negative ultrastaging in sentinel node biopsy (SNB). Not using manipulator and vaginal cuff protective maneuver (either by clamping, suture from abdominal or vaginal site or with stapler) are mandatory. SNB might be a first step of the procedure followed by radical hysterectomy type B or C according to the Querleu-Morrow classification. Conization before hysterectomy is optional. Radical hysterectomy is mandatory procedure in inclusion criteria.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • CT scan

    Other intervention

    CT chest, abdominal, pelvis during follow-up

  • Ultrasound scan (Transvaginal or Transabdominal)

    Procedure/Surgery

    Transvaginal and transabdominal ultrasound scan during follow-up

  • Gynecological examination

    Procedure/Surgery

    Gynecological standard examination during follow-up

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: RLH3 interventions
Group B: RAL3 interventions

Trial outcomes

Primary outcomes

1

OS

Overall survival

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary outcomes

1

PFS

Progression-free survival

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
2

Complications

Complication rate based on Clavien-Dindo Classification

Time frame
From enrollment to the 30 and 60 days postoperatively
3

Recurrence

site of the recurrence

Time frame
Through study completion, an average of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Silesia

Lead sponsor

Source ClinicalTrials.gov
Apply now