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 | Recruiting

• 1 other identifier: BNW/NWN/0052/KB/59/25
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

Brief 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

Cervical Cancer; Hysterectomy

Keywords

cervical cancer; radical laparoscopic hysterectomy; radical abdominal hysterectomy; protective maneuver; LACC study

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival

  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 (3)

• PFS

  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

• Complications

  From enrollment to the 30 and 60 days postoperatively

• Recurrence

  Through study completion, an average of 6 months

Study Arms (2)

RLH

Radical laparoscopic hysterectomy

Other: CT scan; Procedure: Ultrasound scan (Transvaginal or Transabdominal); Procedure: Gynecological examination

RAL

Radical open hysterectomy

Other: CT scan; Procedure: Ultrasound scan (Transvaginal or Transabdominal); Procedure: Gynecological examination

Interventions

CT scan OTHER

CT chest, abdominal, pelvis during follow-up

RAL; RLH

Ultrasound scan (Transvaginal or Transabdominal) PROCEDURE

Transvaginal and transabdominal ultrasound scan during follow-up

RAL; RLH

Gynecological examination PROCEDURE

Gynecological standard examination during follow-up

RAL; RLH

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (5)

Uniwersyteckie Centrum Onkologii, Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, 15-276, Poland

NOT YET RECRUITING

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

Katowice, 40-757, Poland

RECRUITING

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

Kielce, 25-734, Poland

NOT YET RECRUITING

Oddział Ginekologii Onkologicznej z Pododdziałem Urologii, Opolskie Centrum Onkologii

Opole, 45-061, Poland

RECRUITING

Department of Gynaecological Oncology,

Wroclaw, 53-413, Poland

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Krzysztof Nowosielski, professor

CONTACT

+48 502027943; knowosielski@sum.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of recruitment
• Access Criteria: On request

Locations

PL (5)