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.
Launched by MEDICAL UNIVERSITY OF SILESIA · Aug 12, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two types of surgery for women with early-stage cervical cancer: a minimally invasive surgery called laparoscopic radical hysterectomy (where the uterus and cervix are removed through small cuts) and the traditional open surgery, where the uterus and cervix are removed through a larger abdominal incision. The main goal is to see if these two surgeries are equally safe and effective by comparing how long women live without the cancer coming back and overall survival. The study also looks at recovery after surgery, including any complications and where the cancer might return if it does.
Women who might be eligible for this study are adults with early-stage cervical cancer who are having a specific type of uterus removal surgery without the use of certain surgical tools (like uterine manipulators) and with careful checking of lymph nodes to make sure cancer hasn’t spread. Participants will be followed for up to five years after surgery with regular check-ups, including pelvic exams and ultrasounds, and additional scans if there are signs of cancer returning. The study collects information about survival, surgery side effects, and cancer recurrence but does not involve any extra treatments beyond standard care. This research aims to help doctors understand which surgical method is best for women in this situation.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Medical University Of Silesia
The Medical University of Silesia is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. Located in Poland, the university is renowned for its commitment to medical education, interdisciplinary collaboration, and the development of new therapeutic approaches. With a focus on translating scientific discoveries into practical applications, the Medical University of Silesia sponsors a range of clinical trials aimed at improving patient outcomes and enhancing the understanding of various medical conditions. Through its rigorous ethical standards and robust research infrastructure, the university plays a pivotal role in shaping the future of medicine both regionally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Białystok, , Poland
Katowice, , Poland
Kielce, , Poland
Opole, , Poland
Wrocław, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported