Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer
NCT ID: NCT07256977
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
494 participants
INTERVENTIONAL
2026-01-01
2035-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer
NCT02368574
Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer
NCT03955185
Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
NCT01649089
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
NCT02562729
Radical Trachelectomy for Women With Early Stage Cervical Cancer
NCT00813007
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Open radical hysterectomy
Radical hysterectomy is performed via open surgery
Open radical hysterectomy
Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy
Minimally invasive radical hysterectomy
Radical hysterectomy is performed via minimally invasive surgery
Minimally invasive radical hysterectomy
Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Open radical hysterectomy
Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy
Minimally invasive radical hysterectomy
Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
3. Planned for Type B or C radical hysterectomy
4. With adequate bone marrow, renal, and hepatic function
* WBC \>3.0 × 10⁹ cells/L
* Platelets \>100 × 10⁹ cells/L
* Creatinine \<180 μmol/L
* Bilirubin \<1.5 × normal range
* AST, ALT \< 3 × normal range
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years
7. Signed and approved consent form
Exclusion Criteria
2. Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
3. The following are observed on preoperative CT or MRI
* Tumor size ≥4 cm
* Lymph node metastasis (short axis ≥15 mm)
* Paracervical invasion
* Bladder or rectal invasion
* Distant metastasis
4. Prior pelvic or abdominal radiotherapy
5. Prior neoadjuvant chemotherapy before surgery
6. Unsuitable for surgery due to severe systemic disease at the investigator's discretion
7. Difficult to consider intraoperative lymphatic mapping due to
* Allergy to triphenylmethane compounds
* History of prior retroperitoneal surgery
* History of prior pelvic radiotherapy
* Cases where cold knife or loop electrosurgical excision procedure (LEEP) was performed within 4 weeks prior to study participation
* Allergy to triphenylmethane compounds
20 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ajou University School of Medicine
OTHER
SMG-SNU Boramae Medical Center
OTHER
Konkuk University
OTHER
DongGuk University
OTHER
Keimyung University
OTHER
National Cancer Center, Korea
OTHER_GOV
The Catholic University of Korea
OTHER
Wonju Severance Christian Hospital
OTHER
Kangbuk Samsung Hospital
OTHER
Asan Medical Center
OTHER
Samsung Medical Center
OTHER
Sinchon Severance Hospital, Yonsei University College of Medicine
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hee Seung Kim
Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University College of Medicine
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0620202330
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SOLUTION2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.