This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.
This study exclusively includes patients with stage IB2 or IIA1 cervical cancer who have tumors measuring 2 cm or larger but less than 4 cm. After randomization, one group undergoes radical hysterectomy via open surgery, while the other group undergoes minimally invasive radical hysterectomy using an endoscopic stapler. This approach using an endoscopic stapler aims to prevent intraoperative exposure of tumor cells to the abdominal cavity, comparable to open surgery, thereby enabling a comparison of therapeutic efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
494
Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy
Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy
Seoul National University College of Medicine
Seoul, South Korea
4.5-year progression-free survival rate
Proportion of patients alive without disease progression or death at 4.5 years after enrollment, as assessed by radiographic imaging and/or clinical criteria
Time frame: Up to 4.5 years after enrollment
Intraoperative complcation rate
Proportion of patients experiencing intraoperative complications, including anesthesia-related adverse events, bleeding, organ injury, or other unexpected intraoperative events
Time frame: During surgery
Postoperative acute complication rate within 4 weeks
Proportion of patients experiencing acute postoperative complications within 4 weeks after surgery, including urinary tract infection, cardiopulmonary complications, thromboembolic events, bleeding or organ dysfunction
Time frame: Within 4 weeks after surgery
Postoperative complication rate after 4 weeks
Proportion of patients experiencing acute postoperative complications after 4 weeks after surgery, including lymphedema, incisional hernia and dehiscence
Time frame: Greater than 4 weeks up to 12 months post-surgery
Operation time
The total duration of a surgical procedure, specifically measured from the initial surgical incision to the final closure of the wound
Time frame: Peri-procedural
Estimated blood loss
The approximated volume of blood a patient is believed to have lost during a surgical procedure or an injury.
Time frame: Peri-procedural
Transfusion requirement
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The need for administration of red blood cells to a patient to restore or maintain adequate oxygen-carrying capacity, hemostasis, and blood volume.
Time frame: From the surgical incision to the end of surgery (skin closure)
Length of hospitalization
The total duration (in days) between a patient's hospital admission and discharge.
Time frame: From date of hospital admission to date of hospital discharge, assessed up to 30 days.
Postoperative pain
Patient-reported pain intensity measured using a numeric rating scale (0-10)
Time frame: Assessed at each visit from Visit 2 (2 weeks) and Visit 17 (54 months). The score can range from 0 to 10, with a higher score indicating more severe pain.
Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
Patient-reported quality of life evaluated using the FACT-Cx questionnaire, which includes physical, social/family, emotional, functional well-being, and cervix cancer-specific concerns. The FACT-Cx total score ranges from 0 to 168, with a higher score indicating better quality of life.
Time frame: Assessed at Visit 1(within 4 weeks), Visit 3(2 weeks), Visit 4(6 weeks), Visit 5(3 months), Visit 6(6 months), Visit 10(18 months), Visit 13(30 months), Visit 17(54 months).
EQ-5D-5L
Patient-reported health-related quality of life assessed using the EQ-5D questionnaire, including five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will be converted to index values based on country-specific value sets, and EQ visual analog scale (EQ-VAS) will also be recorded. Higher scores indicate better health status.
Time frame: Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score ranges from -0.594 to 1.000, showing that higher scores mean healthier.
The 12-item Short Form Health Survey (SF-12)
Patient-reported health-related quality of life assessed using the SF-12 questionnaire, which yields Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Higher scores indicate better health status.
Time frame: Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score can range from 0 to 100, with a higher score indicating less severe symptoms.
Pelvic Floor Distress Inventory (PFDI)
Patient-reported pelvic floor dysfunction symptoms assessed using the PFDI questionnaire, which includes subscales for urinary, colorectal-anal, and pelvic organ prolapse symptoms. Higher scores indicate greater symptom distress
Time frame: Assessed at Visit 1 (within 4 weeks), Visit 5 (3 months), Visit 6 (6 months), Visit 10 (18 months), Visit 13 (30 months), Visit 15 (42 months), Visit 17 (54 months). The score can range from 0 to 300, with a higher score indicating more severe symptoms.
4.5-year overall survival rate
Overall survival defined as the time from date of surgery to death from any cause. The 4.5-year survival rate will be estimated using the Kaplan-Meier method. Patients alive at the end of follow-up will be censored at the last known contact.
Time frame: Up to 4.5 years after surgery
Recurrence pattern at first recurrence
Distribution of first recurrence sites categorized as central, pelvic sidewall, and distant metastases. Recurrence must be radiologically or pathologically confirmed.
Time frame: From date of surgery through 4.5 years postoperatively