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.
2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and <4 cm)
Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Planned for Type B or C radical hysterectomy
With adequate bone marrow, renal, and hepatic function
Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
The following are observed on preoperative CT or MRI
Tumor size ≥4 cm
Parallel
Open radical hysterectomy
DeviceRadical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy
Minimally invasive radical hysterectomy
DeviceRadical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy
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
Intraoperative complcation rate
Proportion of patients experiencing intraoperative complications, including anesthesia-related adverse events, bleeding, organ injury, or other unexpected intraoperative events
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
Postoperative complication rate after 4 weeks
Proportion of patients experiencing acute postoperative complications after 4 weeks after surgery, including lymphedema, incisional hernia and dehiscence
Operation time
The total duration of a surgical procedure, specifically measured from the initial surgical incision to the final closure of the wound
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Seoul National University Hospital
Lead sponsor
Ajou University School of Medicine
Collaborator
SMG-SNU Boramae Medical Center
Collaborator
Konkuk University
Collaborator
DongGuk University
Collaborator
Keimyung University
Collaborator
National Cancer Center, Korea
Collaborator
The Catholic University of Korea
Collaborator
Wonju Severance Christian Hospital
Collaborator
Kangbuk Samsung Hospital
Collaborator
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator
Sinchon Severance Hospital, Yonsei University College of Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
