Safety and efficacy of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer

Safety and efficacy Of minimalLy invasive radical hysterectomy Using an endoscopic sTapler to prevent perItoneal tumOr spIllage in patients with stage IB2 or IIA1 cervical caNcer (SOLUTION 2): a multicenter, open-labeled, non-inferiority, randomized controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0011146

Enrollment

494

Registered

2025-11-12

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : For stage IB2 and IIA1 cervical cancer according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) criteria, when undergoing radical hysterectomy via open su

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women aged 20 years or older 2. FIGO stage IB2 or IIA1 cervical cancer in 2018 (tumor maximum diameter =2 cm and 3.0 X 10? cells/L - Platelets >100 X 10? cells/L - Creatinine <180 µmol/L - Bilirubin <1.5 X normal range - AST, ALT < 3 X normal range 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. No evidence of recurrence for at least 5 years after prior treatment for another invasive malignancy 8. Signature on the approved consent form

Exclusion criteria

Exclusion criteria: 1. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 2. Tumor size less than 2 cm classified as FIGO stage IA1, IA2, or IB1 in 2018 3. Cases where 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. Pelvic or abdominal radiotherapy administered 5. Administration of neoadjuvant chemotherapy prior to surgery 6. Severe systemic disease making them unsuitable for surgery based on the determination of the investigator 7. When intraoperative lymphatic mapping is difficult to consider - Allergy to triphenylmethane compounds - History of prior retroperitoneal surgery - History of prior pelvic radiotherapy - Undergone cervical conization (cold knife or loop electrosurgical excision procedure) within 4 weeks prior to study participation

Design outcomes

Primary

Measure	Time frame
4.5 year-progression-free survival rate	—

Secondary

Measure	Time frame
Incidence rate of intraoperative complincations;Incidence rate of acute postoperative complications;Incidence rate of chronic postoperative complications;Operative time;Estimated blood loss;Number of transfusion;Hospitalization period;Postoperative pain;Functional Assessment of Cancer Therapy-Cervix ;The 12-item Short Form Health Survey ;EuroQol Five Dimension;Pelvic Floor Distress Inventory ;4.5 year-overall survival rate;Pattern of recurrence	—

Measure

Time frame

Incidence rate of intraoperative complincations;Incidence rate of acute postoperative complications;Incidence rate of chronic postoperative complications;Operative time;Estimated blood loss;Number of transfusion;Hospitalization period;Postoperative pain;Functional Assessment of Cancer Therapy-Cervix ;The 12-item Short Form Health Survey ;EuroQol Five Dimension;Pelvic Floor Distress Inventory ;4.5 year-overall survival rate;Pattern of recurrence

—

Countries

Korea, Republic of

Contacts

Public ContactHee Seung Kim

Seoul National University Hospital

bboddi0311@snu.ac.kr+82-2-2072-4863

Outcome results