Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer (SOLUTION2)

A Multicenter Non-inferiority Randomized Controlled Trial on Minimally Invasive Radical Hysterectomy Using an Endoscopic Stapler to Prevent Tumor Spillage in Stage IB2-IIA1 Cervical Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer Stage IB2; Cervical Cancer Stage IIa
• Intervention / Treatment: Device: Open radical hysterectomy; Device: Minimally invasive radical hysterectomy

Detailed Description

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
• Enrollment (Estimated): 494
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Seung Kim, Professor; Phone Number: 82-2-2072-4863; Email: bboddi0311@snu.ac.kr

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University College of Medicine
    • Contact: Hee Seung Kim; Phone Number: 82-2-2072-4863; Email: bboddi0311@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

I. Inclusion Criteria:

1. 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and <4 cm)
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

II. Exclusion Criteria:

1. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open radical hysterectomy; Radical hysterectomy is performed via open surgery	Device: Open radical hysterectomy; Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy
Experimental: Minimally invasive radical hysterectomy; Radical hysterectomy is performed via minimally invasive surgery	Device: Minimally invasive radical hysterectomy; Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 4.5 years after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complcation rate	Proportion of patients experiencing intraoperative complications, including anesthesia-related adverse events, bleeding, organ injury, or other unexpected intraoperative events	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	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	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	Peri-procedural
Estimated blood loss	The approximated volume of blood a patient is believed to have lost during a surgical procedure or an injury.	Peri-procedural
Transfusion requirement	The need for administration of red blood cells to a patient to restore or maintain adequate oxygen-carrying capacity, hemostasis, and blood volume.	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.	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)	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.	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.	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.	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	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.	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.	From date of surgery through 4.5 years postoperatively

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: National Cancer Center, Korea; Samsung Medical Center; Asan Medical Center; Ajou University School of Medicine; SMG-SNU Boramae Medical Center; The Catholic University of Korea; Kangbuk Samsung Hospital; Wonju Severance Christian Hospital; DongGuk University; Keimyung University; Konkuk University; Sinchon Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): June 30, 2035

Study Registration Dates

• First Submitted: October 6, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; complications; survival; postoperative pain; Cervical cancer; perioperative outcomes; recurrence pattern; open radical hysterectomy; minimally invasive radical hysterectomy; endoscopic stapler
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Uterine Cervical Neoplasms
• Other Study ID Numbers: SOLUTION2; 0620202330 (Other Grant/Funding Number: Johnson @ Johnson)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes