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NCT Number: NCT07256977

Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or 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.

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Key information

Conditions

Cervical Cancer Stage IB2 Cervical Cancer Stage IIa Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

I. Inclusion Criteria:

  • 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
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years
  • Signed and approved consent form

II. Exclusion Criteria:

  • 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
  • Lymph node metastasis (short axis ≥15 mm)
  • Paracervical invasion
  • Bladder or rectal invasion
  • Distant metastasis
  • Prior pelvic or abdominal radiotherapy
  • Prior neoadjuvant chemotherapy before surgery
  • Unsuitable for surgery due to severe systemic disease at the investigator's discretion
  • 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

Treatment and study plan

Open radical hysterectomy

Device

Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy

Minimally invasive radical hysterectomy

Device

Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy

Primary outcomes

  1. 4.5-year progression-free survival rate

    Time frame: Up to 4.5 years after enrollment

    Proportion of patients alive without disease progression or death at 4.5 years after enrollment, as assessed by radiographic imaging and/or clinical criteria

Secondary outcomes

  1. Intraoperative complcation rate

    Time frame: During surgery

    Proportion of patients experiencing intraoperative complications, including anesthesia-related adverse events, bleeding, organ injury, or other unexpected intraoperative events

  2. Postoperative acute complication rate within 4 weeks

    Time frame: Within 4 weeks after surgery

    Proportion of patients experiencing acute postoperative complications within 4 weeks after surgery, including urinary tract infection, cardiopulmonary complications, thromboembolic events, bleeding or organ dysfunction

  3. Postoperative complication rate after 4 weeks

    Time frame: Greater than 4 weeks up to 12 months post-surgery

    Proportion of patients experiencing acute postoperative complications after 4 weeks after surgery, including lymphedema, incisional hernia and dehiscence

  4. Operation time

    Time frame: Peri-procedural

    The total duration of a surgical procedure, specifically measured from the initial surgical incision to the final closure of the wound

  5. Estimated blood loss

    Time frame: Peri-procedural

    The approximated volume of blood a patient is believed to have lost during a surgical procedure or an injury.

  6. Transfusion requirement

    Time frame: From the surgical incision to the end of surgery (skin closure)

    The need for administration of red blood cells to a patient to restore or maintain adequate oxygen-carrying capacity, hemostasis, and blood volume.

  7. Length of hospitalization

    Time frame: From date of hospital admission to date of hospital discharge, assessed up to 30 days.

    The total duration (in days) between a patient's hospital admission and discharge.

  8. Postoperative pain

    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.

    Patient-reported pain intensity measured using a numeric rating scale (0-10)

  9. Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)

    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).

    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.

  10. EQ-5D-5L

    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.

    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.

  11. The 12-item Short Form Health Survey (SF-12)

    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.

    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.

  12. Pelvic Floor Distress Inventory (PFDI)

    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.

    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

  13. 4.5-year overall survival rate

    Time frame: Up to 4.5 years after surgery

    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.

  14. Recurrence pattern at first recurrence

    Time frame: From date of surgery through 4.5 years postoperatively

    Distribution of first recurrence sites categorized as central, pelvic sidewall, and distant metastases. Recurrence must be radiologically or pathologically confirmed.

Study contacts

Contact information is provided by the study sponsor or research team.

Hee Seung Kim, Professor

CONTACT

[email protected]

82-2-2072-4863

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SOLUTION2

Important dates

Study start
2026
Primary completion
2034
Study completion
2035
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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