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

NCT07256977 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: SOLUTION20620202330
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer Stage IB2; Cervical Cancer Stage IIa

Keywords

Cervical cancer; open radical hysterectomy; minimally invasive radical hysterectomy; endoscopic stapler; survival; complications; perioperative outcomes; postoperative pain; quality of life; recurrence pattern

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Intraoperative complcation rate

  During surgery

• Postoperative acute complication rate within 4 weeks

  Within 4 weeks after surgery

• Postoperative complication rate after 4 weeks

  Greater than 4 weeks up to 12 months post-surgery

• Operation time

  Peri-procedural

• Estimated blood loss

  Peri-procedural

Study Arms (2)

Open radical hysterectomy

EXPERIMENTAL

Radical hysterectomy is performed via open surgery

Device: Open radical hysterectomy

Minimally invasive radical hysterectomy

EXPERIMENTAL

Radical hysterectomy is performed via minimally invasive surgery

Device: Minimally invasive radical hysterectomy

Interventions

Open radical hysterectomy DEVICE

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

Open radical hysterectomy

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

Minimally invasive radical hysterectomy

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• 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

Study Sites (1)

Seoul National University College of Medicine

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hee Seung Kim, Professor

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): June 30, 2035
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)