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A pilot Study for Novel Single Incision Radical Vulvectomy

A multi-center, single-arm, open-label pilot study for the efficacy and safety of Novel Single Incision Radical Vulvectomy in the treatment of vulvar cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033986
Enrollment
Unknown
Registered
2020-06-20
Start date
2020-06-11
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

Vulvar cancer

Interventions

Case series:Single Incision Radical Vulvectomy

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with primary vulvar carcinoma confirmed by histology, including squamous cell carcinoma of vulva, malignant melanoma of vulva, basal cell carcinoma of vulva, large adenocarcinoma of vestibule of vulva, etc; 2. FIGO stage IB / II / IIIA / IIIB; 3. Patients who underwent radical vulvectomy plus unilateral or bilateral inguinal lymphadenectomy; 4. Platelet >100 * 10^9/L; bilirubin not more than 1.5 times of normal value; alkaline phosphatase not more than 3 times of normal value; ast not more than 3 times of normal value; creatinine not more than 2.0 mg/dl; 5. Patients without contraindications; 6. Patients who voluntarily sign informed consent and are willing to be followed up.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiopulmonary disease or severe mental disorder; 2. Patients with severe coagulation dysfunction; 3. Patients with previous history of inguinal surgery; 4. Patients with ASA score > 3; 5. For other reasons, the researcher thinks it is not suitable to participate in the clinical study.

Design outcomes

Primary

MeasureTime frame
disease free survival rate;overall survival rate;

Secondary

MeasureTime frame
rate of wound-related complications;operative time;bleeding volume;Number of lymph nodes excised;length postoperative hospital stay;cost;

Countries

China

Contacts

Public ContactYifeng Wang

Zhujiang Hospital of Southern Medical University

wyf2015@163.com+86 13825013170

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026