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Investigation of the Safety of Robot-assisted Surgery for Malignant Ovarian Tumors

Multi-center Prospective Clinical Study on Robot-assisted Surgery for Malignant Ovarian Tumors (Including Ovarian cancer, Fallopian Tube cancer, Peritoneal Cancer, and Borderline Malignant Tumor)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240220
Enrollment
20
Registered
2024-12-20
Start date
2025-04-18
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Malignant Ovarian cancer Ovarian cancer, Fallopian Tube cancer, Peritoneal Cancer, and Borderline Malignant Tumor

Interventions

a) For preoperative stage I malignant ovarian tumors (including ovarian cancer, fallopian tube cancer, peritoneal cancer, and borderline malignant ovarian tumors) with a tumor diameter of less than 10

Sponsors

Terai Yoshito
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be included: 1. Patients meeting one of the following conditions: a) Preoperative imaging shows a tumor size of less than 10 cm (size that can be collected in a retrieval bag without dissection) with preoperative stage I ovarian malignancy (including ovarian cancer, fallopian tube cancer, peritoneal cancer, or borderline malignant ovarian tumors). b) Previous surgery involved adnexal removal, and postoperative pathology revealed borderline or malignant ovarian cancer (including fallopian tube cancer, peritoneal cancer, or borderline malignant ovarian tumors), indicating the need for additional treatment. c) Preoperative chemotherapy resulted in significant tumor shrinkage to a size deemed resectable (less than 10 cm) or where no obvious lesions remain, with advanced-stage ovarian malignancy (including ovarian cancer, fallopian tube cancer, peritoneal cancer, or borderline malignant ovarian tumors). 2. Patients with an ECOG Performance Status of 0-2. 3. Patients with adequate major organ function. (Clinical tests should be performed within 28 days prior to the planned surgery.) The absolute neutrophil count must be at least 1,500 per cubic millimeter, the platelet count must be at least 100,000 per cubic millimeter, AST (GOT) and ALT (GPT) levels must be 100 IU/L or less, the total serum bilirubin must be less than 1.5 milligrams per deciliter, and serum creatinine must be less than 1.5 milligrams per deciliter. 4. Patients aged 20 years or older at the time of registration (with an upper age limit of 80 years). 5. Patients who have given written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Patients with severe comorbidities. Examples include severe cardiovascular disease or cerebrovascular disorders, diabetes with HbA1c > 8.5% and difficult control, hypertension, pulmonary fibrosis, interstitial pneumonia, bleeding, active peptic ulcer, or severe neurological disorders. 2. Patients with a bleeding tendency. 3. Patients with active multiple cancers. 4. Patients who are predicted to have difficulty completing the study or its follow-up, or who are deemed unsuitable by the principal investigator or sub-investigator. 5. Patients participating in other interventional studies.

Design outcomes

Primary

MeasureTime frame
Intraoperative blood loss

Secondary

MeasureTime frame
Duration of surgery Presence or absence of blood transfusion Presence, type, and severity of intraoperative complications Presence, type, and severity of postoperative complications Postoperative hospital stay Date of admission Date of discharge Completion of robot-assisted surgery Presence or absence of residual tumor Malfunction of the DVSS (Da Vinci Surgical System) Presence, type, and severity of other diseases or conditions

Contacts

Public ContactYuki Sasagawa

Kobe University Hospital

ysasa01@med.kobe-u.ac.jp+81-78-382-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026