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

JRCT ID: jRCTs052240220

Registered date:20/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant Ovarian cancer
• Date of first enrollment: 20/12/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

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 cm, the surgical procedure will involve robot-assisted adnexectomy or (simple, modified radical) hysterectomy with bilateral adnexectomy. Specimens will be submitted for intraoperative rapid pathological diagnosis, and depending on the results or case, pelvic and para-aortic lymphadenectomy and partial omentectomy will be added. Lymphadenectomy will be omitted in cases of borderline malignant tumors.

b) For ovarian cancer (including fallopian tube cancer, peritoneal cancer, and borderline malignant ovarian tumors) where adnexectomy was performed and postoperative pathological results indicated borderline malignancy or malignancy, requiring additional treatment, the surgical procedure will involve robot-assisted (simple, modified radical) hysterectomy, resection of the remaining adnexa, pelvic and para-aortic lymphadenectomy, and partial omentectomy. Lymphadenectomy will be omitted in cases of borderline malignant tumors.

c) For advanced malignant ovarian tumors (including ovarian cancer, fallopian tube cancer, peritoneal cancer, and borderline malignant ovarian tumors) where preoperative chemotherapy has been performed, resulting in no obvious lesions or reduction of the tumor to a size deemed resectable (less than 10 cm in diameter as a guideline), the surgical procedure will involve robot-assisted (simple, modified radical) hysterectomy, adnexectomy, and partial omentectomy. In cases of stage IIB or higher without enlarged lymph nodes, retroperitoneal lymphadenectomy will be omitted, similar to open surgery.

Outcome(s)

• Primary Outcome: Intraoperative blood loss

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Terai Yoshito