Laparoscopic surgery for ovarian cancer

Not yet recruiting

• Conditions: Ovarian, fallopian tube and peritoneal cancer

• Registration Number: jRCT1070240120

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1. Ovarian cancer judged to be resectable (including fallopian tube cancer, peritoneal cancer and borderline malignant ovarian tumours)
2. Ovarian cancer deemed resectable after preoperative treatment (including fallopian tube cancer, peritoneal cancer and borderline malignant ovarian tumours)
3. Patients with an ECOG performance status of 0 to 2
4. Patients with adequate major organ function. (Laboratory tests must be performed within 28 days prior to scheduled surgery) Neutrophil count > 1,000 /mm3 Platelet count > 100,000 /mm3 AST (GOT), ALT (GPT) less than 100 IU/L Total serum bilirubin less than 1.5 mg/dl Serum creatinine less than 1.5 mg/dl Electrocardiogram within normal limits or asymptomatic and not requiring treatment (in patients without heart disease or serious arrhythmias)

Exclusion Criteria

1. Patients who do not meet the above selection criteria.
2. Patients with serious complications. Examples: serious cardiac or cerebrovascular disease, diabetes or hypertension difficult to control with HbA1c > 8.5%, pulmonary fibrosis, interstitial pneumonia, haemorrhage, active peptic ulcer or serious neurological disease are excluded.
3. Patients who are expected to have difficulty completing the study or follow-up afterwards, or who are deemed unsuitable by the physician in charge.

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Perioperative complications within 30 days of the date of surgery requiring medical intervention