NIPH Clinical Trials Search

Laparoscopic surgery for ovarian cancer

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Ovarian, fallopian tube and peritoneal cancer
Date of first enrollment	01/03/2025
Target sample size	450
Countries of recruitment
Study type	Interventional
Intervention(s)	We perform laparoscopic surgery for ovarian, fallopian tube and peritoneal cancer, which is not yet covered by insurance in Japan.

Outcome(s)

Primary Outcome	Perioperative complications within 30 days of the date of surgery requiring medical intervention
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include 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)
Exclude 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.