The safety and efficacy of robot-assisted total pelvic exenteration

JRCT ID: jRCTs022220034

Registered date:12/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal neoplasms, Urogenital neoplasms
• Date of first enrollment: 10/02/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Total pelvic exenteration using da Vinci Xi/X

Outcome(s)

• Primary Outcome: 30-day severe morbidity rate

Secondary Outcome

Operative time
Blood loss
Intraoperative blood use
Postoperative blood use
Postoperative hospital stay
Readmission rate within 30 days after surgery
R0 rate
Rate of conversion to open laparotomy
Intraoperative complication rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically confirmed malignant tumor.
2) Total pelvic exenteration allow curative resection.
3) Eastern Cooperative Oncology Group performance status (PS) 0-1.
4) Age at enrollment must be 20 years or older.
5) Written informed concent.

Exclude criteria

1) Distant metastasis.
2) Difficulty in pneumoperitoneum (severe emphysema, severe heart failure, angle-closure glaucoma).
3) History of clinically serious cardiovascular disease (myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, other thromboembolism, etc.) within 6 months prior to enrollment.
4) Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, liver failure, active infection, etc.).
5) Other patients who are judged by the study physician to be inappropriate for the safe conduct of this study.

Related Information

• Primary Sponsor: Miura Takuya