The safety and efficacy of robot-assisted total pelvic exenteratio

Phase 1

Recruiting

• Conditions: Rectal neoplasms, Urogenital neoplasms; D012004, D014565

• Registration Number: JPRN-jRCTs022220034
• Lead Sponsor: Miura Takuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified