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The safety and efficacy of robot-assisted total pelvic exenteration

The safety and efficacy of robot-assisted total pelvic exenteration using the da Vinci Surgical System - RATPE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs022220034
Enrollment
10
Registered
2022-12-12
Start date
2023-02-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal neoplasms, Urogenital neoplasms Rectal neoplasms, Urogenital neoplasms

Interventions

Total pelvic exenteration using da Vinci Xi/X

Sponsors

Miura Takuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1) Distant metastasis (Not excluded after curative resection of distant metastases). 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.

Design outcomes

Primary

MeasureTime frame
30-day severe morbidity rate

Secondary

MeasureTime frame
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

Contacts

Public ContactTakuya Miura

Hirosaki University Hospital

tmiura@hirosaki-u.ac.jp+81-172-39-5079

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026