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NCT05856825 Clinical Trial

Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study

Bladder Cancer Clinical Trial

Official title:
Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05856825
Other study ID # SYSEC-KY-KS-2021-322
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date December 31, 2023

Study information
Verified date May 2023
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Jian Huang, MD
Phone +86-02034078477
Email huangj8@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy (RARC) from for bladder cancer in 32 institutions in China were enrolled in this study. Baseline condition, perioperative, pathological, and survival outcome were collected. The study was aimed to report the real-world condition of RARC in China, and evaluate its effectiveness.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4500
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 years old; Clinical stage Ta-T4a/N0-3/M0. Exclusion Criteria: - Severe cardiovascular disease; history of previous major abdominopelvic surgery; patients with distant metastases; medical history of malignancy in other organs.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Robot-assisted radical cystectomy
Robot-assisted radical cystectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Time from surgery until death from any cause Five years
Primary Recurrence-free survival Time from surgery to tumor recurrence which identified either pathologically or radiographically Five years
Primary Cancer-specific survival Time from date of surgery to death due to bladder cancer Five years
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