Long-Term Outcomes of Robot-Assisted Radical Cystectomy:... | NCT05856825 | Trialant
NCT05856825
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
Unknown status
Last Update Posted
May 12, 2023Actual
Enrollment
4,500Estimated
Phase
Not provided
Conditions
Bladder Cancer
Robot-assisted Radical Cystectomy
Interventions
Robot-assisted radical cystectomy
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT05856825
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SYSEC-KY-KS-2021-322
Secondary IDs
Not provided
Brief Title
Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study
Official Title
Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study
Acronym
Not provided
Organization
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER
Status Module
Record Verification Date
May 2023
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Not yet recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 1, 2023Estimated
Primary Completion Date
Dec 31, 2023Estimated
Completion Date
Dec 31, 2023Estimated
First Submitted Date
May 4, 2023
First Submission Date that Met QC Criteria
May 4, 2023
First Posted Date
May 12, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 4, 2023
Last Update Posted Date
May 12, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Bladder Cancer
Robot-assisted Radical Cystectomy
Keywords
Not provided
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
4,500Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Sun Yat-sen Memorial Hospital
Procedure: Robot-assisted radical cystectomy
Renji Hospital, Shanghai Jiaotong University School of Medicine
Procedure: Robot-assisted radical cystectomy
The Third Medical Centre of Chinese PLA General Hospital
Procedure: Robot-assisted radical cystectomy
The First Affiliated Hospital of Zhengzhou University
Procedure: Robot-assisted radical cystectomy
Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College
Procedure: Robot-assisted radical cystectomy
Southwest Hospital, Third Military Medical Hospital (Army Medical University)
Procedure: Robot-assisted radical cystectomy
Tongji Hospital Affiliated to Tongji Medical College Hust
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Robot-assisted radical cystectomy
Procedure
Robot-assisted radical cystectomy
Beijing United Family Hospital and Clinics
Changzheng Hospital, Naval Medical University
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall survival
Time from surgery until death from any cause
Five years
Recurrence-free survival
Time from surgery to tumor recurrence which identified either pathologically or radiographically
Five years
Cancer-specific survival
Time from date of surgery to death due to bladder cancer
Five years
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Patients who underwent robot-assisted radical cystectomy for bladder cancer from 2012 to 2021 in 32 large medical institutions in China.
Sampling Method
Probability Sample
Contacts/Locations Module
Central Contacts
Name
Role
Phone
Extension
Email
Jian Huang, MD
Contact
+86-02034078477
huangj8@mail.sysu.edu.cn
Overall Officials
Not provided
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D001749
Urinary Bladder Neoplasms
Ancestor Terms
ID
Term
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Retrospective
Masking Info
No data available
No data is available for this block.
Procedure: Robot-assisted radical cystectomy
The First Affiliated Hospital of Xi'an Jiaotong University
Procedure: Robot-assisted radical cystectomy
The First Affiliated Hospital of Navy Medical University
Procedure: Robot-assisted radical cystectomy
The First Affiliated Hospital of Nanchang University
Procedure: Robot-assisted radical cystectomy
Zhongda Hospital Southeast University
Procedure: Robot-assisted radical cystectomy
The Second Xiangya Hospital, Central South University
Procedure: Robot-assisted radical cystectomy
The First Affiliated Hospital of Nanjing Medical University
Procedure: Robot-assisted radical cystectomy
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Procedure: Robot-assisted radical cystectomy
Gansu Provincial Hospital
Procedure: Robot-assisted radical cystectomy
The Affiliated Yantai Yuhuangding Hospital of Qingdao University
Procedure: Robot-assisted radical cystectomy
West China Hospital, Sichuan University
Procedure: Robot-assisted radical cystectomy
The First Hospital of China Medical University
Procedure: Robot-assisted radical cystectomy
The Third Xiangya Hospital of Central South University
Procedure: Robot-assisted radical cystectomy
General Hospital of Central Theater Command
Procedure: Robot-assisted radical cystectomy
Kunming First People's Hospital
Procedure: Robot-assisted radical cystectomy
The East Campus of Qingdao Municipal Hospital
Procedure: Robot-assisted radical cystectomy
The second Affiliated Hospital of Kunming Medical University
Procedure: Robot-assisted radical cystectomy
Second Hospital of Dalian Medical University
Procedure: Robot-assisted radical cystectomy
The Second Affiliated Hospital of Xi'an Jiaotong University
Procedure: Robot-assisted radical cystectomy
The First Hospital of Jilin University
Procedure: Robot-assisted radical cystectomy
Zhejiang Cancer Hospital
Procedure: Robot-assisted radical cystectomy
Peking University Third Hospital
Procedure: Robot-assisted radical cystectomy
Changzheng Hospital, Naval Medical University
Procedure: Robot-assisted radical cystectomy
Peking Union Medical College Hospital
Procedure: Robot-assisted radical cystectomy
The First Affiliated Hospital of Chongqing Medical University
Procedure: Robot-assisted radical cystectomy
Beijing United Family Hospital and Clinics
Procedure: Robot-assisted radical cystectomy
Gansu Provincial Hospital
General Hospital of Central Theater Command
Kunming First People's Hospital
Peking Union Medical College Hospital
Peking University Third Hospital
Renji Hospital, Shanghai Jiaotong University School of Medicine
Second Hospital of Dalian Medical University
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Southwest Hospital, Third Military Medical Hospital (Army Medical University)
Sun Yat-sen Memorial Hospital
The Affiliated Yantai Yuhuangding Hospital of Qingdao University
The East Campus of Qingdao Municipal Hospital
The First Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Nanchang University
The First Affiliated Hospital of Nanjing Medical University
The First Affiliated Hospital of Navy Medical University
The First Affiliated Hospital of Xi'an Jiaotong University
The First Affiliated Hospital of Zhengzhou University
The First Hospital of China Medical University
The First Hospital of Jilin University
The Second Affiliated Hospital of Xi'an Jiaotong University
The Second Xiangya Hospital, Central South University
The Third Medical Centre of Chinese PLA General Hospital
The Third Xiangya Hospital of Central South University
The second Affiliated Hospital of Kunming Medical University
Tongji Hospital Affiliated to Tongji Medical College Hust
West China Hospital, Sichuan University
Zhejiang Cancer Hospital
Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College
Zhongda Hospital Southeast University
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications