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

May 4, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Procedure: Robot-assisted radical cystectomy

Study Type

Observational

Enrollment (Anticipated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jian Huang, MD
Phone Number: +86-02034078477
Email: huangj8@mail.sysu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Patients who underwent robot-assisted radical cystectomy for bladder cancer from 2012 to 2021 in 32 large medical institutions in China.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peking University Third Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Affiliated Hospital of Chongqing Medical University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Affiliated Hospital of Nanjing Medical University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Sun Yat-sen Memorial Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Renji Hospital, Shanghai Jiaotong University School of Medicine	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The Third Medical Centre of Chinese PLA General Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Affiliated Hospital of Zhengzhou University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Southwest Hospital, Third Military Medical Hospital (Army Medical University)	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Tongji Hospital Affiliated to Tongji Medical College Hust	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Affiliated Hospital of Xi'an Jiaotong University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Affiliated Hospital of Navy Medical University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Affiliated Hospital of Nanchang University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Zhongda Hospital Southeast University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The Second Xiangya Hospital, Central South University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Gansu Provincial Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The Affiliated Yantai Yuhuangding Hospital of Qingdao University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
West China Hospital, Sichuan University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Hospital of China Medical University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The Third Xiangya Hospital of Central South University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
General Hospital of Central Theater Command	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Kunming First People's Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The East Campus of Qingdao Municipal Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The second Affiliated Hospital of Kunming Medical University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Second Hospital of Dalian Medical University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The Second Affiliated Hospital of Xi'an Jiaotong University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
The First Hospital of Jilin University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Zhejiang Cancer Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Changzheng Hospital, Naval Medical University	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Peking Union Medical College Hospital	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy
Beijing United Family Hospital and Clinics	Procedure: Robot-assisted radical cystectomy Robot-assisted radical cystectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

SYSEC-KY-KS-2021-322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Anticipated)

Contacts and Locations

Study Contact

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Anticipated)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Bladder Cancer

Clinical Trials on Robot-assisted radical cystectomy

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