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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSEC-KY-KS-2021-322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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