Bladder CancerNCT05885204
RARC vs LRC in A Multicenter Cohort Study
An observational study of Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy and laparoscopic radical cystectomy in 10 large medical centers in China were enrolled, comparing the oncologic outcomes of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Robot-assisted radical cystectomy and Conventional laparoscopic radical cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,815 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent robot-assisted radical cystectomy or laparoscopic radical cystectomy for bladder cancer from 2012 to 2021 in 10 large tertiary hospitals
Who may be able to join
- >18 years old; Clinical stage Ta-T4a/N0-3/M0
Who cannot join
- Severe cardiovascular disease; History of previous major abdominopelvic surgery; Patients with distant metastases; Medical history of malignancy in other organs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Robot-Assisted Versus Conventional Laparoscopic Radical Cystectomy in A Multicenter Cohort Study: A Propensity Score Matching Analysis
A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy and laparoscopic radical cystectomy in 10 large medical centers in China were enrolled, comparing the oncologic outcomes of the patients.
- Conditions
- Bladder Cancer
- Being tested
- Robot-assisted radical cystectomy, Conventional laparoscopic radical cystectomy
- Keywords
- Bladder cancer, Radical cystectomy, Robot-assisted laparoscopy, Conventional laparoscopy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted radical cystectomyProcedure or surgery
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomyProcedure or surgery
Conventional laparoscopic radical cystectomy
| Study group | Role | What they receive |
|---|---|---|
| Sun Yat-sen Memorial Hospital | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| The Third Medical Centre of Chinese PLA General Hospital | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| The First Affiliated Hospital of Nanchang University | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| Peking University Third Hospital | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| The Second Xiangya Hospital, Central South University | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| Zhongda Hospital Southeast University | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| The First Hospital of Jilin University | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| Second Hospital of Dalian Medical University | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy | |
| Gansu Provincial Hospital | Not described Receives: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from surgery until death from any cause.
Measured: Five years
Recurrence-free Survival
Time from surgery to tumor recurrence which identified either pathologically or radiographically.
Measured: Five years
Cancer-specific Survival
Time from date of surgery to death from bladder cancer.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,815 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885204
- Sponsor's protocol ID
- SYSKY-2023-353-01
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are not publicly available due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Versus Conventional Laparoscopic Radical Cystectomy in A Multicenter Cohort Study: A Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT05885204
- Acronym / sponsor ID
- SYSKY-2023-353-01
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, Radical cystectomy, Robot-assisted laparoscopy, Conventional laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,815 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy and laparoscopic radical cystectomy in 10 large medical centers in China were enrolled, comparing the oncologic outcomes of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-sen Memorial Hospital | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| The Third Medical Centre of Chinese PLA General Hospital | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| The First Affiliated Hospital of Nanchang University | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| Peking University Third Hospital | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| The Second Xiangya Hospital, Central South University | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| Zhongda Hospital Southeast University | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| The First Hospital of Jilin University | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| Second Hospital of Dalian Medical University | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
| Gansu Provincial Hospital | – | Procedure: Robot-assisted radical cystectomy, Procedure: Conventional laparoscopic radical cystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent robot-assisted radical cystectomy or laparoscopic radical cystectomy for bladder cancer from 2012 to 2021 in 10 large tertiary hospitals
Key inclusion criteria (1 listed)
- >18 years old; Clinical stage Ta-T4a/N0-3/M0
Key exclusion criteria (1 listed)
- Severe cardiovascular disease; History of previous major abdominopelvic surgery; Patients with distant metastases; Medical history of malignancy in other organs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted radical cystectomyRobot-assisted laparoscopic radical cystectomy | Procedure or surgery | Gansu Provincial Hospital, Peking University Third Hospital, Renji Hospital, Shanghai Jiaotong University School of Medicine, Second Hospital of Dalian Medical University, Sun Yat-sen Memorial Hospital, The First Affiliated Hospital of Nanchang University, The First Hospital of Jilin University, The Second Xiangya Hospital, Central South University, The Third Medical Centre of Chinese PLA General Hospital, Zhongda Hospital Southeast University |
| Conventional laparoscopic radical cystectomyConventional laparoscopic radical cystectomy | Procedure or surgery | Gansu Provincial Hospital, Peking University Third Hospital, Renji Hospital, Shanghai Jiaotong University School of Medicine, Second Hospital of Dalian Medical University, Sun Yat-sen Memorial Hospital, The First Affiliated Hospital of Nanchang University, The First Hospital of Jilin University, The Second Xiangya Hospital, Central South University, The Third Medical Centre of Chinese PLA General Hospital, Zhongda Hospital Southeast University |
Primary outcome
Overall Survival
Time frame: Five years
Time from surgery until death from any cause.
Recurrence-free Survival
Time frame: Five years
Time from surgery to tumor recurrence which identified either pathologically or radiographically.
Cancer-specific Survival
Time frame: Five years
Time from date of surgery to death from bladder cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No. The data are not publicly available due to privacy and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Huang, MD (+86-02034078477, huangj8@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Five years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.