- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05885204
RARC vs LRC in A Multicenter Cohort Study
May 23, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
3815
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
N/A
Sampling Method
Probability Sample
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
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 |
Intervention / Treatment |
|---|---|
|
Peking University Third Hospital
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
Sun Yat-sen Memorial Hospital
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
Renji Hospital, Shanghai Jiaotong University School of Medicine
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
The Third Medical Centre of Chinese PLA General Hospital
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
The First Affiliated Hospital of Nanchang University
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
Zhongda Hospital Southeast University
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
The Second Xiangya Hospital, Central South University
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
Gansu Provincial Hospital
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
Second Hospital of Dalian Medical University
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic radical cystectomy
|
|
The First Hospital of Jilin University
|
Robot-assisted laparoscopic radical cystectomy
Conventional laparoscopic 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 from bladder cancer.
|
Five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
June 1, 2023
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
May 23, 2023
First Submitted That Met QC Criteria
May 23, 2023
First Posted (Actual)
June 1, 2023
Study Record Updates
Last Update Posted (Actual)
June 1, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSKY-2023-353-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data are not publicly available due to privacy and ethical restrictions.
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.