RARC vs LRC in A Multicenter Cohort Study

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: Bladder Cancer
• Intervention / Treatment: Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy

• Study Type: Observational
• Enrollment (Estimated): 3815

Contacts and Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peking University Third Hospital	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
Sun Yat-sen Memorial Hospital	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
Renji Hospital, Shanghai Jiaotong University School of Medicine	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
The Third Medical Centre of Chinese PLA General Hospital	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
The First Affiliated Hospital of Nanchang University	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
Zhongda Hospital Southeast University	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
The Second Xiangya Hospital, Central South University	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
Gansu Provincial Hospital	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
Second Hospital of Dalian Medical University	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy
The First Hospital of Jilin University	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 from bladder cancer.	Five years

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

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

• Keywords: Bladder cancer; Radical cystectomy; Conventional laparoscopy; Robot-assisted laparoscopy
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• 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