RARC vs LRC in A Multicenter Cohort Study

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05885204
• Collaborator: (none)
• Enrollment: 3,815
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Procedure: Robot-assisted radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3815 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Robot-Assisted Versus Conventional Laparoscopic Radical Cystectomy in A Multicenter Cohort Study: A Propensity Score Matching Analysis
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Peking University Third Hospital	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
Zhongda Hospital Southeast 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
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
Gansu Provincial Hospital	Procedure: Robot-assisted radical cystectomy; Robot-assisted laparoscopic radical cystectomy; Procedure: Conventional laparoscopic radical cystectomy; Conventional laparoscopic radical cystectomy

Outcome Measures

Primary Outcome Measures

1. Overall Survival [Five years]

   Time from surgery until death from any cause.

2. Recurrence-free Survival [Five years]

   Time from surgery to tumor recurrence which identified either pathologically or radiographically.

3. Cancer-specific Survival [Five years]

   Time from date of surgery to death from bladder cancer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT05885204
• Other Study ID Numbers: SYSKY-2023-353-01
• First Posted: Jun 1, 2023
• Last Update Posted: Jun 1, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: Bladder cancer; Radical cystectomy; Robot-assisted laparoscopy; Conventional laparoscopy
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Jun 1, 2023