Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05856825
• Collaborator: (none)
• Enrollment: 4,500
• Anticipated Duration (Months): 8

Study Details

Study Description

Brief Summary

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.

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 4500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study
• Anticipated Study Start Date: May 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 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
The First Affiliated Hospital of Nanjing Medical 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
Peking University Third 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
The First Affiliated Hospital of Chongqing Medical University	Procedure: Robot-assisted radical cystectomy; Robot-assisted radical cystectomy
Beijing United Family Hospital and Clinics	Procedure: Robot-assisted radical cystectomy; Robot-assisted 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 due to bladder cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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: NCT05856825
• Other Study ID Numbers: SYSEC-KY-KS-2021-322
• First Posted: May 12, 2023
• Last Update Posted: May 12, 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
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of May 12, 2023