NCT05885204

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,815

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2023

Last Update Submit

May 23, 2023

Conditions

Bladder Cancer

Keywords

Bladder cancerRadical cystectomyRobot-assisted laparoscopyConventional laparoscopy

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (10)

Sun Yat-sen Memorial Hospital

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

Renji Hospital, Shanghai Jiaotong University School of Medicine

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

The Third Medical Centre of Chinese PLA General Hospital

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

The First Affiliated Hospital of Nanchang University

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

Peking University Third Hospital

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

The Second Xiangya Hospital, Central South University

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

Zhongda Hospital Southeast University

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

The First Hospital of Jilin University

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

Second Hospital of Dalian Medical University

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

Gansu Provincial Hospital

Procedure: Robot-assisted radical cystectomyProcedure: Conventional laparoscopic radical cystectomy

Interventions

Robot-assisted radical cystectomyPROCEDURE

Robot-assisted laparoscopic radical cystectomy

Gansu Provincial HospitalPeking University Third HospitalRenji Hospital, Shanghai Jiaotong University School of MedicineSecond Hospital of Dalian Medical UniversitySun Yat-sen Memorial HospitalThe First Affiliated Hospital of Nanchang UniversityThe First Hospital of Jilin UniversityThe Second Xiangya Hospital, Central South UniversityThe Third Medical Centre of Chinese PLA General HospitalZhongda Hospital Southeast University
Conventional laparoscopic radical cystectomyPROCEDURE

Conventional laparoscopic radical cystectomy

Gansu Provincial HospitalPeking University Third HospitalRenji Hospital, Shanghai Jiaotong University School of MedicineSecond Hospital of Dalian Medical UniversitySun Yat-sen Memorial HospitalThe First Affiliated Hospital of Nanchang UniversityThe First Hospital of Jilin UniversityThe Second Xiangya Hospital, Central South UniversityThe Third Medical Centre of Chinese PLA General HospitalZhongda Hospital Southeast University

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \>18 years old; Clinical stage Ta-T4a/N0-3/M0

You may not qualify if:

  • Severe cardiovascular disease; History of previous major abdominopelvic surgery; Patients with distant metastases; Medical history of malignancy in other organs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Jian Huang, MD

CONTACT

+86-02034078477huangj8@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 1, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

The data are not publicly available due to privacy and ethical restrictions.