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A prospective multicenter randomized controlled clinical study of three ports laparoscopic radical cystectomy and traditional surgery

A prospective multicenter randomized controlled clinical study of three ports laparoscopic radical cystectomy and traditional surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042063
Enrollment
Unknown
Registered
2021-01-13
Start date
2021-04-08
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

Experimental group:3-port laparoscopic radical cystectomy
Control group:5-port laparoscopic radical cystectomy

Sponsors

The Second Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old, life expectancy is greater than or equal to 24 months; 2. Volunteer to participate in this study and sign the informed consent; 3. ECOG score of patients 0-1; 4. T2-T4a, N0-x,M0 invasive bladder cancer; High risk non-muscular invasive bladder cancer T1G3(high grade) tumor; Tis in which BCG therapy failed; Recurrent non-invasive bladder cancer; TUR and bladder perfusion were used for treatment of uncontrolled extensive papillary lesions and bladder non-urothelial carcinoma; 5. Major organ functions, such as liver, kidney, bone marrow, heart and other important organs, were not significantly abnormal: AST, ALT=25g/L; Serum creatinine (CRE)=3.5*10^9/L, neutrophils>=1.5*10^9/L, hemoglobin>=90g/L, platelets>=80*10^9/L; Left ventricular ejection fraction (LVEF) >=50%; Electrocardiogram showed no obvious abnormality or no clinical significance.

Exclusion criteria

Exclusion criteria: 1. A history of major middle and lower abdominal surgery; 2. BMI >= 40kg/m2; 3. Severe cardiovascular disease; 4. History of immunodeficiency and organ transplantation; 5. History of severe central nervous system disease;

Design outcomes

Primary

MeasureTime frame
Tumor radical cure/recurrence;Short-term postoperative complications;Long-term postoperative complications;

Secondary

MeasureTime frame
3 year overall survival and Quality of Life;

Countries

China

Contacts

Public ContactBi Liangkuan

The Second Hospital of Anhui Medical University

biliangkuan@126.com+86 551-65997151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026