Status:
COMPLETED
A Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit
Lead Sponsor:
Sun Yat-sen University
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Nearly half of the complications are related to stoma and ureteroileal anastomosis. The investi...
Detailed Description
The ileal conduit (Bricker) has been used for urinary diversion for more than half a century. Widely accepted to be a simple and safe form of urinary diversion, it remains one of the most commonly use...
Eligibility Criteria
Inclusion
- Age 18-75 years old, gender not limited, life expectancy is greater than or equal to 24 months；
- ECOG score of patients: 0-1；
- Volunteer to participate in this study and sign the informed consent；
- 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;
- Major organ functions, such as liver, kidney, bone marrow, heart and other important organs, were not significantly abnormal: AST, ALT≤2.5 upper limit of normal value (ULN); Total bilirubin (TBIL)≤1.5 ULN; Albumin (ALB)≥25g/L; Serum creatinine (CRE)≤1.5 ULN; Leukocytes≥3.5\*109/L, neutrophils≥1.5\*109/L, hemoglobin≥90g/L, platelets≥80\*109/L; Left ventricular ejection fraction (LVEF) ≥50%; Electrocardiogram showed no obvious abnormality or no clinical significance.
Exclusion
- A history of major middle and lower abdominal surgery;
- Obese patients （BMI≥40kg/m2）;
- Failure to receive regular follow-up review as required;
- Severe cardiovascular disease;
- History of immunodeficiency and organ transplantation；
- History of severe central nervous system disease
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03822234
Start Date
January 15 2019
End Date
March 11 2020
Last Update
April 18 2024
Active Locations (1)
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1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060