Bladder Cancer Clinical Trial
Official title:
Comparison of the Application of Robot-assisted Laparoscopic Transperitoneal and Transperitoneal Pathways in Radical Cystectomy
Traditional radical cystectomy (RC) is performed transabdominal. However, it often has high postoperative complications. There have been studies on extraperitoneal approach to reduce postoperative complications. Investigators divided participants underwent robot-assisted radical cystectomy into two groups (1:1) . One group of participants transabdominal, the other group extraperitoneal. The incidence of complications and PFS/OS at 3, and 5 years were compared.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2025 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Researchers evaluated patients with muscle invasive bladder cancer or high-risk non-muscular invasive bladder cancer who needed radical cystectomy. 2. Willing to accept the operation and meet the surgical index: a) Absolute count of neutrophils=1.5x109/L; b) Platelets=100×109/L; c) Hemoglobin=90g/L; d) International standardized ratio or activationPartial thrombin time=1.5 Upper limit of normal value (ULN); e) calculated creatinine clearance rate=1 ml/s; f) Total serum bilirubin=1.5×ULN; g) AST, ALT and alkaline phosphatase=2.5×ULN; h) Cardiopulmonary function indicates that it can tolerate major abdominal surgery; 3. None of the pastHistory of abdominal surgery; 4. 18 to 75 years old; 5. ECOG physical state 0 or 1; 6. voluntarily participate in this experiment, be able to provide a written version of the informed consent, and be able to understand and agree to comply with the requirements of this study and the evaluation schedule; Exclusion Criteria: 1. Patients who refuse to receive radical cystectomy 2. Researchers evaluate patients who are unable to tolerate radical cystectomy; 3. There is a abdominal history of surgery; 4. Have had a large-scale operation or major trauma within 28 days before joining the group; 5. Have been vaccinated with live vaccine within 28 days before joining the group; 6. Severe chronic or active infection that requires systemic anti-bacterial, antifungal or antiviral treatment within 14 days before joining the group; 7. Participating in the rest of the clinical research. |
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
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The First Affiliated Hospital with Nanjing Medical University |
China,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complication rate | Complication rate after surgery | through study completion, an average of 1 month, 3 month and 1 year | |
Secondary | OS | Overall Survival | 5 years after surgery | |
Secondary | PFS | progression-free survival | 5 years after surgery |
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