Comparing robot-assisted laparoscopic methods for bladder cancer surgery

Comparison of the Application of Robot-assisted Laparoscopic Transperitoneal and Transperitoneal Pathways in Radical Cystectomy

This study is testing if a new robot-assisted surgery for bladder cancer is safer and leads to better recovery than the traditional surgery method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06253091 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of robot-assisted extraperitoneal radical cystectomy compared to traditional transabdominal radical cystectomy in patients with muscle invasive bladder cancer or high-risk non-muscle invasive bladder cancer. Participants will be randomly assigned to one of the two surgical approaches, and the study will evaluate postoperative complications as well as progression-free survival and overall survival rates at 3 and 5 years. The goal is to determine if the extraperitoneal approach offers significant advantages in terms of safety and recovery. The trial aims to enhance surgical outcomes for patients undergoing radical cystectomy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with muscle invasive bladder cancer or high-risk non-muscle invasive bladder cancer who are eligible for radical cystectomy.

Not a fit: Patients with a history of abdominal surgery or those who do not meet the specified health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to fewer postoperative complications and improved recovery for bladder cancer patients.

How similar studies have performed: Previous studies have shown promising results for robot-assisted surgical techniques in urology, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• The first affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yang Xiao Yang, MD

Conditions Bladder Cancer; radical cystectomy