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Non-inferiority Trial Omitting Drainage After Robot-assisted Radical prostatectomY
Sponsor: Shanghai East Hospital
Summary
This is a multicenter, prospective, randomized, controlled, open-label, assessor-blinded, non-inferiority trial evaluating whether pelvic drainage can be safely omitted after robot-assisted radical prostatectomy (RARP). A total of 400 patients undergoing RARP for localized or locally advanced prostate cancer (without planned pelvic lymph node dissection) will be randomized 1:1 intraoperatively - after completion of vesicourethral anastomosis with a negative water-tightness test and satisfactory hemostasis - to either no pelvic drain placement (experimental group) or standard pelvic drain placement (control group). The primary outcome is the overall incidence of Clavien-Dindo grade I-V complications within 90 days postoperatively. The non-inferiority margin is set at 10%. Secondary outcomes include major complications, urine leakage/anastomosis-related events, symptomatic pelvic fluid collection or lymphocele, length of hospital stay, 90-day readmission and re-intervention rates, and urinary continence recovery. The hypothesis is that omitting pelvic drainage is non-inferior to routine drainage with respect to 90-day overall complications, while potentially reducing drain-related discomfort and facilitating postoperative recovery.
Official title: Multicenter, Prospective, Randomized Controlled Clinical Study Protocol: Pelvic Drain Placement Versus No Pelvic Drain Placement After Robot-Assisted Radical Prostatectomy
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-10-01
Completion Date
2027-12-31
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
No Pelvic Drain Placement
Omission of prophylactic pelvic drainage after RARP in patients with a water-tight vesicourethral anastomosis, satisfactory hemostasis, and no intraoperative organ injury.
Pelvic Drain Placement
Standard prophylactic pelvic drainage after RARP. The drain is typically removed on postoperative days 1-2 if drainage is low and unremarkable; if drainage is high (e.g., \>100 mL/8h or above the center-specific 24-hour threshold), drain fluid creatinine is measured to rule out urine leakage, and management per prespecified protocol (prolonged drainage, prolonged urethral catheterization, or imaging evaluation) is applied as needed.
Locations (3)
Peking University First Hospital
Beijing, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Shanghai East Hosiptal
Shanghai, China