An interventional study of No Pelvic Drain Placement and Pelvic Drain Placement in Prostate Cancer, sponsored by Shanghai East Hospital. Not yet recruiting at 3 sites in China. Open to male participants. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Shanghai East Hospital · Not applicable, Interventional, and Treatment
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 400 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Shanghai East Hospital is the lead sponsor of 94 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients undergo robot-assisted radical prostatectomy (RARP) without pelvic drain placement. The no-drain strategy is executed only after intraoperative confirmation of: (1) completed vesicourethral anastomosis with a negative water-tightness test (120 mL saline), (2) satisfactory hemostasis, and (3) no organ injury. If any criterion is not met, a drain is placed and the patient is excluded from randomization.
Procedure: No Pelvic Drain Placement
Patients undergo robot-assisted radical prostatectomy (RARP) with standard pelvic drain placement. At the end of surgery, a silicone drain is inserted through the abdominal wall under laparoscopic guidance, placed adjacent to the surgical field in the pelvis, secured to the skin with sutures, and connected to a drainage bag.
Procedure: 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.
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.
Overall incidence of Clavien-Dindo grade I-V complications within 90 days postoperatively
The primary endpoint is the occurrence of any Clavien-Dindo grade I-V complication from the end of surgery to postoperative day 90. The non-inferiority margin is set at 10 percentage points (risk difference, no-drain group minus drain group). Non-inferiority will be declared if the upper bound of the two-sided 95% confidence interval of the risk difference is below 10%.
Time frame: Up to 90 days after surgery.
Major complication rate (Clavien-Dindo grade ≥ III)
Incidence of Clavien-Dindo grade ≥ III complications within 90 days postoperatively, including events requiring interventional, endoscopic, reoperative, or ICU treatment, or life-threatening events.
Time frame: Up to 90 days after surgery
Urine leakage or anastomosis-related event rate
Incidence of imaging-confirmed urine leakage, drain fluid creatinine significantly higher than serum creatinine, or prolongation of urethral catheterization, re-catheterization, percutaneous drainage, or other interventions due to suspected or definite anastomotic problems.
Time frame: Perioperative; Postoperative Day 14, Day 30, and Day 90
Symptomatic pelvic fluid collection / lymphocele rate
Incidence of pelvic fluid collection or lymphocele accompanied by pain, fever, infection, lower-limb edema, compressive symptoms, or requiring antibiotics, puncture, catheterization, readmission, or re-intervention.
Time frame: Day 30 and Day 90 after surgery
Postoperative recovery and healthcare resource utilization
Length of postoperative hospital stay (core quantitative indicator), with 90-day readmission rate and re-intervention rate recorded concurrently to explain differences in resource utilization.
Time frame: Up to 90 days after surgery
Urinary continence recovery rate
Urinary continence recovery rate, defined as the proportion of participants using 0 pads or 1 security pad per day
Time frame: 1, 3, and 12 months after surgery
Score on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
Unit of Measure: Score on a scale ranging from 0 to 21; higher scores indicate more severe urinary incontinence
Time frame: 1, 3, and 12 months after surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data will not be shared. Study results will be disseminated through publication in peer-reviewed journals and conference presentations.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's planned 14 months is below that.
Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai East Hospital