Multicenter, Prospective, Randomized Controlled Clinical Study Protocol: Pelvic Drain Placement Versus No Pelvic Drain Placement After Robot-Assisted Radical Prostatectomy
| Registry | NCT07887321, acronym POND-RARP |
|---|
| Status | Not yet recruiting |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, parallel, masking: single, treatment |
|---|
| Enrollment | 400 (Estimated) |
|---|
| Sponsor | Shanghai East Hospital (Other); collaborators: Changhai Hospital, The First Affiliated Hospital of Anhui Medical University, Peking University First Hospital |
|---|
| Conditions | Prostate Cancer |
|---|
| Interventions | No Pelvic Drain Placement, Pelvic Drain Placement (Procedure) |
|---|
| Dates | start 2026-10-01 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-10-21, last updated 2026-10-21 |
|---|
| Locations | 3 sites in China |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Prostate Cancer All trials of No Pelvic Drain Placement All trials of Pelvic Drain Placement
-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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| No Pelvic Drain Placement (Experimental) | Experimental | Procedure: No Pelvic Drain Placement | 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. |
| Pelvic Drain Placement | Active comparator | Procedure: 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. |
- No Pelvic Drain Placement (Procedure): 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 (Procedure): 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.
+Outcome measures
Primary outcomes
- Overall incidence of Clavien-Dindo grade I-V complications within 90 days postoperatively [Up to 90 days after surgery.]: 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%.
Secondary outcomes
- Major complication rate (Clavien-Dindo grade ≥ III) [Up to 90 days after surgery]: Incidence of Clavien-Dindo grade ≥ III complications within 90 days postoperatively, including events requiring interventional, endoscopic, reoperative, or ICU treatment, or life-threatening events.
- Urine leakage or anastomosis-related event rate [Perioperative; Postoperative Day 14, Day 30, and Day 90]: 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.
- Symptomatic pelvic fluid collection / lymphocele rate [Day 30 and Day 90 after surgery]: 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.
- Postoperative recovery and healthcare resource utilization [Up to 90 days after surgery]: 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.
- Urinary continence recovery rate [1, 3, and 12 months after surgery]: Urinary continence recovery rate, defined as the proportion of participants using 0 pads or 1 security pad per day
- Score on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF) [1, 3, and 12 months after surgery]: Unit of Measure: Score on a scale ranging from 0 to 21; higher scores indicate more severe urinary incontinence
+Eligibility
Sex: Male
Inclusion Criteria:
* Histologically confirmed prostate cancer, life expectancy > 10 years, and planned robot-assisted radical prostatectomy (RARP) as curative treatment;
* Clinically localized or locally advanced prostate cancer with no definite distant metastasis;
* No simultaneous pelvic lymph node dissection (PLND/ePLND) planned, per guideline recommendations and surgeon judgment;
* ECOG performance status score 0-2;
* Able to understand the study content and sign written informed consent;
* Able to complete at least 90 days of postoperative follow-up.
Exclusion Criteria:
* Salvage prostatectomy;
* Previous pelvic radiotherapy;
* Previous complex pelvic surgery resulting in severe anatomical alteration;
* Requirement for concurrent other major pelvic or abdominal surgery;
* Uncorrectable coagulopathy;
* Active infection or severe systemic disease unsuitable for study follow-up;
* Any other condition considered by the investigator to make enrollment inappropriate.
+Locations (3)
| Facility | City | Country | Status |
|---|
| Peking University First Hospital | Beijing | China | |
| The First Affiliated Hospital of Anhui Medical University | Hefei | China | |
| Shanghai East Hosiptal | Shanghai | China | |
+Publications
- EAU Guidelines on Prostate Cancer, Treatment chapter, 2026 https://uroweb.org/guidelines/prostate-cancer/chapter/treatment
- Results publication: Iwamoto H, Kadono Y, Nakagawa R, Makino T, Kadomoto S, Yaegashi H, Iijima M, Kawaguchi S, Nohara T, Shigehara K, Izumi K, Mizokami A. Examination of Necessity for Pelvic Drain Placement After Robot-assisted Radical Prostatectomy. In Vivo. 2021 Sep-Oct;35(5):2895-2899. doi: 10.21873/invivo.12579. PMID 34410984
- Results publication: Su YW, Chang LW, Li JR, Chiu KY, Hung SC. Surgical Drain-Related Intestinal Obstruction After Robot-Assisted Laparoscopic Radical Prostatectomy in Two Cases. J Endourol Case Rep. 2020 Dec 29;6(4):343-347. doi: 10.1089/cren.2020.0121. eCollection 2020. PMID 33457670
- Results publication: Ma J, Chang Y, Xu W, Cao W, Zhang Z, Lou Y, Li D, Ma Z, Jiang J, Ren S. Pelvic drain placement after robot-assisted radical prostatectomy: meta-analysis. BJS Open. 2023 Nov 1;7(6):zrad143. doi: 10.1093/bjsopen/zrad143. PMID 38155395
- Results publication: Yanagisawa T, Kawada T, Mostafaei H, Sari Motlagh R, Quhal F, Laukhtina E, Rajwa P, von Deimling M, Bianchi A, Pallauf M, Pradere B, Karakiewicz PI, Miki J, Kimura T, Shariat SF. Role of pelvic drain and timing of urethral catheter removal following RARP: a systematic review and meta-analysis. BJU Int. 2023 Aug;132(2):132-145. doi: 10.1111/bju.16022. Epub 2023 Apr 20. PMID 37014288
- Results publication: Porcaro AB, Siracusano S, Bizzotto L, Sebben M, Cacciamani GE, de Luyk N, Corsi P, Tafuri A, Processali T, Mattevi D, Cerruto MA, Brunelli M, Novella G, De Marco V, Artibani W. Is a Drain Needed After Robotic Radical Prostatectomy With or Without Pelvic Lymph Node Dissection? Results of a Single-Center Randomized Clinical Trial. J Endourol. 2021 Jun;35(6):922-928. doi: 10.1089/end.2018.0176. Epub 2019 Jul 31. PMID 30398382
- Results publication: Chenam A, Yuh B, Zhumkhawala A, Ruel N, Chu W, Lau C, Chan K, Wilson T, Yamzon J. Prospective randomised non-inferiority trial of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy. BJU Int. 2018 Mar;121(3):357-364. doi: 10.1111/bju.14010. Epub 2017 Sep 22. PMID 28872774
+Study documents