Non-inferiority Trial Omitting Drainage After Robot-assisted Radical prostatectomY

NCT07887321 | Not Yet Recruiting

• 1 other identifier: 2026YS-301
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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%.

  Up to 90 days after surgery.

Secondary Outcomes (6)

• Major complication rate (Clavien-Dindo grade ≥ III)

  Up to 90 days after surgery

• Urine leakage or anastomosis-related event rate

  Perioperative; Postoperative Day 14, Day 30, and Day 90

• Symptomatic pelvic fluid collection / lymphocele rate

  Day 30 and Day 90 after surgery

• Postoperative recovery and healthcare resource utilization

  Up to 90 days after surgery

• Urinary continence recovery rate

  1, 3, and 12 months after surgery

Study Arms (2)

No Pelvic Drain Placement (Experimental)

EXPERIMENTAL

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

Pelvic Drain Placement

ACTIVE COMPARATOR

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

Interventions

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.

No Pelvic Drain Placement (Experimental)

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.

Pelvic Drain Placement

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Changhai Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Peking University First Hospital: collaborator

Study Sites (3)

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Shanghai East Hosiptal

Shanghai, China

Location

Related Publications (7)

• EAU Guidelines on Prostate Cancer, Treatment chapter, 2026 https://uroweb.org/guidelines/prostate-cancer/chapter/treatment

  BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Haifeng Wang, MD

CONTACT

021-38804518-26191; kuohaiandrew2000@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)