NCT07887321Not yet recruiting
Non-inferiority Trial Omitting Drainage After Robot-assisted Radical prostatectomY
Multicenter, Prospective, Randomized Controlled Clinical Study Protocol: Pelvic Drain Placement Versus No Pelvic Drain Placement After Robot-Assisted Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07887321
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 1 Oct 2026 to the primary completion date, 31 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiotherapy;
- Previous complex pelvic surgery resulting in severe anatomical alteration;
- Requirement for concurrent other major pelvic or abdominal surgery;
Other illness
- Active infection or severe systemic disease unsuitable for study follow-up;
- Any other condition considered by the investigator to make enrollment inappropriate.
Other
- Salvage prostatectomy;
- Uncorrectable coagulopathy;
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shanghai East Hosiptal Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.