Prostate CancerPOND-RARPNCT07887321

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

A study testing No Pelvic Drain Placement and Pelvic Drain Placement in people with Prostate Cancer, run by Shanghai East Hospital at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer
What is being tested?: No Pelvic Drain Placement and Pelvic Drain Placement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 3 sitesChina
Study dates: 1 Oct 2026to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Haifeng Wang, MD contact

021-38804518-26191

kuohaiandrew2000@vip.sina.com

China3 sites

Peking University First Hospital
Beijing
The First Affiliated Hospital of Anhui Medical University
Hefei
Shanghai East Hosiptal
Shanghai

Other trials in China

About this study

Official title: Multicenter, Prospective, Randomized Controlled Clinical Study Protocol: Pelvic Drain Placement Versus No Pelvic Drain Placement After Robot-Assisted Radical Prostatectomy

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
Being tested: No Pelvic Drain Placement, Pelvic Drain Placement
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No Pelvic Drain PlacementProcedure or surgery
Omission of prophylactic pelvic drainage after RARP in patients with a water-tight vesicourethral anastomosis, satisfactory hemostasis, and no intraoperative organ injury.
Pelvic Drain PlacementProcedure or surgery
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.

Study groups in NCT07887321
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Pelvic Drain Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

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%.
Measured: Up to 90 days after surgery.

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1, 3, and 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202631 Dec 2027

First posted21 Oct 2026
Study start1 Oct 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07887321
Sponsor's protocol ID: 2026YS-301
Acronym: POND-RARP
Status last verified: Oct 2026
First submitted: 7 Oct 2026
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared. Study results will be disseminated through publication in peer-reviewed journals and conference presentations.

Publications

EAU Guidelines on Prostate Cancer, Treatment chapter, 2026 https://uroweb.org/guidelines/prostate-cancer/chapter/treatment
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.
PubMed 34410984
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.
PubMed 33457670
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.
PubMed 38155395
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.
PubMed 37014288
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.
PubMed 30398382
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.
PubMed 28872774

Interested in taking part?

Haifeng Wang, MD

021-38804518-26191

kuohaiandrew2000@vip.sina.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Prospective, Randomized Controlled Clinical Study Protocol: Pelvic Drain Placement Versus No Pelvic Drain Placement After Robot-Assisted Radical Prostatectomy
ClinicalTrials.gov ID: NCT07887321
Acronym / sponsor ID: POND-RARP / 2026YS-301
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 400 participants (estimated)
Lead sponsor: Shanghai East HospitalUniversity, hospital or other
Collaborators: Changhai Hospital, The First Affiliated Hospital of Anhui Medical University, Peking University First Hospital
Study start: 1 Oct 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 21 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
No Pelvic Drain Placement (Experimental)	Experimental	Procedure: No Pelvic Drain PlacementPatients 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 PlacementPatients 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.

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No Pelvic Drain PlacementOmission of prophylactic pelvic drainage after RARP in patients with a water-tight vesicourethral anastomosis, satisfactory hemostasis, and no intraoperative organ injury.	Procedure or surgery	No Pelvic Drain Placement (Experimental)
Pelvic Drain PlacementStandard 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.	Procedure or surgery	Pelvic Drain Placement

Primary outcome

Overall incidence of Clavien-Dindo grade I-V complications within 90 days postoperatively
Time frame: 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%.

6 secondary outcomes

Major complication rate (Clavien-Dindo grade ≥ III)
Time frame: Up to 90 days after surgery
Urine leakage or anastomosis-related event rate
Time frame: Perioperative; Postoperative Day 14, Day 30, and Day 90
Symptomatic pelvic fluid collection / lymphocele rate
Time frame: Day 30 and Day 90 after surgery
Postoperative recovery and healthcare resource utilization
Time frame: Up to 90 days after surgery
Urinary continence recovery rate
Time frame: 1, 3, and 12 months after surgery
Score on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
Time frame: 1, 3, and 12 months after surgery

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
BackgroundEAU Guidelines on Prostate Cancer, Treatment chapter, 2026 https://uroweb.org/guidelines/prostate-cancer/chapter/treatment
Results publication: PubMed 34410984Iwamoto 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.
Results publication: PubMed 33457670Su 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.
Results publication: PubMed 38155395Ma 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.
Results publication: PubMed 37014288Yanagisawa 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.
Results publication: PubMed 30398382Porcaro 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.
Results publication: PubMed 28872774Chenam 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.
Individual participant dataSharing planned: No. Individual participant data will not be shared. Study results will be disseminated through publication in peer-reviewed journals and conference presentations.

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MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Haifeng Wang, MD contact

021-38804518-26191

kuohaiandrew2000@vip.sina.com

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing No Pelvic Drain Placement and Pelvic Drain Placement in people with Prostate Cancer, run by Shanghai East Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haifeng Wang, MD (021-38804518-26191, kuohaiandrew2000@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall incidence of Clavien-Dindo grade I-V complications within 90 days postoperatively (time frame: Up to 90 days after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07887321, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.