Clinical trial · Interventional
Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection
Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Robotic prostatectomy (RARP) is a surgery for treatment localized prostate cancer. Bilateral pelvic lymph node dissection (BPLND) will also be performed if there is an estimated risk of occult nodal metastases exceeding 5%. BPLND in general is a well-tolerated procedure. Lymphatic leak is one of the possible complications after lymph node dissection (BPLND). Lymphocele is a collection of lymphatic fluid after operation. Hemopatch is a material used during operation that may prevent lymphorrhoea. This is a randomizedcontrolled trial that aims at investigating the application of Hemopatch to raw lymphatic tissue in preventing lymphorrhoea. Patients would be divided into 2 groups: with or without the use of Hemopatch during operation. They will be followed up on day 30 to monitor the course of recovery and any complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemopatch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hemopatch
- description
- The RARP and BPLND are performed in the usual manner. Towards the end of the operation, Hemopatch is laid over the ends of raw truncated lymphatic tissue.
- interventionNames
- Device: Hemopatch
- type
- NO_INTERVENTION
- label
- Control
- description
- The RARP and BPLND are performed in the usual manner. Hemopatch will not be applied to control group.
Primary outcomes (1)
- measure
- Total volume of drain output
- timeFrame
- Three days after the allocated treatment
- description
- Cumulative volume of output from the drain
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and above * Able to give informed consent * Suitable for minimally-invasive surgery Exclusion Criteria: * Known allergy or hypersensitivity to any component of Hemopatch® * Known hypersensitivity to bovine proteins or brilliant blue * Patients with prior pelvic radiotherapy * Patients with non-correctable coagulopathy * Patients who are on anticoagulants * Contraindication to general anaesthesia * Previous transurethral resection of the prostate or prostatic surgery * Untreated active infection
References
Publications (5)
- BACKGROUNDMottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25. PMID 27568654
- BACKGROUNDFossati N, Willemse PM, Van den Broeck T, van den Bergh RCN, Yuan CY, Briers E, Bellmunt J, Bolla M, Cornford P, De Santis M, MacPepple E, Henry AM, Mason MD, Matveev VB, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Lam TB, Mottet N, Joniau S. The Benefits and Harms of Different Extents of Lymph Node Dissection During Radical Prostatectomy for Prostate Cancer: A Systematic Review. Eur Urol. 2017 Jul;72(1):84-109. doi: 10.1016/j.eururo.2016.12.003. Epub 2017 Jan 24. PMID 28126351
- BACKGROUNDGilbert DR, Angell J, Abaza R. Evaluation of Absorbable Hemostatic Powder for Prevention of Lymphoceles Following Robotic Prostatectomy With Lymphadenectomy. Urology. 2016 Dec;98:75-80. doi: 10.1016/j.urology.2016.06.071. Epub 2016 Sep 1. PMID 27592524
- BACKGROUNDSimonato A, Varca V, Esposito M, Venzano F, Carmignani G. The use of a surgical patch in the prevention of lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer: a randomized prospective pilot study. J Urol. 2009 Nov;182(5):2285-90. doi: 10.1016/j.juro.2009.07.033. Epub 2009 Sep 16. PMID 19762048
- BACKGROUNDLewis KM, Kuntze CE, Gulle H. Control of bleeding in surgical procedures: critical appraisal of HEMOPATCH (Sealing Hemostat). Med Devices (Auckl). 2015 Dec 22;9:1-10. doi: 10.2147/MDER.S90591. eCollection 2016. PMID 26730213