Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection

NCT04185922 | Completed

• 1 other identifier: CRE 2019.419
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Prostate cancer; Hemopatch

Outcome Measures

Primary Outcomes (1)

• Total volume of drain output

  Cumulative volume of output from the drain

  Three days after the allocated treatment

Secondary Outcomes (8)

• Operating time

  Immediately post-operative

• Blood loss

  Immediately post-operative

• Duration of drainage

  Three days after the allocated treatment

• Volume of drainage per post-operative day

  Three days after the allocated treatment

• Length of hospital stay

  Three days after the allocated treatment

Study Arms (2)

Hemopatch

EXPERIMENTAL

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.

Device: Hemopatch

Control

NO INTERVENTION

The RARP and BPLND are performed in the usual manner. Hemopatch will not be applied to control group.

Interventions

Hemopatch DEVICE

As stated in Hemopatch arm description

Hemopatch

Eligibility Criteria

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

You may qualify if:

• Age 18 years and above
• Able to give informed consent
• Suitable for minimally-invasive surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (5)

• Mottet 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 BACKGROUND

• Fossati 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 BACKGROUND

• Gilbert 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 BACKGROUND

• Simonato 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 BACKGROUND

• Lewis 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 BACKGROUND

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

Study Officials

• Jeremy Yuen Chun Teoh, MBBS, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are randomized to receive RARP and BPLND, with or without Hemopatch, with an allocation ratio of 1:1.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective; single-centre phase 3 randomised controlled trial conducted to investigate the efficacy of Hemopatch for preventing lymphatic leak after RARP and BPLND.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 4, 2019
• Study Start: February 27, 2020
• Primary Completion: July 21, 2021
• Study Completion: June 10, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)