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

Study Overview
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Brief Summary
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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.

Detailed Description
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In prostate cancer patients undergoing robot-assisted radical prostatectomy (RARP), the current European Association of Urology (EAU) prostate cancer guidelines recommend bilateral pelvic lymph node dissection (BPLND) for those with an estimated risk of occult nodal metastases exceeding 5%.(1) In a systematic review of 66 studies involving 275, 269 patients, lymphadenectomy can identify node positive patients who may benefit from adjuvant treatment (2). BPLND in general is a well-tolerated procedure. However, when complications do occur, significant morbidity results. The benefits of BPLND must be carefully weighed against its potential complications. The most common complication of BPLND is lymphocoele formation. Lymphatic vessels have no muscular layer as opposed to blood vessels. Transection of a blood vessel will lead to vasoconstriction and eventual cessation of bleeding. This is not the case with lymphatic vessels, and transection will lead to prolonged lymphorrhoea. The incidence of lymphocoele varies from series to series, ranging from 0.8% to 33%, depending on the extent of lymphadenectomy, surgical technique, operative approach, and the diagnostic approach (3,4). The most common symptoms are pelvic pain, abdominal distension, lower extremity or scrotal oedema, lower urinary tract symptom, frank bladder outlet obstruction, sepsis and even anastomotic disruption. Prolonged lymphorrhoea lengthens hospital stay, places the patient at risk for nosocomial infection and has significant cost implications for the healthcare system. Hemopatch is a haemostatic pad consisting of a collagen sheet derived from bovine dermis with an NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate) coated active surface. These two components act together to provide effective tissue adherence, sealing and haemostasis (5). Upon tissue contact, NHS-PEG molecules on the active surface form covalent bonds with tissue proteins. Cross-linking NHS-PEG and proteins forms a hydrogel which acts as an effective tissue seal. Older generation NHS-PEG products in the form of solutions of flowable sealants are quickly washed away by blood or other leaking body fluids, rendering them ineffective in the presence of active bleeding or fluid leakage. Hemopatch is a novel NHSPEG delivery vehicle designed to overcome this limitation. Due to the open pore structure of the collagen, excess tissue fluids are readily absorbed and direct contact of NHS-PEG to tissue surface can be achieved. The collagen pad is optimized to be soft, thin, pliable, and has a high liquid absorption capacity. The pad is resorbed and replaced by host tissue in six to eight weeks with little tissue reaction. The investigators hypothesise that the application of Hemopatch to raw lymphatic tissue can prevent lymphorrhoea through its unique combination of tissue adherence, sealing and fluid absorption. This can potentially prevent lymphatic leak, reduce drain output and facilitate earlier discharge.

Official Title
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Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection: a Randomized Controlled Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Hemopatch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemopatch<br>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<br>* As stated in Hemopatch arm description<br>|
| No Intervention: Control<br>The RARP and BPLND are performed in the usual manner. Hemopatch will not be applied to control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of drain output | Cumulative volume of output from the drain | Three days after the allocated treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Duration of operation | Immediately post-operative | 
| Blood loss | Volume of blood loss during operation | Immediately post-operative | 
| Duration of drainage | Number of days between insertion and removal of drain | Three days after the allocated treatment | 
| Volume of drainage per post-operative day | Average volume of drain output per post-operative day | Three days after the allocated treatment | 
| Length of hospital stay | Patients undergoing robotic radical prostatectomy have an average hospital stay of three days | Three days after the allocated treatment | 
| Transfusion requirement | Number of units of packed cells being transfused | Three days after the allocated treatment | 
| Lymph node yield | Number of lymph nodes yielded upon pelvic lymph node dissection | One week after the allocated treatment | 
| 30-day complications | Complications which occur within 30 days after the operation | Thirty days after the allocated treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Hemopatch