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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2022-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

NCT03567525

Lymphocele After Surgical Procedure

COMPLETED NA

Cold Plasma for the Reduction of Lymphoceles Following PLND

NCT02658851

Lymphoceles Following Pelvic Lymph Node Dissection

COMPLETED NA

Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

NCT03528057

Robotic-Assisted Laparoscopic Partial Nephrectomy Hemostatic Agents Renal Malignant Tumor

WITHDRAWN NA

Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy

NCT01812902

Prostate Cancer

COMPLETED NA

Random Evaluation of Patients Who Have Had Laparoscopic Partial Nephrectomy

NCT04120805

Kidney Cancer

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients are randomized to receive RARP and BPLND, with or without Hemopatch, with an allocation ratio of 1:1.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemopatch

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.

Group Type EXPERIMENTAL

Hemopatch

Intervention Type DEVICE

As stated in Hemopatch arm description

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hemopatch

As stated in Hemopatch arm description

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No