Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP) — SOAP  

Benign Prostatic Hyperplasia Clinical Trial

Official title: Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization

Status Recruiting

Clinical Trial Summary

Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine.

For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.

Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.

Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.

No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.

This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.

Clinical Trial Description

SOAP is a non-inferiority, multicentric, open-labelled, two parallel arms study.

The expected benefits are to foster and make the perioperative management of OAC safer in patients undergoing BPH surgery with PVP. ;

Related Conditions & MeSH terms

• Anticoagulant Adverse Reaction
• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

• NCT number: NCT03297281
• Study type: Interventional
• Source: Clinique Pasteur
• Contact: Vincent Misraï, Dr
• Phone: 05 62 21 33 26
• Email: vmisrai@clinique-pasteur.com
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2017
• Completion date: May 31, 2026