Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial
Hélène Charbonneau,
Marie Pasquié,
Benoit Peyronnet,
Aurélien Descazeaud,
Nicolas Barry-Delongchamps,
Emmanuel Della Negra,
Romain Mathieu,
Gilles Karsenty,
Jean-Alexandre Long,
Charles Ballereau,
Abdel-Rahmène Azzouzi,
Benjamin Pradère,
Franck Bruyère,
Georges Fournier,
Souhil Lebdai,
Jehanne Calves,
Luc Corbel,
Sébastien Vincendeau,
Gaelle Fiard,
Caroline Thuillier,
Jean-Luc Descotes,
Pierre Colin,
Thibaut Culty,
Audrey Hesbois,
Valerie Fuzier,
Nicolas Savy,
Atul Pathak,
Pierre Albaladejo,
Charles Marc Samama,
Felipe Guerrero,
Vincent Misraï
Affiliations
Hélène Charbonneau
Department of Anesthesia, Clinique Pasteur
Marie Pasquié
Department of Urology, Clinique Pasteur
Benoit Peyronnet
Department of Urology, Rennes University Hospital
Aurélien Descazeaud
Department of Urology, Limoges University Hospital, Dupuytren Hospital
Nicolas Barry-Delongchamps
Department of Urology, Cochin University Hospital
Emmanuel Della Negra
Department of Urology, Clinique Privée des Cotes d’Armor
Romain Mathieu
Department of Urology, Rennes University Hospital
Gilles Karsenty
Department of Urology, Conception Hospital
Jean-Alexandre Long
Department of Urology, Grenoble University Hospital , Michallon Hospital
Charles Ballereau
Department of Urology, Hopital Privée la Louviere
Abdel-Rahmène Azzouzi
Department of Urology, Angers University Hospital
Benjamin Pradère
Department of Urology, Tours University Hospital
Franck Bruyère
Department of Urology, Tours University Hospital
Georges Fournier
Department of Urology, Brest University Hospital, Cavale Blanche Hospital
Souhil Lebdai
Department of Urology, Angers University Hospital
Jehanne Calves
Department of Urology, Brest University Hospital, Cavale Blanche Hospital
Luc Corbel
Department of Urology, Cochin University Hospital
Sébastien Vincendeau
Department of Urology, Rennes University Hospital
Gaelle Fiard
Department of Urology, Grenoble University Hospital , Michallon Hospital
Caroline Thuillier
Department of Urology, Grenoble University Hospital , Michallon Hospital
Jean-Luc Descotes
Department of Urology, Grenoble University Hospital , Michallon Hospital
Pierre Colin
Department of Urology, Hopital Privée la Louviere
Thibaut Culty
Department of Urology, Angers University Hospital
Audrey Hesbois
Department of Anesthesia, Clinique Pasteur
Valerie Fuzier
Department of Anesthesia, Clinique Pasteur
Nicolas Savy
Institute of mathematics, Paul Sabatier University, CNRS
Atul Pathak
Department of Cardiovascular Medicine
Pierre Albaladejo
Department of Anaesthesia and Intensive Care, Grenoble University Hospital
Charles Marc Samama
Department of Anaesthesiology and Intensive Care, Assistance publique-Hôpitaux de Paris, Cochin University Hospital
Felipe Guerrero
Department of Haematology, Toulouse University Hospital
Abstract Background Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. Methods This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score < 2), using two-tailed 95% confidence intervals. Discussion This first multicentre RCT in the field is underway to evaluate the safety and efficacy of PVP in patients with ongoing OAC therapy. The study results could influence the perioperative management of OACs in BPO surgery with a high level of evidence. Trial registration ClinicalTrials.gov, NCT03297281. Registered on 29 September 2017.