First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris (TM)): a European prospective multicenter study
Por:
Doizi S, Kamphuis G, Giusti G, Palmero JL, Patterson JM, Proietti S, Straub M, de la Rosette J and Traxer O
Publicada:
1 ago 2017
Ahead of Print:
17 dic 2016
Categoría:
Urology
Resumen:
Purpose We evaluated a new single-use digital flexible cystoscope with
an integrated grasper designed for double-J stent removal, Isiris (TM),
addressing success rate, image quality, deflection, maneuverability and
grasper functionality.
Methods In September 2015, a prospective cohort study was conducted in
six tertiary European reference centers. All consecutive patients
included underwent double-J stent removal and were 18 years or older.
Success rate was defined by complete stent removal. Image quality,
deflection, maneuverability and grasper functionality were rated with a
Likert scale.
Results A total of 83 procedures were performed. 82% of procedures were
performed in the endoscopy room, while the others were in the operating
room since a consecutive endourological intervention was planned. The
median duration of stent implantation was 28 days [14; 60]. In five
patients, stent removal was not possible. Four patients had an incrusted
double-J stent, and in one patient, the stent migrated into the ureter.
After unsuccessful attempts of stent removal with conventional flexible
cystoscope and grasper, the five patients had to be scheduled for an
ureterorenoscopy procedure to remove the stent. In the other 78
patients, all double-J stents were removed successfully. Image quality,
deflection, maneuverability and grasper functionality were rated as
"very good" in 72.3, 78.3, 72.3 and 73.5%, respectively.
Conclusion This multicenter clinical evaluation of Isiris (TM) displayed
good image quality, active deflection, maneuverability and grasper
functionality. Further evaluation of stent removal outcomes, cost
analysis and microbiology will help to delineate the possible place of
Isiris (TM) in the current practice.
Filiaciones:
Doizi S:
Department of Urology, Tenon Hospital, Assistance-Publique Hôpitaux de Paris, 4 rue de la Chine, 75020, Paris, France
Pierre et Marie Curie University, Paris, France
Sorbonne Universités, UPMC Univ Paris 06, AP-HP, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, 4 rue de la Chine, 75020, Paris, France
Kamphuis G:
Department of Urology, Academic Medical Center, Amsterdam, The Netherlands
Giusti G:
Department of Urology, IRCCS San Raffaele Scientific Institute, Ville Turro Division, Milan, Italy
:
Department of Urology, Hospital Universitario La Ribera, Alzira, Valencia, Spain
Patterson JM:
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
Proietti S:
Department of Urology, IRCCS San Raffaele Scientific Institute, Ville Turro Division, Milan, Italy
Straub M:
Department of Urology, Technische Universität München, Munich, Germany
de la Rosette J:
Department of Urology, Academic Medical Center, Amsterdam, The Netherlands
Traxer O:
Department of Urology, Tenon Hospital, Assistance-Publique Hôpitaux de Paris, 4 rue de la Chine, 75020, Paris, France.
Pierre et Marie Curie University, Paris, France.
Sorbonne Universités, UPMC Univ Paris 06, AP-HP, GRC n°20, Groupe de Recherche Clinique sur la Lithiase Urinaire, Hôpital Tenon, 4 rue de la Chine, 75020, Paris, France.
|