EUROPEAN UROLOGY 66 (2014) 1092–1100
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Surgery in Motion
A New Robot for Flexible Ureteroscopy: Development and Early Clinical Results (IDEAL Stage 1–2b) Remzi Saglam a, Ahmet Yaser Muslumanoglu b, Zafer Tokatlı a, Turhan C¸as¸kurlu c, Kemal Sarica d, Ali I˙hsan Tas¸c¸i e, Bu¨lent Erkurt f, Evren Su¨er g, Ahmet Sinan Kabakci h, Glenn Preminger i, Olivier Traxer j, Jens J. Rassweiler k,l,* a
Department of Urology, Medicana International Hospital, Ankara, Turkey;
c
Department of Urology, Medeniyet University Hospital, Istanbul, Turkey; d Department of Urology, Kartal Training Hospital, Istanbul, Turkey; e Department
of Urology, Bakırko¨y Training Hospital, Istanbul, Turkey; g i
f
b
Department of Urology, Bagcilar Training Hospital, Istanbul, Turkey;
Department of Urology, Medipol University Medical School Hospital, Istanbul, Turkey;
Department of Urology, Ankara University Medical School Hospital, Ankara, Turkey; h Department of Bioengineering, Hacettepe University, Ankara, Turkey;
Division of Urologic Surgery, Duke University Medical Center, Durham, NC, USA; j Department of Urology, Universite´ Pierre et Marie Curie, Hoˆpital Tenon,
Paris, France; k Department of Urology, SLK Kliniken Heilbronn, Heilbronn, Germany; l Department of Urology, University of Heidelberg, Heidelberg, Germany
Article info
Abstract
Article history: Accepted June 27, 2014
Background: An improved armamentarium has had a significant impact on the emerging role of flexible ureteroscopy (FURS) for the management of nephrolithiasis; however, FURS still represents a challenging technique. Objective: To examine a robotic device designed for FURS for its impact on ergonomics and outcome of the procedure based on the IDEAL (idea, development, evaluation, assessment, long-term study) framework. Design, setting, and participants: Roboflex Avicenna consists of a surgeon’s console and a manipulator for the flexible ureterorenoscope. Following experimental evaluation of the prototype (IDEAL stage 1) and receipt of ethical approval, seven surgeons treated 81 patients (mean age: 42 yr [range: 6–68]) with renal calculi (mean volume: 1296 544 mm3 [range: 432–3100 mm3]) in an observational study (IDEAL stage 2). Surgical procedure: Robotic FURS was performed with the Roboflex Avicenna robotic device. Outcome measurements and statistical analysis: Numerical data were analysed with the Mann-Whitney test, and categorical variables were analysed using the chi-square test or Fisher exact test. P values 6 yr, single and multiple
surgeons preferred a standing position during classic FURS.
[(Fig._4)TD$IG]
2.4.
Statistics
Numerical data were expressed as mean with standard deviation (SD) including range; categorical data were expressed as numbers. SPSS v.15 (IBM Corp, Armonk, NY, USA) was used for data analysis. Categorical variables were analysed using the x2 test (or Fisher exact test). The Mann-Whitney test was used for numeric variables. P values
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Surgery in Motion
A New Robot for Flexible Ureteroscopy: Development and Early Clinical Results (IDEAL Stage 1–2b) Remzi Saglam a, Ahmet Yaser Muslumanoglu b, Zafer Tokatlı a, Turhan C¸as¸kurlu c, Kemal Sarica d, Ali I˙hsan Tas¸c¸i e, Bu¨lent Erkurt f, Evren Su¨er g, Ahmet Sinan Kabakci h, Glenn Preminger i, Olivier Traxer j, Jens J. Rassweiler k,l,* a
Department of Urology, Medicana International Hospital, Ankara, Turkey;
c
Department of Urology, Medeniyet University Hospital, Istanbul, Turkey; d Department of Urology, Kartal Training Hospital, Istanbul, Turkey; e Department
of Urology, Bakırko¨y Training Hospital, Istanbul, Turkey; g i
f
b
Department of Urology, Bagcilar Training Hospital, Istanbul, Turkey;
Department of Urology, Medipol University Medical School Hospital, Istanbul, Turkey;
Department of Urology, Ankara University Medical School Hospital, Ankara, Turkey; h Department of Bioengineering, Hacettepe University, Ankara, Turkey;
Division of Urologic Surgery, Duke University Medical Center, Durham, NC, USA; j Department of Urology, Universite´ Pierre et Marie Curie, Hoˆpital Tenon,
Paris, France; k Department of Urology, SLK Kliniken Heilbronn, Heilbronn, Germany; l Department of Urology, University of Heidelberg, Heidelberg, Germany
Article info
Abstract
Article history: Accepted June 27, 2014
Background: An improved armamentarium has had a significant impact on the emerging role of flexible ureteroscopy (FURS) for the management of nephrolithiasis; however, FURS still represents a challenging technique. Objective: To examine a robotic device designed for FURS for its impact on ergonomics and outcome of the procedure based on the IDEAL (idea, development, evaluation, assessment, long-term study) framework. Design, setting, and participants: Roboflex Avicenna consists of a surgeon’s console and a manipulator for the flexible ureterorenoscope. Following experimental evaluation of the prototype (IDEAL stage 1) and receipt of ethical approval, seven surgeons treated 81 patients (mean age: 42 yr [range: 6–68]) with renal calculi (mean volume: 1296 544 mm3 [range: 432–3100 mm3]) in an observational study (IDEAL stage 2). Surgical procedure: Robotic FURS was performed with the Roboflex Avicenna robotic device. Outcome measurements and statistical analysis: Numerical data were analysed with the Mann-Whitney test, and categorical variables were analysed using the chi-square test or Fisher exact test. P values 6 yr, single and multiple
surgeons preferred a standing position during classic FURS.
[(Fig._4)TD$IG]
2.4.
Statistics
Numerical data were expressed as mean with standard deviation (SD) including range; categorical data were expressed as numbers. SPSS v.15 (IBM Corp, Armonk, NY, USA) was used for data analysis. Categorical variables were analysed using the x2 test (or Fisher exact test). The Mann-Whitney test was used for numeric variables. P values
