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Ontogeny of a surgical technique: Robotic kidney transplantation with regional hypothermia
International Journal of Surgery 25 (2016) 158e161
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Ontogeny of a surgical technique: Robotic kidney transplantation with regional hypothermia Akshay Sood a, *, 1, Peter McCulloch b, 1, Philipp Dahm c, Rajesh Ahlawat d, Wooju Jeong a, Mahendra Bhandari a, Mani Menon a a
Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA Nuffield Department of Surgery, University of Oxford, Oxford, UK Department of Urology, University of Minnesota, Minneapolis, MN, USA d Kidney and Urology Institute, Medanta e The Medicity, Gurgaon, India b c
h i g h l i g h t s We provide a first-hand account of the evolution of a new surgical procedure. We demonstrate that the evolution of a surgical technique is a continuous process. We however note that the vast majority of changes occur early in the life-cycle of a procedure. Development of a surgical procedure beginning with pre-clinical trial may mitigate patient harm.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 19 July 2015 Received in revised form 13 December 2015 Accepted 17 December 2015 Available online 21 December 2015
Introduction: Innovation is a hallmark of surgical practice. It is generally accepted that a new procedure will undergo technical changes during its evolution; however, quantitative accounts of the process are limited. Methods: Multiple groups, including our own, have recently described a minimally-invasive approach to conventional kidney transplantation (KT) operation. Unique to our experience is a structured development of the technique within the confines of a safe surgical innovation framework e the IDEAL framework (idea, development, exploration, assessment, long-term monitoring; stages 0e4). We here provide a first-hand narrative of the progress of robotic KT operation from preclinical trial to clinical application. Results: Overall, 54 patients underwent robotic KT with regional hypothermia successfully. Major technical changes including selection of optimal patient position (flank vs. lithotomy), robotic instrumentation, vascular occlusion method (bulldog vs. tourniquet) and suture material (prolene vs. GoreTex) occurred early during the procedure development (IDEAL stage 0, preclinical). Minor technical changes such as utilization of the aortic punch for arteriotomy (case 3), use of barbed suture during ureteroneocystostomy (case 6) and extraperitonealization of the graft kidney (case 6) that increased the efficiency and safety of the procedure continued throughout procedure development (IDEAL stages 1e2, clinical stages). Conclusions: We demonstrate that a surgical technique evolves continually; although, the majority of technical alterations occur early in the life-cycle of the procedure. Development of a new technique within the confines a structured surgical innovation framework allows for evidence based progression of the technique and may minimize the risk of harm to the patient. © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
Keywords: Surgical innovation Kidney Transplantation Minimally-invasive IDEAL
* Corresponding author. Vattikuti Urology Institute, Henry Ford Health System, 2799 W. Grand Boulevard, Detroit, MI 48202, USA. E-mail address: [email protected] (A. Sood). 1 Equal contribution. http://dx.doi.org/10.1016/j.ijsu.2015.12.061 1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
A. Sood et al. / International Journal of Surgery 25 (2016) 158e161
1. Introduction 1.1. Surgical innovation is essential for the progress for surgical science We recently described a novel minimally-invasive approach to the traditional open kidney transplantation (KT) operation [1e3], with the idea of minimizing morbidity [4] in the fragile end-stage renal disease patients. To develop the procedure in an evidence based manner, we utilized the IDEAL (idea, development, exploration, assessment and long-term monitoring) model for surgical innovation [5]. In a series of three reports [1e3], we previously described the process we pursued in the discovery of our novel technique of robotic KT (RKT) with regional hypothermia. Briefly, in the first report (stage 0e1) we highlighted the importance of preclinical procedural testing in attaining optimal outcomes starting from the very first patient [1]. The two subsequent reports focused on the surgical technique (stage 2a) [2] and patient safety (stage 1e2a) [3], respectively. However, one aspect that has been lacking in these reports is a detailed description of the technical changes that the procedure underwent (and the effect of these changes on outcomes), from its inception in the cadaver-lab (stage 0) till its standardization in stage 2a. By describing these technical alterations here, we seek to provide a first-hand account of the evolution of a new surgical procedure and hope to impress upon the reader the magnitude of change a technique undergoes in its early days and the importance of structured innovation. 2. Life-cycle of a new procedure Fig. 1 summarizes the technical evolution of RKT with regional hypothermia through different developmental phases. During stage 0, we utilized 2 fresh-frozen cadavers (FFC's) to perform a total of 4 auto-transplants. The FFC dissections were performed at two separate settings to allow for interval review. We started by systematically reviewing the published literature on minimallyinvasive KT. At the time we initiated our stage 0 studies, only two case-reports [6,7] had been published on the subject of RKT. The RKT technique reported by Boggi et al. [6] relied on performance of the ureterovesical anastomosis by open surgery, while in the technique described by Giulianotti et al. [7], all steps were performed robotically. Hence, for our first cadaveric auto-transplant, we faithfully followed the technique described by Giulianotti et al. [7], with one modification. Instead of utilizing the Lap-Disk (Ethicon Inc., OH), we utilized the GelPOINT-platform (Applied Medical Inc., CA), a different hand-access device. GelPOINT allowed easy introduction of the graft kidney, as does Lap-Disk [7], but the key difference was the effortless ice-slush delivery afforded by the GelPOINT without compromising pneumoperitoneum. This assured effective pelvic hypothermia during performance of vascular anastomoses [8]. However, with this set-up, it was not possible to perform ureteroneocystostomy following vascular anastomoses without redocking the robot, as Giulianotti et al. acknowledge [7]. Therefore, in the second auto-transplant we positioned the cadaver in lithotomy with 15 e20 Trendelenburg tilt (as is typical for robotic prostatectomy). The robot was docked in-between the legs. Port placement was also altered to utilise sites similar to robotic prostatectomy [1,8]. The surgery began with bladder dropdown and external-iliac vessels skeletonization. Next, the pelvic bed was cooled with ice-slush and the graft kidney was introduced (both introduced via the GelPOINT). Next, the graft renal vein and artery were anastomosed to the external-iliac vessels in an end-toside continuous manner. Ureteroneocystostomy was performed
159
robotically using the modified Lich-Gregoir technique. With this approach, we could comfortably perform both vascular and ureterovesical anastomoses without needing to reposition the robot. During this dissection, we also tested various robotic instruments, vascular clamps and suture materials. For vascular anastomoses, we tried several combinations of robotic instruments (for e.g. large-needle driver with Maryland grasper or with another large-needle driver or with Black Diamond microforceps) and found the combination of Black Diamond microforceps in the nondominant hand and large-needle driver in the dominant to be most useful. The delicate un-serrated jaws of Black Diamond microforceps allowed meticulous handling of the vessels without traumatizing them, while conversely, the same quality made them unsuitable for holding suture secondary to lack of grip. We also tried different vascular occlusion methods: vessel-loops vs. bulldog-clamps. We noted that bulldog-clamps afforded better occlusion and time efficient application/removal, which would be crucial during vascular anastomoses. Finally, we tested various suture materials: Prolene 6-0 (Ethicon Inc., OH) and GoreTex 50 (Gore Medical Inc., AZ). GoreTex is widely utilized in cardiovascular surgery and we found it to be better suited for robotic vascular anastomoses given its high tensile strength. During the second cadaveric dissection we streamlined our technique (for IDEAL stage 1, our first-in-man operation). Stage 0 therefore permitted us to establish the feasibility of the technique and pelvic cooling. It also allowed us to work out the majority of the nuances of a new procedure (such as patient positioning, instruments, sutures, etc.) in a preclinical setting, thereby, minimizing the harmful effects of learning-curve in patients. In stages 1 (the first 7 patients) and 2a (next 47 patients), the procedure underwent further technical refinements which improved the efficiency (Fig. 1). For example, case-1 onwards, taking cue from open KT, we adopted the use of an ice-gauze jacket which held the ice-slush around the graft kidney and helped maintain local graft hypothermia. Additionally, it allowed atraumatic handling of the graft intracorporeally. The ice-gauze jacket, along with pelvic ice-slush delivered via the GelPOINT, allowed effective graft hypothermia (mean temperature 20.3 C) [1]. This hypothermia presumably translated into improved graft function as the mean discharge creatinine was 1.3 mg/dl in our patients while it was 2 mg/dl in the patients reported by Oberholzer and Giulianotti et al., in whom intracorporeal cooling was not utilized [2,9]. From case-6 onwards, we started extraperitonealizing the graft kidney using the peritoneal flaps raised over the psoas (before this we were simply fixing the graft to the lateral pelvic wall with weck-clips). This insured against graft torsion as Modi et al. [10] demonstrated in their study of laparoscopic KT. Modi et al. [10] noted torsion and loss of graft in 2 out of 6 (33.3%) cases where the graft was left intraperitoneal without fixation, while in the remaining cases, where fixation was performed, there was no torsion. We did not note graft torsion in any patient. Further, intraperitoneal position of the graft has been associated with difficulties in graft biopsy as Oberholzer et al. [9] observed in their study; the patients required open/laparoscopic graft visualization for biopsy. In contrast, in our study, all eleven (20.3%) patients who required graft biopsy could be biopsied percutaneously utilizing routine ultrasound guidance. During this case (case-6) we also improvised our technique of ureteroneocystostomy. Specifically, we started utilizing the barbed V-LOC CV23 suture (Covidien Inc., MA) for detrusor tunnel closure. This decreased the ureterovesical ureteroneocystostomy from 26-min to 15-min without compromising the anastomosis quality. Lastly, during stage 2a of procedure development, not surprisingly, only a few minor modifications occurred. The effects of all alterations are summarized in Fig. 1.
160
A. Sood et al. / International Journal of Surgery 25 (2016) 158e161
Fig. 1. Technical evolution of robotic kidney transplantation (RKT) with regional hypothermia through different stages of the IDEAL model [Y-axis lists the steps in RKT and the Xaxis represents progression of cases through the phases of IDEAL; the technical and/or functional effects of various modifications are listed systematically alongside the corresponding modification].
3. Conclusions The evolution of a surgical technique is a continuous process; however, the vast majority of changes occur early in the life-cycle of a procedure. Further, developing a procedure in a structured manner, starting with preclinical testing is “ideal” as this allows for majority of the technical nuances to be worked out prior to patient surgery, thereby, minimizing patient harm. Lastly, the importance of record keeping should not be ignored as it is only by meticulous record keeping that we can estimate the effect of various
alterations, however small, in a prospective manner, and ensure that other surgeons can benefit from our experience. We encourage other surgical innovators to adopt the IDEAL recommendations to generate high quality research evidence.
Ethical approval Medanta Hospital Institutional Review Board approved the study.
A. Sood et al. / International Journal of Surgery 25 (2016) 158e161
Funding None.
[3]
Author contribution [4]
Writing: AS, PM, PD, RA, WJ, MB, MM. Data collection: AS. Data analysis: AS. Supervision: PM, MB, MM. Logistic Support: RA, MB, MM.
[5]
[6]
Conflicts of interest [7]
None. Guarantor
[8]
Akshay Sood. References [1] M. Menon, R. Abaza, A. Sood, R. Ahlawat, K.R. Ghani, W. Jeong, et al., Robotic kidney transplantation with regional hypothermia: evolution of a novel procedure utilizing the IDEAL guidelines (IDEAL phase 0 and 1), Eur. Urol. 65 (2014) 1001e1009. [2] M. Menon, A. Sood, M. Bhandari, V. Kher, P. Ghosh, R. Abaza, et al., Robotic
[9]
[10]
161
kidney transplantation with regional hypothermia: a step-by-step description of the Vattikuti urology Institute-Medanta technique (IDEAL phase 2a), Eur. Urol. 65 (2014) 991e1000. A. Sood, K.R. Ghani, R. Ahlawat, P. Modi, R. Abaza, W. Jeong, et al., Application of the statistical process control method for prospective patient safety monitoring during the learning phase: robotic kidney transplantation with regional hypothermia (IDEAL phase 2a-b), Eur. Urol. 66 (2014) 371e378. Q.D. Trinh, J. Sammon, M. Sun, P. Ravi, K.R. Ghani, M. Bianchi, et al., Perioperative outcomes of robot-assisted radical prostatectomy compared with open radical prostatectomy: results from the nationwide inpatient sample, Eur. Urol. 61 (2012) 679e685. P. McCulloch, D.G. Altman, W.B. Campbell, D.R. Flum, P. Glasziou, J.C. Marshall, et al., No surgical innovation without evaluation: the IDEAL recommendations, Lancet 374 (2009) 1105e1112. U. Boggi, F. Vistoli, S. Signori, S. D'Imporzano, G. Amorese, G. Consani, et al., Robotic renal transplantation: first European case, Transpl. Int. Off. J. Eur. Soc. Organ Transplant. 24 (2011) 213e218. P. Giulianotti, V. Gorodner, F. Sbrana, I. Tzvetanov, H. Jeon, F. Bianco, et al., Robotic transabdominal kidney transplantation in a morbidly obese patient, Am. J. Transplant. Off. J. Am. Soc. Transplant. Am. Soc. Transpl. Surg. 10 (2010) 1478e1482. W. Jeong, A. Sood, K.R. Ghani, D. Pucheril, J.D. Sammon, N.S. Gupta, et al., Bimanual examination of the retrieved specimen and regional hypothermia during robot-assisted radical prostatectomy: a novel technique for reducing positive surgical margin and achieving pelvic cooling, BJU Int. 114 (2014) 955e957. J. Oberholzer, P. Giulianotti, K.K. Danielson, M. Spaggiari, L. Bejarano-Pineda, F. Bianco, et al., Minimally invasive robotic kidney transplantation for obese patients previously denied access to transplantation, Am. J. Transplant. Off. J. Am. Soc. Transplant. Am. Soc. Transpl. Surg. 13 (2013) 721e728. P. Modi, B. Pal, J. Modi, S. Singla, C. Patel, R. Patel, et al., Retroperitoneoscopic living-donor nephrectomy and laparoscopic kidney transplantation: experience of initial 72 cases, Transplantation 95 (2013) 100e105.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Ontogeny of a surgical technique: Robotic kidney transplantation with regional hypothermia Akshay Sood a, *, 1, Peter McCulloch b, 1, Philipp Dahm c, Rajesh Ahlawat d, Wooju Jeong a, Mahendra Bhandari a, Mani Menon a a
Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA Nuffield Department of Surgery, University of Oxford, Oxford, UK Department of Urology, University of Minnesota, Minneapolis, MN, USA d Kidney and Urology Institute, Medanta e The Medicity, Gurgaon, India b c
h i g h l i g h t s We provide a first-hand account of the evolution of a new surgical procedure. We demonstrate that the evolution of a surgical technique is a continuous process. We however note that the vast majority of changes occur early in the life-cycle of a procedure. Development of a surgical procedure beginning with pre-clinical trial may mitigate patient harm.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 19 July 2015 Received in revised form 13 December 2015 Accepted 17 December 2015 Available online 21 December 2015
Introduction: Innovation is a hallmark of surgical practice. It is generally accepted that a new procedure will undergo technical changes during its evolution; however, quantitative accounts of the process are limited. Methods: Multiple groups, including our own, have recently described a minimally-invasive approach to conventional kidney transplantation (KT) operation. Unique to our experience is a structured development of the technique within the confines of a safe surgical innovation framework e the IDEAL framework (idea, development, exploration, assessment, long-term monitoring; stages 0e4). We here provide a first-hand narrative of the progress of robotic KT operation from preclinical trial to clinical application. Results: Overall, 54 patients underwent robotic KT with regional hypothermia successfully. Major technical changes including selection of optimal patient position (flank vs. lithotomy), robotic instrumentation, vascular occlusion method (bulldog vs. tourniquet) and suture material (prolene vs. GoreTex) occurred early during the procedure development (IDEAL stage 0, preclinical). Minor technical changes such as utilization of the aortic punch for arteriotomy (case 3), use of barbed suture during ureteroneocystostomy (case 6) and extraperitonealization of the graft kidney (case 6) that increased the efficiency and safety of the procedure continued throughout procedure development (IDEAL stages 1e2, clinical stages). Conclusions: We demonstrate that a surgical technique evolves continually; although, the majority of technical alterations occur early in the life-cycle of the procedure. Development of a new technique within the confines a structured surgical innovation framework allows for evidence based progression of the technique and may minimize the risk of harm to the patient. © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
Keywords: Surgical innovation Kidney Transplantation Minimally-invasive IDEAL
* Corresponding author. Vattikuti Urology Institute, Henry Ford Health System, 2799 W. Grand Boulevard, Detroit, MI 48202, USA. E-mail address: [email protected] (A. Sood). 1 Equal contribution. http://dx.doi.org/10.1016/j.ijsu.2015.12.061 1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
A. Sood et al. / International Journal of Surgery 25 (2016) 158e161
1. Introduction 1.1. Surgical innovation is essential for the progress for surgical science We recently described a novel minimally-invasive approach to the traditional open kidney transplantation (KT) operation [1e3], with the idea of minimizing morbidity [4] in the fragile end-stage renal disease patients. To develop the procedure in an evidence based manner, we utilized the IDEAL (idea, development, exploration, assessment and long-term monitoring) model for surgical innovation [5]. In a series of three reports [1e3], we previously described the process we pursued in the discovery of our novel technique of robotic KT (RKT) with regional hypothermia. Briefly, in the first report (stage 0e1) we highlighted the importance of preclinical procedural testing in attaining optimal outcomes starting from the very first patient [1]. The two subsequent reports focused on the surgical technique (stage 2a) [2] and patient safety (stage 1e2a) [3], respectively. However, one aspect that has been lacking in these reports is a detailed description of the technical changes that the procedure underwent (and the effect of these changes on outcomes), from its inception in the cadaver-lab (stage 0) till its standardization in stage 2a. By describing these technical alterations here, we seek to provide a first-hand account of the evolution of a new surgical procedure and hope to impress upon the reader the magnitude of change a technique undergoes in its early days and the importance of structured innovation. 2. Life-cycle of a new procedure Fig. 1 summarizes the technical evolution of RKT with regional hypothermia through different developmental phases. During stage 0, we utilized 2 fresh-frozen cadavers (FFC's) to perform a total of 4 auto-transplants. The FFC dissections were performed at two separate settings to allow for interval review. We started by systematically reviewing the published literature on minimallyinvasive KT. At the time we initiated our stage 0 studies, only two case-reports [6,7] had been published on the subject of RKT. The RKT technique reported by Boggi et al. [6] relied on performance of the ureterovesical anastomosis by open surgery, while in the technique described by Giulianotti et al. [7], all steps were performed robotically. Hence, for our first cadaveric auto-transplant, we faithfully followed the technique described by Giulianotti et al. [7], with one modification. Instead of utilizing the Lap-Disk (Ethicon Inc., OH), we utilized the GelPOINT-platform (Applied Medical Inc., CA), a different hand-access device. GelPOINT allowed easy introduction of the graft kidney, as does Lap-Disk [7], but the key difference was the effortless ice-slush delivery afforded by the GelPOINT without compromising pneumoperitoneum. This assured effective pelvic hypothermia during performance of vascular anastomoses [8]. However, with this set-up, it was not possible to perform ureteroneocystostomy following vascular anastomoses without redocking the robot, as Giulianotti et al. acknowledge [7]. Therefore, in the second auto-transplant we positioned the cadaver in lithotomy with 15 e20 Trendelenburg tilt (as is typical for robotic prostatectomy). The robot was docked in-between the legs. Port placement was also altered to utilise sites similar to robotic prostatectomy [1,8]. The surgery began with bladder dropdown and external-iliac vessels skeletonization. Next, the pelvic bed was cooled with ice-slush and the graft kidney was introduced (both introduced via the GelPOINT). Next, the graft renal vein and artery were anastomosed to the external-iliac vessels in an end-toside continuous manner. Ureteroneocystostomy was performed
159
robotically using the modified Lich-Gregoir technique. With this approach, we could comfortably perform both vascular and ureterovesical anastomoses without needing to reposition the robot. During this dissection, we also tested various robotic instruments, vascular clamps and suture materials. For vascular anastomoses, we tried several combinations of robotic instruments (for e.g. large-needle driver with Maryland grasper or with another large-needle driver or with Black Diamond microforceps) and found the combination of Black Diamond microforceps in the nondominant hand and large-needle driver in the dominant to be most useful. The delicate un-serrated jaws of Black Diamond microforceps allowed meticulous handling of the vessels without traumatizing them, while conversely, the same quality made them unsuitable for holding suture secondary to lack of grip. We also tried different vascular occlusion methods: vessel-loops vs. bulldog-clamps. We noted that bulldog-clamps afforded better occlusion and time efficient application/removal, which would be crucial during vascular anastomoses. Finally, we tested various suture materials: Prolene 6-0 (Ethicon Inc., OH) and GoreTex 50 (Gore Medical Inc., AZ). GoreTex is widely utilized in cardiovascular surgery and we found it to be better suited for robotic vascular anastomoses given its high tensile strength. During the second cadaveric dissection we streamlined our technique (for IDEAL stage 1, our first-in-man operation). Stage 0 therefore permitted us to establish the feasibility of the technique and pelvic cooling. It also allowed us to work out the majority of the nuances of a new procedure (such as patient positioning, instruments, sutures, etc.) in a preclinical setting, thereby, minimizing the harmful effects of learning-curve in patients. In stages 1 (the first 7 patients) and 2a (next 47 patients), the procedure underwent further technical refinements which improved the efficiency (Fig. 1). For example, case-1 onwards, taking cue from open KT, we adopted the use of an ice-gauze jacket which held the ice-slush around the graft kidney and helped maintain local graft hypothermia. Additionally, it allowed atraumatic handling of the graft intracorporeally. The ice-gauze jacket, along with pelvic ice-slush delivered via the GelPOINT, allowed effective graft hypothermia (mean temperature 20.3 C) [1]. This hypothermia presumably translated into improved graft function as the mean discharge creatinine was 1.3 mg/dl in our patients while it was 2 mg/dl in the patients reported by Oberholzer and Giulianotti et al., in whom intracorporeal cooling was not utilized [2,9]. From case-6 onwards, we started extraperitonealizing the graft kidney using the peritoneal flaps raised over the psoas (before this we were simply fixing the graft to the lateral pelvic wall with weck-clips). This insured against graft torsion as Modi et al. [10] demonstrated in their study of laparoscopic KT. Modi et al. [10] noted torsion and loss of graft in 2 out of 6 (33.3%) cases where the graft was left intraperitoneal without fixation, while in the remaining cases, where fixation was performed, there was no torsion. We did not note graft torsion in any patient. Further, intraperitoneal position of the graft has been associated with difficulties in graft biopsy as Oberholzer et al. [9] observed in their study; the patients required open/laparoscopic graft visualization for biopsy. In contrast, in our study, all eleven (20.3%) patients who required graft biopsy could be biopsied percutaneously utilizing routine ultrasound guidance. During this case (case-6) we also improvised our technique of ureteroneocystostomy. Specifically, we started utilizing the barbed V-LOC CV23 suture (Covidien Inc., MA) for detrusor tunnel closure. This decreased the ureterovesical ureteroneocystostomy from 26-min to 15-min without compromising the anastomosis quality. Lastly, during stage 2a of procedure development, not surprisingly, only a few minor modifications occurred. The effects of all alterations are summarized in Fig. 1.
160
A. Sood et al. / International Journal of Surgery 25 (2016) 158e161
Fig. 1. Technical evolution of robotic kidney transplantation (RKT) with regional hypothermia through different stages of the IDEAL model [Y-axis lists the steps in RKT and the Xaxis represents progression of cases through the phases of IDEAL; the technical and/or functional effects of various modifications are listed systematically alongside the corresponding modification].
3. Conclusions The evolution of a surgical technique is a continuous process; however, the vast majority of changes occur early in the life-cycle of a procedure. Further, developing a procedure in a structured manner, starting with preclinical testing is “ideal” as this allows for majority of the technical nuances to be worked out prior to patient surgery, thereby, minimizing patient harm. Lastly, the importance of record keeping should not be ignored as it is only by meticulous record keeping that we can estimate the effect of various
alterations, however small, in a prospective manner, and ensure that other surgeons can benefit from our experience. We encourage other surgical innovators to adopt the IDEAL recommendations to generate high quality research evidence.
Ethical approval Medanta Hospital Institutional Review Board approved the study.
A. Sood et al. / International Journal of Surgery 25 (2016) 158e161
Funding None.
[3]
Author contribution [4]
Writing: AS, PM, PD, RA, WJ, MB, MM. Data collection: AS. Data analysis: AS. Supervision: PM, MB, MM. Logistic Support: RA, MB, MM.
[5]
[6]
Conflicts of interest [7]
None. Guarantor
[8]
Akshay Sood. References [1] M. Menon, R. Abaza, A. Sood, R. Ahlawat, K.R. Ghani, W. Jeong, et al., Robotic kidney transplantation with regional hypothermia: evolution of a novel procedure utilizing the IDEAL guidelines (IDEAL phase 0 and 1), Eur. Urol. 65 (2014) 1001e1009. [2] M. Menon, A. Sood, M. Bhandari, V. Kher, P. Ghosh, R. Abaza, et al., Robotic
[9]
[10]
161
kidney transplantation with regional hypothermia: a step-by-step description of the Vattikuti urology Institute-Medanta technique (IDEAL phase 2a), Eur. Urol. 65 (2014) 991e1000. A. Sood, K.R. Ghani, R. Ahlawat, P. Modi, R. Abaza, W. Jeong, et al., Application of the statistical process control method for prospective patient safety monitoring during the learning phase: robotic kidney transplantation with regional hypothermia (IDEAL phase 2a-b), Eur. Urol. 66 (2014) 371e378. Q.D. Trinh, J. Sammon, M. Sun, P. Ravi, K.R. Ghani, M. Bianchi, et al., Perioperative outcomes of robot-assisted radical prostatectomy compared with open radical prostatectomy: results from the nationwide inpatient sample, Eur. Urol. 61 (2012) 679e685. P. McCulloch, D.G. Altman, W.B. Campbell, D.R. Flum, P. Glasziou, J.C. Marshall, et al., No surgical innovation without evaluation: the IDEAL recommendations, Lancet 374 (2009) 1105e1112. U. Boggi, F. Vistoli, S. Signori, S. D'Imporzano, G. Amorese, G. Consani, et al., Robotic renal transplantation: first European case, Transpl. Int. Off. J. Eur. Soc. Organ Transplant. 24 (2011) 213e218. P. Giulianotti, V. Gorodner, F. Sbrana, I. Tzvetanov, H. Jeon, F. Bianco, et al., Robotic transabdominal kidney transplantation in a morbidly obese patient, Am. J. Transplant. Off. J. Am. Soc. Transplant. Am. Soc. Transpl. Surg. 10 (2010) 1478e1482. W. Jeong, A. Sood, K.R. Ghani, D. Pucheril, J.D. Sammon, N.S. Gupta, et al., Bimanual examination of the retrieved specimen and regional hypothermia during robot-assisted radical prostatectomy: a novel technique for reducing positive surgical margin and achieving pelvic cooling, BJU Int. 114 (2014) 955e957. J. Oberholzer, P. Giulianotti, K.K. Danielson, M. Spaggiari, L. Bejarano-Pineda, F. Bianco, et al., Minimally invasive robotic kidney transplantation for obese patients previously denied access to transplantation, Am. J. Transplant. Off. J. Am. Soc. Transplant. Am. Soc. Transpl. Surg. 13 (2013) 721e728. P. Modi, B. Pal, J. Modi, S. Singla, C. Patel, R. Patel, et al., Retroperitoneoscopic living-donor nephrectomy and laparoscopic kidney transplantation: experience of initial 72 cases, Transplantation 95 (2013) 100e105.