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The third message, perhaps the message that can be most substantively gained from the experience with mesh implantation, is that of the importance of physician education, training, and practice surveillance, which all are aspects of medical professionalism and, specifically, self-regulation [5,6]. As surgeons, we should acknowledge that these aspects of professional care are applicable to any new technology or treatment that we may seek to adopt for any condition. We should also accept the very real eventuality that there have been significant untoward outcomes related to mesh implantation—and not all of these can be solely attributed to the mesh devices. Just because a surgeon can implant, the question of whether that surgeon should implant is a matter of some debate. Perhaps the most important consideration associated with the use of surgical mesh for pelvic floor indications (as with any other new technology) is the appropriateness of surgeon introductory education from the standpoint of initial exposure and safe early utilization but also from the standpoint of chronic surveillance of experience and outcomes. The recent emergence of registries within the specialties of urology and urogynecology (which sadly lags other surgical subspecialties) may be a mechanism to ensure chronic safety of experience with new technologies. Another critical aspect of technological use is experience with and frequency of use of the new technology by the specific surgeon in question. It is unclear how many meshtype procedures should be performed before some level of expertise is obtained. Certainly, a minimal number of procedures should be performed to establish initial competency and to ensure ongoing facility with the intervention. Although the importance of post–medical school graduate education in urology and urogynecology is critical for technologies to be introduced to trainees, the exposure of postgraduate surgeons to new technologies remains problematic and, as of yet, nonstandardized. It is critically important for surgeons and surgical societies to become more active in self-regulation of surgical activity and perhaps to partner with national entities (inclusive of regulatory authorities) for purposes of ensuring adequate
Re: Robotic Intracorporeal Orthotopic Neobladder During Radical Cystectomy in 132 Patients Desai MM, Gill IS, de Castro Abreu AL, et al J Urol 2014;192:1734–40 Experts’ summary: In a retrospective, two-institution study, Desai and coworkers demonstrated the feasibility of totally intracorporeal robot-assisted orthotopic bladder substitution after radical cystectomy (RC) and reported on the perioperative and early functional results. Of 136 scheduled patients over a 10-yr time period, only 4 in the early experience were converted to open surgery. For the remaining 132 patients, with robotically constructed neobladders, mean operative time (OT) and hospital stay were 7.6 h and 10.6 d, respectively. Interestingly, major complications
adoption and ongoing utilization of technologies. If patient safety is our ultimate goal, then these types of controls are critical. Will the introduction and adoption of new technologies be delayed by committing to enhance education, proficiency, and experience monitoring? The experience with meshes points to the need for this type of process, especially with complicated technologies that have associated diverse and highly impactful complications. The ability to recognize incipient safety or outcomes concerns through enhanced self-regulation can only improve the experience with a newly introduced technology. Conflicts of interest: The author has had consultant relationships with Allergan and Medtronic.
References [1] Danford JM, Osborn DJ, Reynolds WS, Biller DH, Dmochowski RR. Postoperative pain outcomes after transvaginal mesh revision. Int Urogynecol J 2015;26:65–9. [2] Crosby EC, Abernethy M, Berger MB, DeLancey JO, Fenner DE, Morgan DM. Symptom resolution after operative management of complications from transvaginal mesh. Obstet Gynecol 2014;123:134–9. [3] Tijdink MM, Vierhout ME, Heesakkers JP, Withagen MI. Surgical management of mesh-related complications after prior pelvic floor reconstructive surgery with mesh. Int Urogynecol J 2011; 22:1395–404. [4] Withagen MI, Vierhout ME, Hendriks JC, Kluivers KB, Milani AL. Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet Gynecol 2011;118:629–36. [5] Chantler C, Ashton R. The purpose and limits to professional selfregulation. JAMA 2009;302:2032–3. [6] Wilkinson TJ, Wade WB, Knock LD. A blueprint to assess professionalism: results of a systematic review. Acad Med 2009;84:551–8. Roger Dmochowski Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA E-mail address: [email protected].
http://dx.doi.org/10.1016/j.eururo.2015.02.018
(Clavien grades 3–4) were observed in 15% of patients within 30 d and in another 13% at 30–90 d postoperatively. At a mean follow-up of 25 mo, urinary continence (no or one daily pad) was available for only 73 patients with a minimum 6-mo follow-up and was achieved by 84%. The rate of ureteroileal anastomotic strictures was 3.8%. Analysis of the learning curve revealed a significant decrease in hospital stay and (in only one institution) in OT and estimated blood loss, but no significant improvement in complication rate over time was noted. Experts’ comments: As emphasized by the authors, this study has to be regarded primarily as a feasibility study of intracorporeal robot-assisted neobladder after RC at two centers of excellence that pioneered minimally invasive surgery. There is little doubt that this procedure is one of the most challenging robotic interventions,
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the dissemination of which outside of dedicated, high-volume centers should be scrutinized. We have the following comments on the study results. First, it is noteworthy that total OT, even in the most contemporary procedures (cases 76–86) remained in the range of 6–8 h. Whether this is due to the low yearly volume of robotic neobladders (average of approximately six per center) or to the true technical complexity of the intervention, with an inherently steep learning curve, remains debatable. Nonetheless, this finding raises questions about the operative efficiency of the robotic neobladder, since the benefits of the minimally invasive approach may be abrogated by a long OT. A longer OT, in fact, has been identified as an independent risk factor for high-grade complications in RC patients [1]. Moreover, a longer OT with robotic versus open RC might explain the substantial equivalence in complication rates observed in available comparative trials [2–4]. In addition, a short OT is a paramount prerequisite for the adoption of a fast-track postoperative protocol for enhanced functional recovery after RC. Second, the recent history of other robotic procedures has demonstrated the limited feasibility of large and robust randomized controlled trials comparing robotic and open approaches. Examining the IDEAL criteria, robotic neobladder after RC is still in the exploration stage [5]. The next step, which is preliminary to a cost-effectiveness analysis, should be comparison with contemporary open neobladder series by experienced surgeons in the context of more feasible matched-pair analyses. Third, the function of both the neobladder and the upper urinary tract and the metabolic consequences remain to be assessed at long-term follow-up to fully ascertain whether the excellent results achieved by open surgery [6] may be replicated using the robot. For the time being, we believe this type of surgery should be offered to well-selected and well-informed patients and be performed at highly experienced robotic centers in which surgeon and nursing teams have standardized knowledge of the numerous steps of this complex intervention.
Conflicts of interest: The authors have nothing to disclose.
References [1] De Nunzio C, Cindolo L, Leonardo C, et al. Analysis of radical cystectomy and urinary diversion complications with the Clavien classification system in an Italian real life cohort. Eur J Surg Oncol 2013; 39:792–8. [2] Nix J, Smith A, Kurpad R, Nielsen ME, Wallen EM, Pruthi RS. Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results. Eur Urol 2010;57:196–201. [3] Parekh DJ, Messer J, Fitzgerald J, Ercole B, Svatek R. Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus robotic assisted radical cystectomy. J Urol 2013;189:474–9. [4] Bochner BH, Dalbagni G, Sjoberg DD, et al. Comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: a randomized clinical trial. Eur Urol 2015;67:1042–50. [5] McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374: 1105–12. [6] Hautmann RE, Volkmer BG, Schumacher MC, Gschwend JE, Studer UE. Long-term results of standard procedures in urology: the ileal neobladder. World J Urol 2006;24:305–14.
Gianluca Giannarinia, Vito Palumbob, Vincenzo Ficarraa,c,* a
Urology Unit, Academic Medical Center Hospital ‘‘Santa Maria della Misericordia’’, Udine, Italy b
Department of Oncologic, Surgical and Gastrointestinal Sciences, Urology Unit, University of Padua, Padua, Italy
c
Department of Experimental and Clinical Medical Sciences, Urology Unit, University of Udine, Udine, Italy *Corresponding author. Department of Experimental and Clinical Medical Sciences, Urology Unit, University of Udine, Academic Medical Center Hospital ‘‘Santa Maria della Misericordia,’’ Piazzale Santa Maria della Misericordia 15, IT-33100 Udine, Italy. E-mail address: vincenzo.fi[email protected] (V. Ficarra).
http://dx.doi.org/10.1016/j.eururo.2015.02.019
EUROPEAN UROLOGY 67 (2015) 1186–1192
The third message, perhaps the message that can be most substantively gained from the experience with mesh implantation, is that of the importance of physician education, training, and practice surveillance, which all are aspects of medical professionalism and, specifically, self-regulation [5,6]. As surgeons, we should acknowledge that these aspects of professional care are applicable to any new technology or treatment that we may seek to adopt for any condition. We should also accept the very real eventuality that there have been significant untoward outcomes related to mesh implantation—and not all of these can be solely attributed to the mesh devices. Just because a surgeon can implant, the question of whether that surgeon should implant is a matter of some debate. Perhaps the most important consideration associated with the use of surgical mesh for pelvic floor indications (as with any other new technology) is the appropriateness of surgeon introductory education from the standpoint of initial exposure and safe early utilization but also from the standpoint of chronic surveillance of experience and outcomes. The recent emergence of registries within the specialties of urology and urogynecology (which sadly lags other surgical subspecialties) may be a mechanism to ensure chronic safety of experience with new technologies. Another critical aspect of technological use is experience with and frequency of use of the new technology by the specific surgeon in question. It is unclear how many meshtype procedures should be performed before some level of expertise is obtained. Certainly, a minimal number of procedures should be performed to establish initial competency and to ensure ongoing facility with the intervention. Although the importance of post–medical school graduate education in urology and urogynecology is critical for technologies to be introduced to trainees, the exposure of postgraduate surgeons to new technologies remains problematic and, as of yet, nonstandardized. It is critically important for surgeons and surgical societies to become more active in self-regulation of surgical activity and perhaps to partner with national entities (inclusive of regulatory authorities) for purposes of ensuring adequate
Re: Robotic Intracorporeal Orthotopic Neobladder During Radical Cystectomy in 132 Patients Desai MM, Gill IS, de Castro Abreu AL, et al J Urol 2014;192:1734–40 Experts’ summary: In a retrospective, two-institution study, Desai and coworkers demonstrated the feasibility of totally intracorporeal robot-assisted orthotopic bladder substitution after radical cystectomy (RC) and reported on the perioperative and early functional results. Of 136 scheduled patients over a 10-yr time period, only 4 in the early experience were converted to open surgery. For the remaining 132 patients, with robotically constructed neobladders, mean operative time (OT) and hospital stay were 7.6 h and 10.6 d, respectively. Interestingly, major complications
adoption and ongoing utilization of technologies. If patient safety is our ultimate goal, then these types of controls are critical. Will the introduction and adoption of new technologies be delayed by committing to enhance education, proficiency, and experience monitoring? The experience with meshes points to the need for this type of process, especially with complicated technologies that have associated diverse and highly impactful complications. The ability to recognize incipient safety or outcomes concerns through enhanced self-regulation can only improve the experience with a newly introduced technology. Conflicts of interest: The author has had consultant relationships with Allergan and Medtronic.
References [1] Danford JM, Osborn DJ, Reynolds WS, Biller DH, Dmochowski RR. Postoperative pain outcomes after transvaginal mesh revision. Int Urogynecol J 2015;26:65–9. [2] Crosby EC, Abernethy M, Berger MB, DeLancey JO, Fenner DE, Morgan DM. Symptom resolution after operative management of complications from transvaginal mesh. Obstet Gynecol 2014;123:134–9. [3] Tijdink MM, Vierhout ME, Heesakkers JP, Withagen MI. Surgical management of mesh-related complications after prior pelvic floor reconstructive surgery with mesh. Int Urogynecol J 2011; 22:1395–404. [4] Withagen MI, Vierhout ME, Hendriks JC, Kluivers KB, Milani AL. Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet Gynecol 2011;118:629–36. [5] Chantler C, Ashton R. The purpose and limits to professional selfregulation. JAMA 2009;302:2032–3. [6] Wilkinson TJ, Wade WB, Knock LD. A blueprint to assess professionalism: results of a systematic review. Acad Med 2009;84:551–8. Roger Dmochowski Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA E-mail address: [email protected].
http://dx.doi.org/10.1016/j.eururo.2015.02.018
(Clavien grades 3–4) were observed in 15% of patients within 30 d and in another 13% at 30–90 d postoperatively. At a mean follow-up of 25 mo, urinary continence (no or one daily pad) was available for only 73 patients with a minimum 6-mo follow-up and was achieved by 84%. The rate of ureteroileal anastomotic strictures was 3.8%. Analysis of the learning curve revealed a significant decrease in hospital stay and (in only one institution) in OT and estimated blood loss, but no significant improvement in complication rate over time was noted. Experts’ comments: As emphasized by the authors, this study has to be regarded primarily as a feasibility study of intracorporeal robot-assisted neobladder after RC at two centers of excellence that pioneered minimally invasive surgery. There is little doubt that this procedure is one of the most challenging robotic interventions,
1192
EUROPEAN UROLOGY 67 (2015) 1186–1192
the dissemination of which outside of dedicated, high-volume centers should be scrutinized. We have the following comments on the study results. First, it is noteworthy that total OT, even in the most contemporary procedures (cases 76–86) remained in the range of 6–8 h. Whether this is due to the low yearly volume of robotic neobladders (average of approximately six per center) or to the true technical complexity of the intervention, with an inherently steep learning curve, remains debatable. Nonetheless, this finding raises questions about the operative efficiency of the robotic neobladder, since the benefits of the minimally invasive approach may be abrogated by a long OT. A longer OT, in fact, has been identified as an independent risk factor for high-grade complications in RC patients [1]. Moreover, a longer OT with robotic versus open RC might explain the substantial equivalence in complication rates observed in available comparative trials [2–4]. In addition, a short OT is a paramount prerequisite for the adoption of a fast-track postoperative protocol for enhanced functional recovery after RC. Second, the recent history of other robotic procedures has demonstrated the limited feasibility of large and robust randomized controlled trials comparing robotic and open approaches. Examining the IDEAL criteria, robotic neobladder after RC is still in the exploration stage [5]. The next step, which is preliminary to a cost-effectiveness analysis, should be comparison with contemporary open neobladder series by experienced surgeons in the context of more feasible matched-pair analyses. Third, the function of both the neobladder and the upper urinary tract and the metabolic consequences remain to be assessed at long-term follow-up to fully ascertain whether the excellent results achieved by open surgery [6] may be replicated using the robot. For the time being, we believe this type of surgery should be offered to well-selected and well-informed patients and be performed at highly experienced robotic centers in which surgeon and nursing teams have standardized knowledge of the numerous steps of this complex intervention.
Conflicts of interest: The authors have nothing to disclose.
References [1] De Nunzio C, Cindolo L, Leonardo C, et al. Analysis of radical cystectomy and urinary diversion complications with the Clavien classification system in an Italian real life cohort. Eur J Surg Oncol 2013; 39:792–8. [2] Nix J, Smith A, Kurpad R, Nielsen ME, Wallen EM, Pruthi RS. Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results. Eur Urol 2010;57:196–201. [3] Parekh DJ, Messer J, Fitzgerald J, Ercole B, Svatek R. Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus robotic assisted radical cystectomy. J Urol 2013;189:474–9. [4] Bochner BH, Dalbagni G, Sjoberg DD, et al. Comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: a randomized clinical trial. Eur Urol 2015;67:1042–50. [5] McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374: 1105–12. [6] Hautmann RE, Volkmer BG, Schumacher MC, Gschwend JE, Studer UE. Long-term results of standard procedures in urology: the ileal neobladder. World J Urol 2006;24:305–14.
Gianluca Giannarinia, Vito Palumbob, Vincenzo Ficarraa,c,* a
Urology Unit, Academic Medical Center Hospital ‘‘Santa Maria della Misericordia’’, Udine, Italy b
Department of Oncologic, Surgical and Gastrointestinal Sciences, Urology Unit, University of Padua, Padua, Italy
c
Department of Experimental and Clinical Medical Sciences, Urology Unit, University of Udine, Udine, Italy *Corresponding author. Department of Experimental and Clinical Medical Sciences, Urology Unit, University of Udine, Academic Medical Center Hospital ‘‘Santa Maria della Misericordia,’’ Piazzale Santa Maria della Misericordia 15, IT-33100 Udine, Italy. E-mail address: vincenzo.fi[email protected] (V. Ficarra).
http://dx.doi.org/10.1016/j.eururo.2015.02.019
