EUROPEAN UROLOGY 69 (2016) 686–690
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Platinum Priority – Reconstructive Urology
Editorial by Fabio Castiglione, Michael S. Floyd Jr., Frank Van der Aa and Steven Joniau on pp. 691–692 of this issue
The Surgical Learning Curve for One-stage Anterior Urethroplasty:
A Prospective Single-surgeon Study
Nicola Fossati a,*, Guido Barbagli a,b, Alessandro Larcher a, Paolo Dell’Oglio a, Salvatore Sansalone c,
Giovanni Lughezzani d, Giorgio Guazzoni e[1_TD$IF], Francesco Montorsi a, Massimo Lazzeri d
a
Division of Oncology/Unit of Urology[2_TD$IF], IRCCS Ospedale San Raffaele, Milan, Italy; b Centro Chirurgico Toscano, Arezzo, Italy; c Department of Experimental
Medicine and Surgery, University of Tor Vergata, Rome, Italy;
d
Department of Urology,[3_TD$IF] Istituto Clinico Humanitas[4_TD$IF] IRCCS, Clinical and Research [5_TD$IF]Hospital,
Rozzano, Milan, Italy; e Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Humanitas University[6_TD$IF], Rozzano, Milan, Italy
Article info
Abstract
Article history:
Accepted September 14, 2015
Background: The learning process for one-stage anterior urethroplasty has never been
addressed before.
Objective: To evaluate the surgical learning curve for one-stage anterior urethroplasty.
Design, setting, and participants: Data from 641 consecutive patients treated with onestage urethroplasty for urethral stricture were collected prospectively. All the procedures were performed by a single surgeon between 1994 and 2014.
Intervention: One-stage anterior urethroplasty using substitute tissues.
Outcome measurements and statistical analysis: The outcome was treatment failure,
defined as any postoperative instrumentation needed including dilation. Surgeon experience was coded as the total number of one-stage urethroplasties performed by the
surgeon before the operation. Multivariable Cox regression analysis was used to
evaluate the association between surgeon experience and treatment failure. Covariates
consisted of age, body mass index, smoking history (no, yes, ex-smoker), diabetes history
(no or yes), previous surgical treatments (no or yes), stricture length, and stricture site
(bulbar, penile, panurethral).
Results and limitations: Overall, 546 patients (85%) were treated with one-stage oral
mucosa urethroplasty; penile skin or skin flap was used in 95 patients (15%). Median
follow-up among patients who did not experience surgical failure was 69 mo (interquartile range: 35–118). The failure-free survival at 5 yr was 77% (95% confidence
interval [CI], 74–81). At multivariable analysis, surgeon experience was significantly
associated with a lower probability of treatment failure (hazard ratio per 20 procedures:
0.98; 95% CI, 0.97–0.99; p = 0.008). The surgical learning curve appeared lengthened,
without reaching a plateau even after 600 procedures.
Conclusions: In this single-surgeon analysis, surgical experience has a significant impact
on the probability of treatment success for one-stage urethroplasty. Better results are
achieved only after a long learning curve that may not be justifiable for late-career and
low-volume surgeons.
Patient summary: The probability of surgical success after one-stage urethroplasty is
importantly influenced by surgeon experience. Better results are achieved only after a
very long learning process.
# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Associate Editor:
Christian Gratzke
Keywords:
Learning curve
Urethral diseases
Urethral stricture/surgery
Urologic surgical procedures
Male
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* Corresponding author. Division of Oncology/Unit of Urology, IRCCS Ospedale San Raffaele,
Vita-Salute San Raffaele University, Via Olgettina, 60, 20131 Milan, Italy. Tel. +39 02 2643 7286;
Fax: +39 02 2643 7298.
E-mail address: [email protected] (N. Fossati).
http://dx.doi.org/10.1016/j.eururo.2015.09.023
0302-2838/# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EUROPEAN UROLOGY 69 (2016) 686–690
1.
Introduction
687
as the total number of one-stage urethroplasties performed by the
surgeon before the patient’s operation.
The management of urethral strictures remains a challenging issue in the urologic practice [1]. Endoscopic procedures
such as optical internal urethrotomy and urethral dilation
continue to play an important role for initial treatment.
However, reconstructive urethral surgery has gained
effectiveness in recent years due to its superior long-term
outcomes [2–4]. Open urethroplasty is also regarded as the
gold-standard treatment of resistant urethral stricture
disease [5].
The learning curve for several urologic [6–9] and
nonurologic surgeries [10–12] was previously reported.
However, the learning process for one-stage urethroplasty
has never been addressed before. This is of utmost
importance because the learning curve has relevant clinical
implications for patient safety and surgical outcomes
during the learning process [13].
With this in mind, we aimed to evaluate the first largest
single-surgeon experience for one-stage anterior urethroplasty. We hypothesized that surgical experience has a
significant impact on the probable success of the procedure.
We evaluated the surgical learning curve for one-stage
anterior urethroplasty in a large cohort of patients treated
by a single surgeon over the last 2 decades.
2.4.
Outcome definition
The outcome of the study was treatment failure, defined as any
postoperative instrumentation needed (including dilation), according to
previous studies [3,18–20].
2.5.
Follow-up
Uroflowmetry and urine culture were repeated every 6 mo in the first
2 yr and annually thereafter. When symptoms of decreased voiding flow
were present and uroflowmetry was <12 ml/s, retrograde and voiding
urethrography, urethral ultrasound, and urethroscopy were repeated to
fully document re-stricture features.
2.6.
Statistical analysis
Our statistical analysis consisted of two steps. First, multivariable Cox
regression analysis was used to evaluate the association between
surgeon experience and treatment failure. Surgeon experience was
entered as a continuous variable, using restricted cubic splines with
knots at the tertiles to allow a nonlinear relationship between
experience and failure. Covariates consisted of age, BMI, smoking
history, diabetes history, history of surgical treatments, stricture length,
and stricture site.
Second, to produce a learning curve, we calculated the probability of
2.
Materials and methods
2.1.
Patient population
freedom from treatment failure at 5 yr after surgery predicted by the
model for each level of surgical experience, using the mean value for
The study cohort consisted of 641 consecutive patients treated with onestage anterior urethroplasty for urethral stricture by a single surgeon
covariates. Such probability was plotted against surgeon experience to
obtain the surgical learning curve for one-stage urethroplasty.
All statistical analyses were performed using Stata software v.12
(StataCorp LP, College Station, TX, USA).
(G.B.) between 1994 and 2014. Data were prospectively collected from
the first case treated by the surgeon during his career. We therefore were
3.
Results
able to analyze data on all the surgeon’s patients throughout his career to
date.
2.2.
Surgical technique
All patients were treated with one-stage anterior urethroplasty using
substitute tissues. Detailed information regarding our surgical technique
for the treatment of both penile and bulbar stenosis was previously
described [14–17]. One-stage penile urethroplasty was performed using
either a free graft (penile skin vs oral mucosa) or a skin flap [14]. Onestage bulbar urethroplasty was performed using a free graft (penile skin
vs oral mucosa) placed in either the ventral or dorsal urethral surface
[15–17].
2.3.
Definition of variables
All patients had complete clinical data that consisted of age at surgery,
body mass index (BMI), smoking history (no, yes. ex-smoker), diabetes
history (no or yes), etiology of stenosis (idiopathic, iatrogenic, infectious/
lichen sclerosus related, or traumatic), and history of surgical treatments
(including urethral dilation, endoscopic urethrotomy, or urethroplasty).
Retrograde and voiding cystourethrography was performed preoperatively to assess stricture length and stricture site. Information regarding
length of stenosis was obtained from the cystourethrography report and
categorized as !3, 4, 5, or "6 cm, despite the continuous nature of the
variable. At the same time, the site of stenosis was considered as penile,
bulbar, or panurethral. For each patient, surgeon experience was coded
Table 1 shows the descriptive characteristics of the patient
population. Overall, 546 patients (85%) were treated with
one-stage oral mucosa urethroplasty; penile skin or skin
flap was used in 95 patients (15%). Overall, 514 (80%) had
bulbar stricture, 101 (16%) had penile stricture, and 26
(4.0%) had panurethral disease. Previous treatments were
administered to 529 patients (83%).
Median follow-up among patients who did not experience
surgical failure was 69 mo (interquartile range: 35–118). The
rate of freedom from failure at 5 yr was 74% (95% confidence
interval [CI], 77–81).
At multivariable Cox regression analysis (Table 2),
surgeon experience was significantly associated with a
lower probability of treatment failure, after adjusting for
case mix (hazard ratio [HR] per 20 procedures, without the
nonlinear terms: 0.98; 95% CI, 0.97–0.99; p = 0.009).
Figure 1 illustrates the surgical learning curve for onestage anterior urethroplasty. The predicted probability of
freedom from treatment failure at 5 yr was plotted against
surgeon experience. We observed a slight and progressive
increase of treatment success, from 70% during the initial
surgeon experience to approximately 85% after a large
number of performed procedures. Interestingly, the relationship between the probability of surgical success and
688
EUROPEAN UROLOGY 69 (2016) 686–690
Table 1 – Descriptive characteristics of 641 consecutive patients affected by urethral stricture and treated with one-stage anterior
urethroplasty by a single surgeon between 1994 and 2014
Variables
Overall population
n = 641
Surgeon experience
0–149
Age, yr
Body mass index
Smoker
No
Yes
Ex-smoker
Diabetes
No
Yes
Etiology of stenosis
Idiopathic
Iatrogenic
Infection/lichen sclerosus
Trauma
Length of stenosis, cm
!2
3
4
5
"6
Site of stenosis
Bulbar
Penile
Panurethral
Previous treatments
None
Dilation
Urethrotomy
Associated treatments
p value
150–299
300–449
450–641
40 (30–52)
26 (24–27)
40 (30–48)
26 (24–28)
40 (30–55)
25 (23–27)
49 (36–64)
26 (24–28)
341 (53)
181 (28)
119 (19)
82 (55)
47 (32)
20 (13)
75 (50)
66 (44)
9 (6)
82 (55)
35 (23)
33 (22)
102 (53)
33 (17)
57 (30)
614 (96)
27 (4.2)
145 (97)
4 (3)
146 (97)
4 (3)
139 (93)
11 (7)
184 (96)
8 (4)
42 (31–56)
26 (24–28)
<0.0001
0.003
<0.0001
0.15
0.009
369
214
17
41
(58)
(33)
(2.7)
(6.3)
88
41
7
13
(59)
(28)
(5)
(9)
85
47
5
13
(57)
(31)
(3)
(9)
97
42
2
9
(65)
(28)
(1)
(6)
99
84
3
6
(52)
(44)
(2)
(3)
56
158
241
126
60
(8.6)
(25)
(37)
(20)
(9.4)
19
47
49
24
10
(13)
(32)
(33)
(16)
(7)
8
29
61
35
17
(5)
(19)
(41)
(23)
(11)
10
24
61
36
19
(7)
(16)
(41)
(24)
(13)
19
58
70
31
14
(10)
(30)
(36)
(16)
(7)
0.005
0.013
514 (80)
101 (16)
26 (4.1)
118 (79)
30 (20)
1 (1)
110 (73)
32 (21)
8 (5)
124 (83)
19 (13)
7 (5)
162 (84)
20 (10)
10 (5)
0.003
112
29
243
257
(17)
(5)
(38)
(40)
33
9
50
57
(22)
(6)
(34)
(38)
33
9
41
67
(22)
(6)
(27)
(45)
26
7
67
50
(17)
(5)
(45)
(33)
20
4
85
83
(10)
(2)
(44)
(43)
Data are shown as median (interquartile range) or frequency (percentage). Patients were divided into subgroups according to surgeon experience.
Table 2 – Multivariable Cox regression analysis predicting
treatment failure
Predictors
HR
95% CI
p value
Age, yr
Body mass index
Diabetes
No
Yes
Smoker
No
Yes/ex-smoker
Length of stenosis, cm
!3
4
"5
Site of stenosis
Bulbar
Others
Previous treatment
No previous treatment
Dilation
Urethrotomy
Associated treatments
Surgeon experience,
per 20 procedures
1.00
1.03
0.99–1.01
0.97–1.09
0.7
0.3
1.00
0.69
Reference
0.28–1.73
–
0.4
1.00
0.81
Reference
0.58–1.13
–
0.2
1.00
0.92
1.38
Reference
0.61–1.37
0.91–2.08
–
0.7
0.13
1.00
0.94
Reference
0.62–1.42
–
0.8
1.00
3.09
1.38
2.25
0.98
Reference
1.44–6.61
0.79–2.40
1.34–3.80
0.97–0.99
–
0.004
0.3
0.002
0.009
CI = confidence interval; HR = hazard ratio.
In 641 consecutive patients affected by urethral stricture and treated with
one-stage anterior urethroplasty by a single surgeon between 1994 and
2014.
surgeon experience was almost linear, as the gain in success
probability was quite constant over this single-surgeon
experience (approximately 5% per 200 procedures). The
learning curve appeared lengthened, without reaching a
plateau, even after 600 procedures.
4.
Discussion
The learning process for one-stage anterior urethroplasty
has never been addressed before. However, a specific
evaluation of the surgical learning curve is needed to ensure
better surgical outcomes and patient safety that must be
preserved during the surgeon’s learning process.
Our hypothesis stated that surgical experience significantly affects the probability of success of one-stage
urethroplasty. Our results confirmed our hypothesis and
showed that surgical experience was a significant predictor
of failure-free survival (HR per 20 procedures: 0.98; 95% CI,
0.97–0.99; p = 0.008). The probability of 5-yr failure-free
survival increased from 70% to 80% after the first 400 cases
and from 80% to approximately 85% from procedure number
400 to procedure number 600. When the shape of the curve
was evaluated, the learning curve appeared lengthened,
without reaching a plateau even after 600 procedures.
The implications of our results are important for the
management of patients who are candidates for one-stage
urethroplasty because all patients treated during the early
EUROPEAN UROLOGY 69 (2016) 686–690
689
5-yr probability of freedom from failure, %
[(Fig._1)TD$IG]
Surgeon experience, no. of prior surgeries
Fig. 1 – The surgical learning curve for one-stage urethroplasty.
Predicted probability for freedom from treatment failure at 5 yr after
surgery is plotted against increasing surgeon experience. Solid line
shows predicted probability; dotted lines show the 95% confidence
interval.
phase of the learning curve have a lower probability of success
than their counterparts treated later. Therefore, clinical,
educational, and research initiatives are required to moderate
such a negative effect. The observed lack of a plateau in the
learning curve, even after 600 procedures, implies that the
learning phase for this specific surgery has virtually no end.
This finding underscores the need for a dedicated urethral
surgeon in the setting of a dedicated high-volume center and
calls for the development of a specific training protocol. The
changes in the technique over the study period as well as the
improvement of surgical outcomes represent a variable that is
difficult to measure and, as a consequence, to illustrate. As an
example, the introduction of fibrin glue in bulbar urethral
reconstruction [20] as well as different patient positioning
may play a role in the improvement of surgical outcomes over
time. However, considering the hypothetical complexity of
each surgical step, the variable ‘‘surgical experience’’ appears
the most informative surrogate for evaluating the impact of
the surgeon on the final outcome.
The current study represents the first report to investigate the learning process for one-stage urethroplasty, and
consequently our results cannot be validly compared with
other reports. In addition to its novelty, our study has other
important strengths. First, because one surgeon treated all
patients at one high-volume center, our estimate is not
affected by bias related to different techniques and/or
different surgical skills. We relied on the most stringent
methodology for the analysis of the learning curve.
Specifically, when the impact of the surgical experience
was assessed, the outcome chosen was extremely relevant,
namely the need for additional treatment.
Second, our study is also strengthened by its long-term
follow-up. Median follow-up among patients who did not
experience surgical failure was 69 mo. The follow-up length
was adequate for the aim of the current study, as we
recently demonstrated that treatment failure for one-stage
anterior urethroplasty is unlikely 5 yr after surgery [3].
Third, the rate of freedom from treatment failure at 5 yr
was 74% (95% CI, 77–81). Our results were in line with
previous studies: Goonesinghe et al evaluated 144 patients
undergoing urethroplasty at 6 wk, 3 mo, 6 mo, 1 yr, and
annually thereafter, using flexible urethroscopy. They
reported a rate of success of 81% over a median followup of 22 mo [21]. Ahyai et al had an overall success rate of
71% at a median follow-up of 27 mo for patients treated
with urethroplasty after radiotherapy [22].
Despite its uniqueness, the current study has some
limitations. First, information about postoperative examinations, such as uroflowmetry, as well as quality-of-life
questionnaires [23], was not available for a significant
proportion of patients. Therefore, the definition of treatment
failure could not take into account those functional data.
Despite the prospective nature of the study, data regarding
uroflowmetry were missing for a significant proportion of
patients, as it became a routinely used examination during
follow-up after 2005 [24]. Furthermore, recovery of erectile
function and the risk of surgical complications represent
potentially evaluable outcomes. However, the need for any
additional treatments after surgery represents a more
relevant end point, as shown in previous studies [3,18–20].
Second, the single-surgeon study design could account
for important strengths. But at the same time, it could
represent a limitation as well. Our results may not be
representative of a large cohort of surgeons’ experience, and
further studies are needed to corroborate our findings.
Finally, only patients treated with one-stage anterior
urethroplasty were included in this study. However, every
single urethroplasty may somehow influence the next onestage procedure. Nevertheless, the learning curve was
evaluated including patients treated with one-stage anterior urethroplasty only, for three reasons: First, the different
techniques and stages of urethroplasty represent a widely
heterogeneous field, whereas a learning curve study should
focus on a highly specific and standardized procedure. As an
example, all the radical prostatectomy learning curve
studies evaluate the experience of different surgeons, and
the main outcome is usually biochemical recurrence–free
survival [6,7]. However, the vast majority of those surgeons
have presumably performed a substantial number of radical
cystectomies during their career. Clearly, the removal of the
prostate during radical cystectomy may somehow improve
the surgeon technique as well. Despite this, no previous
prostatectomy learning curve studies took into account the
surgeon experience related to radical cystectomy because it
would dramatically increase the complexity of the study
and probably, from a statistical point of view, it would do
more harm than good. Similarly, the evaluation of different
techniques and/or stages for urethroplasty could be
confusing and misleading.
Second, one-stage urethroplasty has been the most
commonly used technique, especially in the last decade
[25], whereas two-stage urethroplasty was usually performed in the most complex and challenging cases, such as
the treatment of lichen sclerosus and the treatment of failure
after previous urethral stricture repair [26]. This issue would
translate into an important selection bias.
690
EUROPEAN UROLOGY 69 (2016) 686–690
Third, the outcome of the study was treatment failure,
defined as any postoperative instrumentation needed
(including dilation). Plotting the learning curve, we
considered the risk of failure at 5 yr after surgery because
this was the timing when most of the failures occurred
[3]. On the contrary, a precise timing for treatment failure
after different techniques and/or stages has never been
addressed before. For all the reasons just listed, we decided
to illustrate the learning curve for one-stage anterior
urethroplasty evaluating patients treated with this specific
surgical procedure only.
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[9] Robert G, Cornu J-N, Fourmarier M, et al. Multicenter prospective
5.
Conclusions
In this single-surgeon analysis, surgical experience has a
significant impact on the probability of treatment success
for one-stage anterior urethroplasty, after adjusting for
patient and stricture characteristics. Better results are
achieved only after a long learning curve that may not be
justifiable for late-career and low-volume surgeons. Clinical, educational, and research initiatives are required to
moderate the negative effects of the learning curve on
surgical care.
evaluation of the learning curve of the holmium laser enucleation of
the prostate (HoLEP). BJU Int. In press. http://dx.doi.org/10.1111/
bju.13124
[10] Maeda T, Tan KY, Konishi F, et al. Accelerated learning curve for
colorectal resection, open versus laparoscopic approach, can be
attained with expert supervision. Surg Endosc 2010;24:2850–4.
[11] Zhou J, Shi Y, Qian F, et al. Cumulative summation analysis of
learning curve for robot-assisted gastrectomy in gastric cancer. J
Surg Oncol 2015;111:760–7.
[12] Marı́n-Gómez LM, Tinoco-González J, Álamo-Martı́nez JM, et al.
Impact of the learning curve on the outcome of domino liver
transplantation. Transplant Proc 2014;46:3092–4.
[13] Vickers AJ. What are the implications of the surgical learning curve?
Eur Urol 2014;65:532–3.
Author contributions: Nicola Fossati had full access to all the data in the
[14] Barbagli G, Morgia G, Lazzeri M. Retrospective outcome analysis of
study and takes responsibility for the integrity of the data and the
one-stage penile urethroplasty using a flap or graft in a homoge-
accuracy of the data analysis.
Study concept and design: Fossati, Barbagli.
Acquisition of data: Barbagli, Sansalone.
Analysis and interpretation of data: Fossati, Larcher, Dell’Oglio.
Drafting of the manuscript: Fossati, Barbagli, Larcher, Lughezzani.
Critical revision of the manuscript for important intellectual content:
Guazzoni, Montorsi, Lazzeri.
Statistical analysis: Fossati, Larcher, Dell’Oglio.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: Guazzoni, Montorsi, Lazzeri.
Other (specify): None.
Financial disclosures: Nicola Fossati certifies that all conflicts of interest,
including specific financial interests and relationships and affiliations
neous series of patients. BJU Int 2008;102:853–60.
[15] Barbagli G, Montorsi F, Guazzoni G, et al. Ventral oral mucosal onlay
graft urethroplasty in nontraumatic bulbar urethral strictures:
surgical technique and multivariable analysis of results in
214 patients. Eur Urol 2013;64:440–7.
[16] Barbagli G, Sansalone S, Romano G, Lazzeri M. Ventral onlay oral
mucosal graft bulbar urethroplasty. BJU Int 2011;108:1218–31.
[17] Barbagli G, Sansalone S, Kulkarni SB, Romano G, Lazzeri M. Dorsal
onlay oral mucosal graft bulbar urethroplasty. BJU Int 2012;109:
1728–41.
[18] Morey AF, McAninch JW. When and how to use buccal mucosal
grafts in adult bulbar urethroplasty. Urology 1996;48:194–8.
[19] Lewis JB, Wolgast KA, Ward JA, Morey AF. Outpatient anterior
urethroplasty: outcome analysis and patient selection criteria. J
Urol 2002;168:1024–6.
relevant to the subject matter or materials discussed in the manuscript
[20] Barbagli G, De Stefani S, Sighinolfi MC, Annino F, Micali S, Bianchi G.
(eg, employment/affiliation, grants or funding, consultancies, honoraria,
Bulbar urethroplasty with dorsal onlay buccal mucosal graft and
stock ownership or options, expert testimony, royalties, or patents filed,
received, or pending), are the following: None.
fibrin glue. Eur Urol 2006;50:467–74.
[21] Goonesinghe SK, Hillary CJ, Nicholson TR, Osman NI, Chapple CR.
Flexible cystourethroscopy in the follow-up of posturethroplasty
Funding/Support and role of the sponsor: None.
patients and characterisation of recurrences. Eur Urol 2015;68:523–9.
[22] Ahyai SA, Schmid M, Kuhl M, et al. Outcomes of ventral onlay buccal
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