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The Need for Additional Procedures in Patients Undergoing Proximal Hypospadias Repairs as Reported in the Pediatric Health Information System Database
The Need for Additional Procedures in Patients Undergoing Proximal Hypospadias Repairs as Reported in the Pediatric Health Information System Database Katherine W. Herbst, Fernando A. Ferrer and John H. Makari* From the Connecticut Children’s Medical Center, Hartford, Connecticut Accepted for publication February 11, 2013. * Correspondence: Division of Urology, Connecticut Children’s Medical Center, 282 Washington St., Suite 2E, Hartford, Connecticut 06106 (telephone: 860-545-9520; FAX: 860-545-9036; e-mail: [email protected]).
Purpose: Using administrative data from freestanding pediatric hospitals in the United States, we characterized the frequency and type of additional procedures required in patients undergoing proximal hypospadias repair in a larger cohort than in published case series across multiple surgeons and institutions. Materials and Methods: A search of the Pediatric Health Information System (PHIS) database by CPT code between January 1, 2005 and June 30, 2010 identified patients undergoing 1 or 2-stage repair for proximal hypospadias. Patient records with inconsistent coding or the suggestion of an alternate pathological condition were excluded from study. A forward query to June 30, 2011 identified additional hypospadias related interventions by CPT codes. Results: We identified 1,679 patients from a total of 37 hospitals. Potential followup was 1 to 6.5 years. One-stage repair was performed in 85.7% of patients at a median age of 10 months. In patients undergoing 2-stage repair the median age at initial repair was 10 months and the median interval between stages was 6 months. Of all patients 26.2% required 1 or more additional interventions beyond definitive repair. Of all additional interventions 84.0% were open, 7.2% were endoscopic treatment for stricture, 0.4% were combined endoscopic and open interventions, and 8.4% were endoscopic evaluation. The median interval from definitive repair to the first intervention was 9 months. Conclusions: These data indicate that more than a quarter of patients who underwent proximal hypospadias repair at pediatric hospitals required additional intervention(s) after what was thought to be definitive repair. These data help create a broader context in a contemporary cohort of patients treated with proximal hypospadias repair. Key Words: urethra, hypospadias, reoperation, reconstructive surgical procedures, endoscopy
HYPOSPADIAS was recently estimated to affect 39.7/10,000 live births (0.78/ 100 male births) in the United States with the rate doubling between 1968 and 1993. During this period, the rate of severe hypospadias in the United States increased threefold to fivefold with a rate of 2.7 to 5.5/10,000 live births (0.05 to 0.11/100 male births).1
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More recent study suggests that between 1993 and 2000 the prevalence of hypospadias in Northern England was 0.31/100 male births but the incidence of surgically corrected hypospadias was unchanged.2 Another recent series suggests that while increasingly complete registry data may contribute to apparent increases
0022-5347/13/1904-1550/0 THE JOURNAL OF UROLOGY® © 2013 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2013.02.029 Vol. 190, 1550-1555, October 2013 Printed in U.S.A.
NEED FOR ADDITIONAL PROCEDURES IN PATIENTS UNDERGOING HYPOSPADIAS REPAIRS
in the hypospadias prevalence, the prevalence of surgically corrected hypospadias in Finland was unchanged between 1970 and 1986.3 Aside from single surgeon and institutional case series data, little data exist on the need for additional surgical interventions in patients treated with 1 and 2-stage repair for proximal hypospadias. We characterized the extent of this need in a contemporary cohort of patients using multi-institutional administrative data from freestanding pediatric hospitals in the United States.
MATERIALS AND METHODS Data for this study were obtained from the PHIS, an administrative database containing inpatient, emergency department, ambulatory surgery and observation data from 43 not-for-profit, tertiary care pediatric hospitals in the United States affiliated with Child Health Corporation of America, Shawnee Mission, Kansas.4 Data are deidentified at the time of data submission, and quality and reliability are ensured through a joint effort between Child Health Corporation of America and participating hospitals. Participating hospitals provide discharge and encounter data, including demographics, diagnoses and procedures, for external benchmarking. Of these hospitals 42 also submit resource use data, eg pharmaceutical, imaging and laboratory data, to PHIS. Included in this study were 37 hospitals that reported CPT code data5 for inpatient and ambulatory admissions during the study period. A total of 15 hospitals (41%) are located in the South, 10 (27%) are in the North Central, 9 (24%) are in the West and 3 (8%) are in the Northeast Census Region. This research, which used de-identified data, was not considered human subject research. It was exempt in accordance with the Common Rule (45 CFR 46.102[f]) and the policy of the Connecticut Children’s Medical Center institutional review board.
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constructed a Kaplan-Meier curve censored for followup duration from definitive repair to study termination to identify intervention-free survival, that is the probability of requiring no further operative intervention from the study entry point to the study end date of June 30, 2011 (see figure).
Main Outcome Definitions Patient definitive repair was defined as the last intended surgical intervention identified by CPT code, ie the 1-stage repair code for those undergoing 1-stage repair and the second-stage repair code for those undergoing 2-stage repair. Patients were counted as having undergone additional open surgical intervention for fistula, stricture, diverticulum, meatal stenosis or persistent or recurrent chordee if the record contained CPT code 53020, 53025, 53235, 53450, 53460, 53520, 53600, 53605, 53620, 54300, 54304, 54340, 54344, 54348 or 54352, or any 1-stage, first-stage or second-stage repair code listed. They were considered to have undergone endoscopic intervention for stricture if the record contained CPT code 52275, 52276, 52281 or 52283, cosmetic intervention if the record contained code 54162 or 54163, or endoscopic evaluation if the record contained code 52000 any time after definitive repair to June 30, 2011. This allowed for a potential minimum of 1 year and a maximum of 61/2 years of followup (see Appendix). An additional operative intervention was defined by date rather than by the number of CPT codes. Multiple CPT codes on the same date were counted as 1 additional operative intervention. When unspecified by CPT, the diagnosis for intervention was identified by the ICD-9 diagnostic code.
RESULTS A total of 1,679 children whose records indicate that they underwent surgical repair for proximal
Patients Included in our study were children who underwent 1-stage surgical repair for proximal hypospadias (CPT code 54332 or 54336) or 2-stage surgical repair for proximal hypospadias (CPT code 54308, 54312 or 54316) between January 1, 2005 and June 30, 2010. Our study excluded records in which a 1-stage code was preceded by a hypospadias related procedural code, records in which a second-stage code was not preceded by a first-stage code or records containing ICD-9 diagnosis or procedural codes indicating disorders of gender development or alternative urethral pathology. To provide additional quality control of the data set, we further excluded patient records in which additional ICD-9 procedure codes were identified in the absence of reported CPT codes and in which ICD-9 diagnostic codes did not include hypospadias (752.61) or congenital chordee (752.63) at initial intervention.
Statistics Data analysis was performed using SPSSÒ, version 17.0. Descriptive statistical analysis is identified when used. We
Five-year intervention-free survival after proximal hypospadias repair.
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hypospadias from January 2005 to the end of June 2010 were identified after applying the stated study exclusion criteria. Excluded from analysis were records containing a 1-stage repair preceded by a hypospadias related procedural or complication code (61), a second-stage code not preceded by a firststage code (195), a second-stage code preceded by a 1-stage code (65), ICD-9 diagnosis or procedural codes indicating disorders of gender development or alternative urethral pathology (200), additional ICD-9 procedure codes without reported CPT codes (116) and absent ICD-9 diagnostic codes for hypospadias or congenital chordee at initial intervention (40). Of the patients 1,439 (85.7%) underwent 1-stage repair for proximal hypospadias at a median age of 10 months. In those treated with 2-stage repair the median age at first surgery was also 10 months with a median 6-month interval between the stages. Race was identified as white in 64.1% of patients, black in 16.7%, other in 8.8% and unknown in 10.4%. Urologists performed 97.0% of the procedures. Of the patients 1,698 (90.5%) were treated as outpatients for definitive repair (table 1). Mean SD followup was 41.3 19.6 months. A total of 440 patients (26.2%) required additional operative interventions beyond definitive repair, of whom 314 (71.4%), 96 (21.8%), 23 (5.2%) and 7 (1.6%) underwent 1, 2, 3 and 4 or more additional interventions, respectively. A total of 569 additional operative interventions were performed in these 440 patients, including 478 open surgical interventions (84.0%). The remaining procedures included endoscopic treatment for stricture in 41 cases (7.2%), endoscopic evaluation alone in 48 (8.4%) and endoscopic treatment for stricture concurrent with an open surgical procedure in 2 (0.4%). Cystourethroscopy was performed concurrently with open operative interventions in 42 cases (8.8%) (table 2). The median interval from definitive repair to the first additional operative intervention was 9
Table 1. Cohort characteristics of 1,679 patients treated with single and 2-stage proximal hypospadias repair between January 1, 2005 and June 30, 2010 in PHIS database with stated exclusion criteria No. race (%): White Black Other Unknown No. surgeon type (%): Urologist General surgeon Plastic surgeon Not specified No. surgery type (%): 1-Stage 2-Stage Median mos age at 1st surgery (IQR): 1-Stage 2-Stage Median mos between stages (IQR) No. definitive repair length of stay (%): Outpt 1 Day 2 Days or greater
1,077 280 148 174
(64.1) (16.7) (8.8) (10.4)
1,629 (97.0) 21 (1.3) 2 (less than 1) 27 (1.6) 1,439 240
(85.7) (14.3)
10 10 6
(7-15) (7-14) (6-8)
1,524 (90.8) 149 (8.9) 2 (less than 1)
months but it varied by diagnosis. The median interval from the first to second, second to third and third to fourth additional operative intervention was 9, 6 and 27 months, respectively (table 3).
DISCUSSION It is generally accepted that the incidence of complications of hypospadias surgery and, thus, the need for additional procedures is related to the location of the meatus with a higher complication rate for more proximal repairs.6 Contemporary reports suggest that the incidence of complications after hypospadias repair is 15% to 45%.710 However, wide variability in reporting and the limitations of 1 surgeon or 1 institution case series data constrain our knowledge of the complications of proximal hypospadias repair and their management. Our primary aim was to determine the need
Table 2. Additional interventions by procedure type and diagnosis
Open surgical intervention: Fistula Meatal stenosis Persistent/recurrent chordee Cosmetic repair Diverticulum Stricture 2 Combined Not specified Endoscopic intervention: Stricture Stricture/open diverticulum Endoscopic evaluation Concurrent endoscopic evaluation Total pts with additional interventions
No. 1 (%)
No. 2 (%)
374 (22.3) 163 (9.7) 27 (1.6) 22 (1.3) 18 (1.1) 16 (1.0) 14 (0.8) 30 (1.8) 84 (5.0) 29 (1.7) 28 (1.7) 1 (less than 0.1) 37 (2.2) 30 (1.8)
76 (4.5) 31 (1.8) 3 (0.2) 6 (0.4) 2 (0.1) 4 (0.2) 14 (0.8) 7 (0.4) 9 (0.5) 13 (0.8) 12 (0.7) 1 (less than 0.1) 7 (0.4) 8 (0.5)
18 5
440
96
23
(26.2)
(5.7)
No. 3 (%)
e e e
(1.1) (0.3)
2 (0.1) 5 (0.3) 3 (0.2) 3 (0.2) 5 (0.3) 1 (less than 0.1) e 4 (0.2) 3 (0.2) (1.4)
No. 4 or Greater (%) 6 2
(0.4) (0.1)
7
(0.4)
e 1 (less than 0.1) e e 2 (0.1) 1 (less than 0.1) e e e e 1 (less than 0.1) e
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Table 3. Interval between additional interventions Median Mos to Additional Intervention (IQR) Repair-1st Open surgical intervention: Fistula Meatal stenosis Persistent/recurrent chordee Cosmetic Diverticulum Stricture 2 Combined Not specified Endoscopic intervention: Stricture Stricture/open diverticulum Endoscopic evaluation Total interventions
9 (1-66) 9 (1-51) 7 (1-42) 9 (5-66) 10 (4-47) 16 (6-45) 7 (2-63) 9 (1-30) 8 (3-57) 3 (1-23) 3 (1-21) 23 10 (1-65) 9 (1-66)
1st-2nd 9 8 17 18 17 6 6 7 9 24 24 5 10 9
(1-66) (5-61) (2-34) (14-39) (6-28) (4-20) (1-66) (1-21) (3-14) (1-57) (1-57) (1-41) (1-66)
2nd-3rd
3rd-4th
6 (1-35) 6 (3-18) e e e 3 (2-4) 4 (1-23) 14 (6-35) 11 (4-19) 1 1 e 6 (1-33) 6 (1-35)
24 (7-46) 37 (27-46) e 33 e e 20 (18-21) 7 e e e e 49 27 (7-49)
for additional surgical procedures in children who underwent proximal hypospadias repair at freestanding pediatric hospitals in North America. To answer this question, we queried the PHIS database by CPT code to identify patients treated with 1 or 2-stage repair for proximal hypospadias and determine which of them underwent additional procedures suggestive of hypospadias complications. Between January 1, 2005 and June 30, 2010, we identified 2,356 patients who underwent procedures with the proximal hypospadias CPT codes in 37 of the 43 hospitals participating in the PHIS database. Strict study exclusion criteria were set to isolate as pure a patient population as possible. We excluded patient records that had diagnostic codes suggesting disorders of gender development or alternative urethral pathology for which a CPT code for hypospadias may have been used due to coding limitations, ie bladder neck obstruction, exstrophy/ epispadias or congenital urethral stricture. Because we could not verify intent for 1 or 2-stage repair, we excluded records in which patients underwent a second-stage hypospadias code procedure without an identifiable first-stage procedure as well as records in which patients underwent first-stage or 1-stage hypospadias repair preceded by another hypospadias related code. We applied additional quality checks to ensure CPT completeness by excluding patient records that included ICD-9 procedural codes without CPT codes, and to ensure correct identification of patients with hypospadias by excluding patient records in which ICD-9 diagnostic codes for hypospadias or chordee were missing from the initial procedure. After identifying a final cohort of 1,679 patients (table 1), we identified 440 in whom additional hypospadias related interventions were coded. Interestingly, 1.4% of the patients who underwent proximal hypospadias repair during this contemporary interval
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were treated by nonurologists. Median age at first surgery was 10 months for 1 and 2-stage repairs. Almost 9% of patients were treated as inpatients. Notably, inpatient admissions may be under reported due to less complete CPT coding for inpatient than ambulatory admissions in the PHIS database. Table 2 shows the type, diagnosis and frequency of additional interventions. Table 3 lists the intervals between definitive repair and additional interventions, and between additional interventions. The most commonly treated diagnosis was urethrocutaneous fistula, while purely cosmetic repairs were performed least often overall. To better understand the timing of additional operative interventions, we constructed a KaplanMeier curve to illustrate the probability of intervention-free survival (see figure). Many patients with hypospadias are otherwise healthy. In the absence of a hypospadias related complication or other hospital admission, there is no way to determine whether patients are still followed at the same institution in the PHIS database. Therefore, this curve overestimates interventionfree survival but highlights the fact that the probability of intervention free survival changes less dramatically after the first 2 years following definitive repair. CPT coding for hypospadias allows for more complete discrimination of disease severity than many other urological codes. However, codes for 1-stage repair describe the anatomical position of the meatus, while 2-stage codes describe repair duration. There is substantial opportunity for variability in each code. Most patients in this series were treated with 1-stage repair. However, the anatomical description provided in CPT coding for 1-stage repair may allow for over coding, that is coding for proximal penile hypospadias may include any meatal position proximal to the mid shaft. This could lead to underestimating the need for additional procedures in patients treated with 1-stage repair by artificially inflating the denominator. Clinical intent cannot be captured by an administrative database record review. Coding variations may have misled our interpretation of which procedure was intended by the surgeon to represent definitive repair. This may relate to absent formal coding instruction for most providers. We frequently found that 1-stage rather than first-stage hypospadias codes were followed by second-stage hypospadias codes (see Appendix). One could hypothesize that this reflects a complication of an intended 1-stage procedure, which required urethroplasty for repair (and second-stage hypospadias repair was coded) or a variation in coding practice. Similarly, patients excluded from review because a
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second-stage repair code was not preceded by a firststage repair code may have undergone the first procedure elsewhere or a variation in coding practice may have resulted in the use of a code that we could not interpret definitively as a first-stage code. Furthermore, when 1-stage hypospadias codes were preceded by additional hypospadias related codes, this could hypothetically represent a complication requiring more proximal/complex additional hypospadias repair or a coding variation for the selection of first-stage and second-stage repairs. Another limitation arising from the use of administrative data is the potential inability to exactly describe the specific complication treated. Procedural codes such as “repair of hypospadias complications (ie fistula, stricture, diverticula).” do not accurately describe the diagnosis treated by the surgeon. This is exacerbated by diagnostic codes such as “hypospadias cripple.” When the diagnosis being treated could not be determined by the CPT code, we reviewed ICD-9 diagnostic codes for reference. Still, the diagnosis could not be determined in 84 of 374 patients (22.5%) undergoing a first additional open intervention. The limitations of using administrative data in general and the PHIS database in particular were highlighted by a number groups.1114 Such limitations include the retrospective nature of these studies, the potential for clerical error, absent clinical data, and the potential for sampling error and lack of generalizability. One of the most significant limitations of this study is the potential for unidentified patient migration. Patients treated at one hospital could not be tracked at other participating hospitals or at hospitals outside the PHIS database. Also, followup duration after proximal hypospadias repair is not standard and one could argue that the followup in the current study is insufficient. The inclusion of CPT data recently increased in the PHIS database, which affected the study interval decision. We favored database accuracy over long-term followup. However, assuming a followup from the date of definitive repair to June 30, 2011, the duration of potential followup in our study is 12 to 78 months (median 41.3), comparable to that in many published series.8,9,11,15e17 Patient migration and followup assumptions are likely important contributors to under reporting additional procedures after proximal hypospadias repair in this study, which we therefore believe exceeds 26.2%. Finally, administrative data do not provide insight into the qualifications or training of the individuals who perform these complex procedures. The inclusion of data only from freestanding pediatric hospitals suggests a higher level of training and experience but this could not be confirmed.
While urologists performed 97% of definitive procedures in this patient cohort, we could not determine the percent of fellowship trained or subspecialty certified pediatric urologists in the data set. Anonymous data describing technically demanding, complex procedures should be interpreted with appropriate caution. Despite all of the actual and potential limitations of this study, we believe that these data contribute to an improved understanding of the current clinical practice of surgical treatment for proximal hypospadias at freestanding pediatric hospitals in North America. The data provide a framework for comparing individual and multi-institutional series to a contemporary cohort of patients treated with proximal hypospadias repair.
CONCLUSIONS More than a quarter of patients who underwent proximal hypospadias repair at PHIS hospitals required additional procedure(s). Limitations of administrative data analysis likely led to under reporting the actual additional intervention rate. However, this result is within the range reported in the current literature and it assists in identifying a more exact rate of re-intervention in the general population. These data help create a broader framework that facilitates improved evaluation of individual case series in the context of a modern cohort of patients treated with proximal hypospadias repair.
APPENDIX CPT Codes Used in PHIS Database Query Single Stage Codes 54332: 1-Stage proximal penile or penoscrotal hypospadias repair requiring extensive dissection to correct chordee and urethroplasty by use of skin graft tube and/or island flap 54336: 1-Stage perineal hypospadias repair requiring extensive dissection to correct chordee and urethroplasty by use of skin graft tube and/or island flap First Stage Codes 54300: Plastic operation of penis for straightening of chordee (eg, hypospadias), with or without mobilization of urethra 54304: Plastic operation on penis for correction of chordee or for first stage hypospadias repair with or without transplantation of prepuce and/or skin flaps 54360: Plastic operation on penis to correct angulation Second Stage Codes 54308: Urethroplasty for second stage hypospadias repair (including urinary diversion); less than 3 cm 54312: Urethroplasty for second stage hypospadias repair (including urinary diversion); greater than 3 cm 54316: Urethroplasty for second stage hypospadias repair (including urinary diversion); with free graft obtained from site other than genitalia Open Surgical Treatment of Complications 53020: Meatotomy, cutting of meatus (separate procedure); except infant 53025: Meatotomy, cutting of meatus (separate procedure); infant 53235: Excision of urethral diverticulum (separate procedure); male 53450: Urethromeatoplasty, with mucosal advancement 53460: Urethromeatoplasty, with partial excision of distal urethral segment
NEED FOR ADDITIONAL PROCEDURES IN PATIENTS UNDERGOING HYPOSPADIAS REPAIRS
53520: Closure of urethrostomy or urethrocutaneous fistula, male (separate procedure) 53600: Dilation of urethral stricture by passage of sound or urethral dilator, male; initial 53605: Dilation of urethral stricture by passage of sound or urethral dilator, male; subsequent 53620: Dilation of urethral stricture by passage of filiform and follower, male; initial 54300: Plastic operation of penis for straightening of chordee (eg, hypospadias), with or without mobilization of urethra 54304: Plastic operation on penis for correction of chordee or for first stage hypospadias repair with or without transplantation of prepuce and/or skin flaps 54340: Repair of hypospadias complications (ie, fistula, stricture, diverticula); by closure, incision or excision, simple 54344: Repair of hypospadias complications (ie, fistula, stricture, diverticula); requiring mobilization of skin flaps and urethroplasty with flap or patch graft 54348: Repair of hypospadias complications (ie fistula, stricture, diverticula); requiring extensive dissection and urethroplasty with flap, patch or tubed graft (includes urinary diversion)
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54352: Repair of hypospadias cripple requiring extensive dissection and excision of previously constructed structures including re-release of chordee and reconstruction of urethra and penis by use of local skin as grafts and island flaps and skin brought in as flaps or grafts Additional hypospadias/urethroplasty codes listed above as single stage, first stage and second stage codes Cosmetic Repair 54162: Lysis or excision of post-circumcision adhesions 54163: Repair of incomplete circumcision Endoscopic Treatment of Stricture 52275: Cystourethroscopy, with internal urethrotomy; male 52276: Cystourethroscopy, with direct internal urethrotomy 52281: Cystourethroscopy, with calibration and/or dilation of urethral stricture or stenosis, with or without meatotomy, with or without injection procedure for cystography, male or female 52283: Cystourethroscopy, with steroid injection into stricture Endoscopic Evaluation 52000: Cystourethroscopy
REFERENCES 1. Paulozzi LJ, Erickson JD and Jackson RJ: Hypospadias trends in two US surveillance systems. Pediatrics 1997; 100: 831. 2. Abdullah NA, Pearce MS, Parker L et al: Birth prevalence of cryptorchidism and hypospadias in northern England, 1993-2000. Arch Dis Child 2007; 92: 576. 3. Aho M, Koivisto AM, Tammela TL et al: Is the incidence of hypospadias increasing? Analysis of Finnish hospital discharge data 1970-1994. Environ Health Perspect 2000; 108: 463. 4. Child Health Corporation of America. Available at http://www.chca.com/index_flash.htm. Accessed September 12, 2012.
children: systematic 20-year review. J Urol 2010; 184: 1469.
increasing in the endoscopic management of vesicoureteral reflux. Pediatr Surg Int 2010; 26: 509.
8. Barroso U Jr, Jednak R, Spencer Barthold J et al: Further experience with the double onlay preputial flap for hypospadias repair. J Urol 2000; 164: 998.
13. Kokorowski PJ, Routh JC, Graham DA et al: Variations in timing of surgery among boys who underwent orchidopexy for cryptorchidism. Pediatrics 2010; 126: e576.
9. Chuang JH and Shieh CS: Two-layer versus onelayer closure in transverse island flap repair of posterior hypospadias. J Pediatr Surg 1995; 30: 739.
14. Routh JC, Graham DA, Estrada CR et al: Contemporary use of nephron-sparing surgery for children with malignant renal tumors at freestanding children’s hospitals. Urology 2011; 78: 422.
10. Patel RP, Shukla AR, Austin JC et al: Modified tubularized transverse preputial island flap repair for severe proximal hypospadias. BJU Int 2005; 95: 901.
6. Retik AB and Atala A: Complications of hypospadias repair. Urol Clin North Am 2002; 29: 329.
11. Vemulakonda VM, Cowan CA, Lendvay TS et al: Surgical management of congenital ureteropelvic junction obstruction: a Pediatric Health Information System database study. J Urol 2008; 180: 1689.
7. Castagnetti M and El-Ghoneimi A: Surgical management of primary severe hypospadias in
12. Sorensen MD, Koyle MA, Cowan CA et al: Injection volumes of dextranomer/hyaluronic acid are
5. Current Procedural Terminology 2012. Chicago: American Medical Association 2011.
15. Chen SC, Yang SS, Hsieh CH et al: Tubularized incised plate urethroplasty for proximal hypospadias. BJU Int 2000; 86: 1050. 16. Borer JG, Bauer SB, Peters CA et al: Tubularized incised plate urethroplasty: expanded use in primary and repeat surgery for hypospadias. J Urol 2001; 165: 581. 17. Snodgrass WT and Lorenzo A: Tubularized incised-plate urethroplasty for proximal hypospadias. BJU Int 2002; 89: 90.
Purpose: Using administrative data from freestanding pediatric hospitals in the United States, we characterized the frequency and type of additional procedures required in patients undergoing proximal hypospadias repair in a larger cohort than in published case series across multiple surgeons and institutions. Materials and Methods: A search of the Pediatric Health Information System (PHIS) database by CPT code between January 1, 2005 and June 30, 2010 identified patients undergoing 1 or 2-stage repair for proximal hypospadias. Patient records with inconsistent coding or the suggestion of an alternate pathological condition were excluded from study. A forward query to June 30, 2011 identified additional hypospadias related interventions by CPT codes. Results: We identified 1,679 patients from a total of 37 hospitals. Potential followup was 1 to 6.5 years. One-stage repair was performed in 85.7% of patients at a median age of 10 months. In patients undergoing 2-stage repair the median age at initial repair was 10 months and the median interval between stages was 6 months. Of all patients 26.2% required 1 or more additional interventions beyond definitive repair. Of all additional interventions 84.0% were open, 7.2% were endoscopic treatment for stricture, 0.4% were combined endoscopic and open interventions, and 8.4% were endoscopic evaluation. The median interval from definitive repair to the first intervention was 9 months. Conclusions: These data indicate that more than a quarter of patients who underwent proximal hypospadias repair at pediatric hospitals required additional intervention(s) after what was thought to be definitive repair. These data help create a broader context in a contemporary cohort of patients treated with proximal hypospadias repair. Key Words: urethra, hypospadias, reoperation, reconstructive surgical procedures, endoscopy
HYPOSPADIAS was recently estimated to affect 39.7/10,000 live births (0.78/ 100 male births) in the United States with the rate doubling between 1968 and 1993. During this period, the rate of severe hypospadias in the United States increased threefold to fivefold with a rate of 2.7 to 5.5/10,000 live births (0.05 to 0.11/100 male births).1
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More recent study suggests that between 1993 and 2000 the prevalence of hypospadias in Northern England was 0.31/100 male births but the incidence of surgically corrected hypospadias was unchanged.2 Another recent series suggests that while increasingly complete registry data may contribute to apparent increases
0022-5347/13/1904-1550/0 THE JOURNAL OF UROLOGY® © 2013 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2013.02.029 Vol. 190, 1550-1555, October 2013 Printed in U.S.A.
NEED FOR ADDITIONAL PROCEDURES IN PATIENTS UNDERGOING HYPOSPADIAS REPAIRS
in the hypospadias prevalence, the prevalence of surgically corrected hypospadias in Finland was unchanged between 1970 and 1986.3 Aside from single surgeon and institutional case series data, little data exist on the need for additional surgical interventions in patients treated with 1 and 2-stage repair for proximal hypospadias. We characterized the extent of this need in a contemporary cohort of patients using multi-institutional administrative data from freestanding pediatric hospitals in the United States.
MATERIALS AND METHODS Data for this study were obtained from the PHIS, an administrative database containing inpatient, emergency department, ambulatory surgery and observation data from 43 not-for-profit, tertiary care pediatric hospitals in the United States affiliated with Child Health Corporation of America, Shawnee Mission, Kansas.4 Data are deidentified at the time of data submission, and quality and reliability are ensured through a joint effort between Child Health Corporation of America and participating hospitals. Participating hospitals provide discharge and encounter data, including demographics, diagnoses and procedures, for external benchmarking. Of these hospitals 42 also submit resource use data, eg pharmaceutical, imaging and laboratory data, to PHIS. Included in this study were 37 hospitals that reported CPT code data5 for inpatient and ambulatory admissions during the study period. A total of 15 hospitals (41%) are located in the South, 10 (27%) are in the North Central, 9 (24%) are in the West and 3 (8%) are in the Northeast Census Region. This research, which used de-identified data, was not considered human subject research. It was exempt in accordance with the Common Rule (45 CFR 46.102[f]) and the policy of the Connecticut Children’s Medical Center institutional review board.
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constructed a Kaplan-Meier curve censored for followup duration from definitive repair to study termination to identify intervention-free survival, that is the probability of requiring no further operative intervention from the study entry point to the study end date of June 30, 2011 (see figure).
Main Outcome Definitions Patient definitive repair was defined as the last intended surgical intervention identified by CPT code, ie the 1-stage repair code for those undergoing 1-stage repair and the second-stage repair code for those undergoing 2-stage repair. Patients were counted as having undergone additional open surgical intervention for fistula, stricture, diverticulum, meatal stenosis or persistent or recurrent chordee if the record contained CPT code 53020, 53025, 53235, 53450, 53460, 53520, 53600, 53605, 53620, 54300, 54304, 54340, 54344, 54348 or 54352, or any 1-stage, first-stage or second-stage repair code listed. They were considered to have undergone endoscopic intervention for stricture if the record contained CPT code 52275, 52276, 52281 or 52283, cosmetic intervention if the record contained code 54162 or 54163, or endoscopic evaluation if the record contained code 52000 any time after definitive repair to June 30, 2011. This allowed for a potential minimum of 1 year and a maximum of 61/2 years of followup (see Appendix). An additional operative intervention was defined by date rather than by the number of CPT codes. Multiple CPT codes on the same date were counted as 1 additional operative intervention. When unspecified by CPT, the diagnosis for intervention was identified by the ICD-9 diagnostic code.
RESULTS A total of 1,679 children whose records indicate that they underwent surgical repair for proximal
Patients Included in our study were children who underwent 1-stage surgical repair for proximal hypospadias (CPT code 54332 or 54336) or 2-stage surgical repair for proximal hypospadias (CPT code 54308, 54312 or 54316) between January 1, 2005 and June 30, 2010. Our study excluded records in which a 1-stage code was preceded by a hypospadias related procedural code, records in which a second-stage code was not preceded by a first-stage code or records containing ICD-9 diagnosis or procedural codes indicating disorders of gender development or alternative urethral pathology. To provide additional quality control of the data set, we further excluded patient records in which additional ICD-9 procedure codes were identified in the absence of reported CPT codes and in which ICD-9 diagnostic codes did not include hypospadias (752.61) or congenital chordee (752.63) at initial intervention.
Statistics Data analysis was performed using SPSSÒ, version 17.0. Descriptive statistical analysis is identified when used. We
Five-year intervention-free survival after proximal hypospadias repair.
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hypospadias from January 2005 to the end of June 2010 were identified after applying the stated study exclusion criteria. Excluded from analysis were records containing a 1-stage repair preceded by a hypospadias related procedural or complication code (61), a second-stage code not preceded by a firststage code (195), a second-stage code preceded by a 1-stage code (65), ICD-9 diagnosis or procedural codes indicating disorders of gender development or alternative urethral pathology (200), additional ICD-9 procedure codes without reported CPT codes (116) and absent ICD-9 diagnostic codes for hypospadias or congenital chordee at initial intervention (40). Of the patients 1,439 (85.7%) underwent 1-stage repair for proximal hypospadias at a median age of 10 months. In those treated with 2-stage repair the median age at first surgery was also 10 months with a median 6-month interval between the stages. Race was identified as white in 64.1% of patients, black in 16.7%, other in 8.8% and unknown in 10.4%. Urologists performed 97.0% of the procedures. Of the patients 1,698 (90.5%) were treated as outpatients for definitive repair (table 1). Mean SD followup was 41.3 19.6 months. A total of 440 patients (26.2%) required additional operative interventions beyond definitive repair, of whom 314 (71.4%), 96 (21.8%), 23 (5.2%) and 7 (1.6%) underwent 1, 2, 3 and 4 or more additional interventions, respectively. A total of 569 additional operative interventions were performed in these 440 patients, including 478 open surgical interventions (84.0%). The remaining procedures included endoscopic treatment for stricture in 41 cases (7.2%), endoscopic evaluation alone in 48 (8.4%) and endoscopic treatment for stricture concurrent with an open surgical procedure in 2 (0.4%). Cystourethroscopy was performed concurrently with open operative interventions in 42 cases (8.8%) (table 2). The median interval from definitive repair to the first additional operative intervention was 9
Table 1. Cohort characteristics of 1,679 patients treated with single and 2-stage proximal hypospadias repair between January 1, 2005 and June 30, 2010 in PHIS database with stated exclusion criteria No. race (%): White Black Other Unknown No. surgeon type (%): Urologist General surgeon Plastic surgeon Not specified No. surgery type (%): 1-Stage 2-Stage Median mos age at 1st surgery (IQR): 1-Stage 2-Stage Median mos between stages (IQR) No. definitive repair length of stay (%): Outpt 1 Day 2 Days or greater
1,077 280 148 174
(64.1) (16.7) (8.8) (10.4)
1,629 (97.0) 21 (1.3) 2 (less than 1) 27 (1.6) 1,439 240
(85.7) (14.3)
10 10 6
(7-15) (7-14) (6-8)
1,524 (90.8) 149 (8.9) 2 (less than 1)
months but it varied by diagnosis. The median interval from the first to second, second to third and third to fourth additional operative intervention was 9, 6 and 27 months, respectively (table 3).
DISCUSSION It is generally accepted that the incidence of complications of hypospadias surgery and, thus, the need for additional procedures is related to the location of the meatus with a higher complication rate for more proximal repairs.6 Contemporary reports suggest that the incidence of complications after hypospadias repair is 15% to 45%.710 However, wide variability in reporting and the limitations of 1 surgeon or 1 institution case series data constrain our knowledge of the complications of proximal hypospadias repair and their management. Our primary aim was to determine the need
Table 2. Additional interventions by procedure type and diagnosis
Open surgical intervention: Fistula Meatal stenosis Persistent/recurrent chordee Cosmetic repair Diverticulum Stricture 2 Combined Not specified Endoscopic intervention: Stricture Stricture/open diverticulum Endoscopic evaluation Concurrent endoscopic evaluation Total pts with additional interventions
No. 1 (%)
No. 2 (%)
374 (22.3) 163 (9.7) 27 (1.6) 22 (1.3) 18 (1.1) 16 (1.0) 14 (0.8) 30 (1.8) 84 (5.0) 29 (1.7) 28 (1.7) 1 (less than 0.1) 37 (2.2) 30 (1.8)
76 (4.5) 31 (1.8) 3 (0.2) 6 (0.4) 2 (0.1) 4 (0.2) 14 (0.8) 7 (0.4) 9 (0.5) 13 (0.8) 12 (0.7) 1 (less than 0.1) 7 (0.4) 8 (0.5)
18 5
440
96
23
(26.2)
(5.7)
No. 3 (%)
e e e
(1.1) (0.3)
2 (0.1) 5 (0.3) 3 (0.2) 3 (0.2) 5 (0.3) 1 (less than 0.1) e 4 (0.2) 3 (0.2) (1.4)
No. 4 or Greater (%) 6 2
(0.4) (0.1)
7
(0.4)
e 1 (less than 0.1) e e 2 (0.1) 1 (less than 0.1) e e e e 1 (less than 0.1) e
NEED FOR ADDITIONAL PROCEDURES IN PATIENTS UNDERGOING HYPOSPADIAS REPAIRS
Table 3. Interval between additional interventions Median Mos to Additional Intervention (IQR) Repair-1st Open surgical intervention: Fistula Meatal stenosis Persistent/recurrent chordee Cosmetic Diverticulum Stricture 2 Combined Not specified Endoscopic intervention: Stricture Stricture/open diverticulum Endoscopic evaluation Total interventions
9 (1-66) 9 (1-51) 7 (1-42) 9 (5-66) 10 (4-47) 16 (6-45) 7 (2-63) 9 (1-30) 8 (3-57) 3 (1-23) 3 (1-21) 23 10 (1-65) 9 (1-66)
1st-2nd 9 8 17 18 17 6 6 7 9 24 24 5 10 9
(1-66) (5-61) (2-34) (14-39) (6-28) (4-20) (1-66) (1-21) (3-14) (1-57) (1-57) (1-41) (1-66)
2nd-3rd
3rd-4th
6 (1-35) 6 (3-18) e e e 3 (2-4) 4 (1-23) 14 (6-35) 11 (4-19) 1 1 e 6 (1-33) 6 (1-35)
24 (7-46) 37 (27-46) e 33 e e 20 (18-21) 7 e e e e 49 27 (7-49)
for additional surgical procedures in children who underwent proximal hypospadias repair at freestanding pediatric hospitals in North America. To answer this question, we queried the PHIS database by CPT code to identify patients treated with 1 or 2-stage repair for proximal hypospadias and determine which of them underwent additional procedures suggestive of hypospadias complications. Between January 1, 2005 and June 30, 2010, we identified 2,356 patients who underwent procedures with the proximal hypospadias CPT codes in 37 of the 43 hospitals participating in the PHIS database. Strict study exclusion criteria were set to isolate as pure a patient population as possible. We excluded patient records that had diagnostic codes suggesting disorders of gender development or alternative urethral pathology for which a CPT code for hypospadias may have been used due to coding limitations, ie bladder neck obstruction, exstrophy/ epispadias or congenital urethral stricture. Because we could not verify intent for 1 or 2-stage repair, we excluded records in which patients underwent a second-stage hypospadias code procedure without an identifiable first-stage procedure as well as records in which patients underwent first-stage or 1-stage hypospadias repair preceded by another hypospadias related code. We applied additional quality checks to ensure CPT completeness by excluding patient records that included ICD-9 procedural codes without CPT codes, and to ensure correct identification of patients with hypospadias by excluding patient records in which ICD-9 diagnostic codes for hypospadias or chordee were missing from the initial procedure. After identifying a final cohort of 1,679 patients (table 1), we identified 440 in whom additional hypospadias related interventions were coded. Interestingly, 1.4% of the patients who underwent proximal hypospadias repair during this contemporary interval
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were treated by nonurologists. Median age at first surgery was 10 months for 1 and 2-stage repairs. Almost 9% of patients were treated as inpatients. Notably, inpatient admissions may be under reported due to less complete CPT coding for inpatient than ambulatory admissions in the PHIS database. Table 2 shows the type, diagnosis and frequency of additional interventions. Table 3 lists the intervals between definitive repair and additional interventions, and between additional interventions. The most commonly treated diagnosis was urethrocutaneous fistula, while purely cosmetic repairs were performed least often overall. To better understand the timing of additional operative interventions, we constructed a KaplanMeier curve to illustrate the probability of intervention-free survival (see figure). Many patients with hypospadias are otherwise healthy. In the absence of a hypospadias related complication or other hospital admission, there is no way to determine whether patients are still followed at the same institution in the PHIS database. Therefore, this curve overestimates interventionfree survival but highlights the fact that the probability of intervention free survival changes less dramatically after the first 2 years following definitive repair. CPT coding for hypospadias allows for more complete discrimination of disease severity than many other urological codes. However, codes for 1-stage repair describe the anatomical position of the meatus, while 2-stage codes describe repair duration. There is substantial opportunity for variability in each code. Most patients in this series were treated with 1-stage repair. However, the anatomical description provided in CPT coding for 1-stage repair may allow for over coding, that is coding for proximal penile hypospadias may include any meatal position proximal to the mid shaft. This could lead to underestimating the need for additional procedures in patients treated with 1-stage repair by artificially inflating the denominator. Clinical intent cannot be captured by an administrative database record review. Coding variations may have misled our interpretation of which procedure was intended by the surgeon to represent definitive repair. This may relate to absent formal coding instruction for most providers. We frequently found that 1-stage rather than first-stage hypospadias codes were followed by second-stage hypospadias codes (see Appendix). One could hypothesize that this reflects a complication of an intended 1-stage procedure, which required urethroplasty for repair (and second-stage hypospadias repair was coded) or a variation in coding practice. Similarly, patients excluded from review because a
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second-stage repair code was not preceded by a firststage repair code may have undergone the first procedure elsewhere or a variation in coding practice may have resulted in the use of a code that we could not interpret definitively as a first-stage code. Furthermore, when 1-stage hypospadias codes were preceded by additional hypospadias related codes, this could hypothetically represent a complication requiring more proximal/complex additional hypospadias repair or a coding variation for the selection of first-stage and second-stage repairs. Another limitation arising from the use of administrative data is the potential inability to exactly describe the specific complication treated. Procedural codes such as “repair of hypospadias complications (ie fistula, stricture, diverticula).” do not accurately describe the diagnosis treated by the surgeon. This is exacerbated by diagnostic codes such as “hypospadias cripple.” When the diagnosis being treated could not be determined by the CPT code, we reviewed ICD-9 diagnostic codes for reference. Still, the diagnosis could not be determined in 84 of 374 patients (22.5%) undergoing a first additional open intervention. The limitations of using administrative data in general and the PHIS database in particular were highlighted by a number groups.1114 Such limitations include the retrospective nature of these studies, the potential for clerical error, absent clinical data, and the potential for sampling error and lack of generalizability. One of the most significant limitations of this study is the potential for unidentified patient migration. Patients treated at one hospital could not be tracked at other participating hospitals or at hospitals outside the PHIS database. Also, followup duration after proximal hypospadias repair is not standard and one could argue that the followup in the current study is insufficient. The inclusion of CPT data recently increased in the PHIS database, which affected the study interval decision. We favored database accuracy over long-term followup. However, assuming a followup from the date of definitive repair to June 30, 2011, the duration of potential followup in our study is 12 to 78 months (median 41.3), comparable to that in many published series.8,9,11,15e17 Patient migration and followup assumptions are likely important contributors to under reporting additional procedures after proximal hypospadias repair in this study, which we therefore believe exceeds 26.2%. Finally, administrative data do not provide insight into the qualifications or training of the individuals who perform these complex procedures. The inclusion of data only from freestanding pediatric hospitals suggests a higher level of training and experience but this could not be confirmed.
While urologists performed 97% of definitive procedures in this patient cohort, we could not determine the percent of fellowship trained or subspecialty certified pediatric urologists in the data set. Anonymous data describing technically demanding, complex procedures should be interpreted with appropriate caution. Despite all of the actual and potential limitations of this study, we believe that these data contribute to an improved understanding of the current clinical practice of surgical treatment for proximal hypospadias at freestanding pediatric hospitals in North America. The data provide a framework for comparing individual and multi-institutional series to a contemporary cohort of patients treated with proximal hypospadias repair.
CONCLUSIONS More than a quarter of patients who underwent proximal hypospadias repair at PHIS hospitals required additional procedure(s). Limitations of administrative data analysis likely led to under reporting the actual additional intervention rate. However, this result is within the range reported in the current literature and it assists in identifying a more exact rate of re-intervention in the general population. These data help create a broader framework that facilitates improved evaluation of individual case series in the context of a modern cohort of patients treated with proximal hypospadias repair.
APPENDIX CPT Codes Used in PHIS Database Query Single Stage Codes 54332: 1-Stage proximal penile or penoscrotal hypospadias repair requiring extensive dissection to correct chordee and urethroplasty by use of skin graft tube and/or island flap 54336: 1-Stage perineal hypospadias repair requiring extensive dissection to correct chordee and urethroplasty by use of skin graft tube and/or island flap First Stage Codes 54300: Plastic operation of penis for straightening of chordee (eg, hypospadias), with or without mobilization of urethra 54304: Plastic operation on penis for correction of chordee or for first stage hypospadias repair with or without transplantation of prepuce and/or skin flaps 54360: Plastic operation on penis to correct angulation Second Stage Codes 54308: Urethroplasty for second stage hypospadias repair (including urinary diversion); less than 3 cm 54312: Urethroplasty for second stage hypospadias repair (including urinary diversion); greater than 3 cm 54316: Urethroplasty for second stage hypospadias repair (including urinary diversion); with free graft obtained from site other than genitalia Open Surgical Treatment of Complications 53020: Meatotomy, cutting of meatus (separate procedure); except infant 53025: Meatotomy, cutting of meatus (separate procedure); infant 53235: Excision of urethral diverticulum (separate procedure); male 53450: Urethromeatoplasty, with mucosal advancement 53460: Urethromeatoplasty, with partial excision of distal urethral segment
NEED FOR ADDITIONAL PROCEDURES IN PATIENTS UNDERGOING HYPOSPADIAS REPAIRS
53520: Closure of urethrostomy or urethrocutaneous fistula, male (separate procedure) 53600: Dilation of urethral stricture by passage of sound or urethral dilator, male; initial 53605: Dilation of urethral stricture by passage of sound or urethral dilator, male; subsequent 53620: Dilation of urethral stricture by passage of filiform and follower, male; initial 54300: Plastic operation of penis for straightening of chordee (eg, hypospadias), with or without mobilization of urethra 54304: Plastic operation on penis for correction of chordee or for first stage hypospadias repair with or without transplantation of prepuce and/or skin flaps 54340: Repair of hypospadias complications (ie, fistula, stricture, diverticula); by closure, incision or excision, simple 54344: Repair of hypospadias complications (ie, fistula, stricture, diverticula); requiring mobilization of skin flaps and urethroplasty with flap or patch graft 54348: Repair of hypospadias complications (ie fistula, stricture, diverticula); requiring extensive dissection and urethroplasty with flap, patch or tubed graft (includes urinary diversion)
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54352: Repair of hypospadias cripple requiring extensive dissection and excision of previously constructed structures including re-release of chordee and reconstruction of urethra and penis by use of local skin as grafts and island flaps and skin brought in as flaps or grafts Additional hypospadias/urethroplasty codes listed above as single stage, first stage and second stage codes Cosmetic Repair 54162: Lysis or excision of post-circumcision adhesions 54163: Repair of incomplete circumcision Endoscopic Treatment of Stricture 52275: Cystourethroscopy, with internal urethrotomy; male 52276: Cystourethroscopy, with direct internal urethrotomy 52281: Cystourethroscopy, with calibration and/or dilation of urethral stricture or stenosis, with or without meatotomy, with or without injection procedure for cystography, male or female 52283: Cystourethroscopy, with steroid injection into stricture Endoscopic Evaluation 52000: Cystourethroscopy
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7. Castagnetti M and El-Ghoneimi A: Surgical management of primary severe hypospadias in
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