- Email: [email protected]
The Value of Pathological Examination of the Foreskin Following Circumcision
Business of Urology urologypracticejournal.com
The Value of Pathological Examination of the Foreskin Following Circumcision Ilan J. Safir,* Amar P. Patel, Brad P. Moore, Dattatraya Patil, Gabriel Bellott-McGrath, Adeboye O. Osunkoya and Muta M. Issa From the Departments of Urology (IJS, APP, BPM, MMI) and Pathology, Atlanta Veterans Affairs Medical Center (AOO) and Department of Urology, Emory University School of Medicine (IJS, APP, BPM, DP, GB-M, MMI), Atlanta, Georgia
Abstract
Abbreviations and Acronyms
Introduction: We determined the clinical impact and value of routine histopathological examination of the foreskin following circumcision. Methods: We performed a retrospective study of 225 consecutive adult circumcisions. Indications for circumcision were categorized as benign or malignant based on preoperative clinical evaluation. Histopathological results were similarly classified as benign or malignant. Preoperative clinical impression and postoperative histological diagnosis were compared and reported as concordant (in agreement) or discordant (in disagreement). The cost impact of histopathology examination was analyzed with respect to study findings. Results: Of the 225 patients 209 (92.9%) had clinically benign disease on preoperative evaluation and 16 (7.1%) had foreskin lesions suspicious for malignancy. Mean age was 57.0 years (range 23 to 92). Patients were younger in the benign group than in the malignant group (56.5 vs 62.8 years, p ¼ 0.018). Black patients represented 65.8% of the study population and were similarly distributed between the 2 groups (p ¼ 0.405). There was no statistical difference in patient height, weight, body mass index or comorbidities between the 2 groups. Preoperative clinical impression and postoperative histological diagnosis were concordant in all 209 patients in the benign group. Of the 16 patients suspected to have malignant disease preoperatively 9 (56.2%) had malignancy and 7 (43.8%) had benign disease on histopathological examination.
AVAMC = Atlanta Veterans Affairs Medical Center BXO = balanitis xerotica obliterans LSA = lichen sclerosus et atrophicus SCC = squamous cell carcinoma
Conclusions: Routine histological examination of a foreskin specimen in the absence of clinical suspicion for malignancy appears to have diminished benefit in the setting of benign preoperative indications. Omitting this traditional practice in patients with benign surgical indications may positively impact health care costs without compromising quality of care. Key Words: penis; circumcision, male; foreskin; pathology; health care economics and organizations
Submitted for publication September 8, 2014. Study received institutional review board approval at each institution. No direct or indirect financial incentive associated with publishing this article. 2352-0779/15/24-149/0 UROLOGY PRACTICE Ó 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
* Correspondence: Department of Urology, Emory University School of Medicine, EC Building B, Suite 1400, 1365 Clifton Rd, Northeast, Atlanta, Georgia 30322 (telephone: 847-331-3858; FAX: 404-329-2201; e-mail address: isafi[email protected]).
RESEARCH, INC.
http://dx.doi.org/10.1016/j.urpr.2014.11.003 Vol. 2, 149-153, July 2015 Published by Elsevier
150
Value of Pathological Examination of Foreskin
Adult circumcision is a commonly performed urological procedure. In the Veterans Health Administration, the largest health care system in the United States serving more than 7 million veterans, approximately 2,700 adult circumcisions are performed annually.1 With more than 118 million male adults 18 years old or older in the United States an estimated 45,000 adult circumcisions are performed annually.2 The most common indication for adult circumcision is phimosis or paraphimosis, followed by recurrent balanitis and posthitis as well as social, cultural, personal and religious reasons.3 Given these indications, nonmalignant, inflammatory lesions represent the majority of foreskin pathology.4 In contrast, penile cancer is rare and only 1 of 5 cases involve the foreskin.5 Foreskin malignant diagnoses are often clinically suspected and/or apparent before circumcision. The majority of circumcision specimens are benign and yet it remains standard practice to request pathological examination on all foreskin specimens without considering the preoperative clinical impression. The primary objective of our study was to determine the clinical impact of routine histopathological examination of the foreskin after circumcision. Specifically we examined the yield of clinically unsuspected, new histological diagnoses that would impact clinical decisions and management. The secondary objective was to outline the potential cost savings related to omitting unnecessary pathological examination.
included fixation with 10% formaldehyde, paraffin wax tissue blocking, and subsequent hematoxylin and eosin staining on glass slides. Board certified pathologists performed the histopathological examination. To facilitate comparative analysis between the preoperative and postoperative diagnoses the final histopathological results were similarly categorized into benign and malignant diagnoses. Benign pathology results were categorized as normal foreskin, inflammation (acute or chronic) and/or fibrosis. Malignant results included any pathological findings consistent with cancer, including carcinoma in situ. The preoperative and postoperative diagnoses were analyzed and compared. The 2 groups were analyzed using the Student t-test with a 2-tailed distribution and unequal variance. The result of each individual case was allocated to being concordant (similar preoperative clinical and histological diagnoses) or discordant (dissimilar preoperative clinical and histological diagnoses). The cost of histopathological examination of each circumcision specimen was based on the 2014 Medicare reimbursement schedule. Medicare reimbursement for CPT code 88304 (level III surgical pathology gross and microscopic examination) includes a technical component of $31.88 and a professional component of $11.46 for a total of $43.34.7
Results Materials and Methods
The study was approved by the institutional research boards at Emory University and AVAMC. This retrospective study of 225 consecutive adult circumcisions was performed at AVAMC in the 9-year period of 2006 to 2014. All procedures were done with the patient under local penile block anesthesia in an outpatient setting as described previously.6 Demographic, clinical and laboratory information was obtained on all patients, including age, race, height, weight, body mass index, comorbidities, indications for circumcision, physical examination findings and histopathology results. Preoperative indications were categorized into 2 groups based on preoperative history and physical examination. Group 1 included nonmalignant benign indications such as phimosis, paraphimosis, inflammation (balanitis and posthitis), and social, cultural, personal and religious reasons. The presence of concomitant features suspicious for malignancy excluded patients from group 1 and moved them into group 2. Group 2 included lesions suspicious for malignancy based on clinical history and physical examination. All foreskin specimens underwent standard histopathological preparation and examination. Specimen preparation
Analysis included a total of 225 adult circumcisions. Of the 225 patients 209 (92.9%) had clinically benign disease on preoperative evaluation and 16 (7.1%) had lesions suspicious for malignancy. Mean age was 57.0 years (range 23 to 92) and patients were younger in the preoperative benign group than in the preoperative malignant group (56.5 vs 62.8 years, p ¼ 0.018). Benign preoperative indications included phimosis in 161 of 209 patients (77.0%), paraphimosis in 20 (9.6%), inflammation (balanitis and/or posthitis) in 53 (25.4%) and penile discomfort in 18 (8.6%). A third of the patients (68 of 209) requested circumcision for hygienic, social, cultural and/or religious reasons. Black men represented 65.8% of the study population and were similarly distributed between the 2 groups (p ¼ 0.405). There was no statistical difference between the 2 groups in height, weight, body mass index or comorbidities (table 1). All 225 consecutive circumcision specimens underwent routine histopathological examination postoperatively. Of the 209 specimens with benign preoperative indications histopathological results included normal foreskin without documented pathology in 38%, inflammation in 53% and/or fibrosis in 26%. Additionally 5 foreskin specimens
Value of Pathological Examination of Foreskin
151
Table 1. Patient demographic and clinical profile No. pts Mean age (range) No. black (%) Mean kg/m2 body mass index (range) No. comorbidity (%): Hypertension Hyperlipidemia Diabetes mellitus Tobacco use Alcohol dependence Cocaine use Homelessness Renal insufficiency Vascular disease
Overall
Benign
Malignant
p Value
225 57.0 (23e92) 148 (65.8) 31.2 (18.6e57.4)
209 56.5 (23e92) 139 (66.5) 31.3 (19e57)
16 62.8 (45e81) 9 (56.3) 29.8 (19e51)
e 0.018 0.405 0.504
164 140 113 79 40 29 18 22 11
153 131 106 73 36 29 17 20 11
11 9 7 6 4 0 1 2 0
0.699 0.609 0.591 0.835 0.433 0.110 0.789 0.704 0.347
(72.9) (62.2) (50.2) (35.1) (17.8) (12.9) (8.0) (9.8) (4.9)
demonstrated BXO and 2 showed LSA. The preoperative clinical impression and the postoperative histological diagnosis were concordant in all patients in the preoperative benign group (table 2). These results demonstrate that routine histological examination of foreskin in the absence of clinical suspicion of malignancy did not impact subsequent clinical decision making or management. Of the 16 patients suspected to have malignant disease preoperatively malignancy was confirmed on histopathological examination in 9 (56.2%). Malignant pathology demonstrated SCC in situ or Bowen disease in 7, invasive SCC in 1 and metastatic adenocarcinoma of the prostate in 1. The remaining 7 patients (43.8%) had benign disease on histopathological examination. Of these 7 men 1 had BXO. Another patient without malignancy had condyloma acuminata with LSA on histopathological findings. The remainder had chronic inflammation. As such, for patients with clinical suspicion of foreskin malignancy histological examination had an important role in subsequent management decisions.
Discussion
The current health care environment continues to challenge our traditional practices to find ways to lower cost without compromising quality and outcomes. We examined the Table 2. Preoperative clinical impression and postoperative histopathological diagnosis Histopathology
No. procedures (%): Benign Malignant *Malignant. y Benign.
Preop Impression
Concordant
Discordant
225 209 16
218 209 (100) 9 (56.2)
7 0* 7 (43.8)y
(73.2) (62.7) (50.7) (34.9) (17.2) (13.9) (8.1) (9.6) (5.2)
(68.8) (56.2) (43.8) (37.5) (25.0) (6.3) (12.5)
value of routine, nonselective histopathological examination of foreskin specimens following adult circumcision. Results demonstrate that this conventional practice in patients with unsuspected foreskin malignancy may not always be medically indicated. The majority of adult male patients in the Veterans Affairs health care system undergo elective circumcision for benign indications. Therefore, given the low preoperative clinical suspicion for malignancy in this patient population, we estimate that more than 90% of histopathological examinations after circumcision may possibly be omitted without compromising quality of care and patient safety. In a retrospective study of 414 foreskin specimens following circumcision West et al found normal and benign lesions in 131 and 262, respectively.4 Malignant or dysplastic diagnoses were identified in 21 cases. As in our study, the majority of specimens demonstrated benign pathology. Discrepancy between clinical and pathological impression was noted in 77 specimens (18%) compared to our study with 0% discordance between benign preoperative and postoperative diagnoses, and 44% discordance between malignant preoperative and postoperative diagnoses. In a prospective study of 60 men with chronic penile dermatoses who subsequently underwent tissue biopsy Hillman et al identified carcinoma in situ in 6%.8 Our study showed a carcinoma in situ rate of 3% of all specimens. BXO and LSA, which are chronic inflammatory processes of the foreskin and glans, were identified in 9 specimens. Several studies suggest that these lesions may have a cancerous role preoperatively, resulting in a slightly increased rate of SCC.9e11 West et al identified 12% of 334 foreskin specimens as initially having normal, nonspecific diagnoses, which actually demonstrated LSA on pathological re-review by a dermatopathologist.4 We had no further re-review of specimen slides beyond the initial histopathological diagnosis. Given this limitation, LSA may have been
152
Value of Pathological Examination of Foreskin
potentially under diagnosed in our study. It is for this reason that following circumcision we advise all of our patients to seek urological advice if they notice any unusual skin changes or new lesions suspicious for malignancy. Experience in other surgical subspecialties, including otolaryngology, orthopedics and plastic surgery, has shown comparable results and led to similar questioning of the value and cost-to-benefit ratio of routine histopathological examination of certain surgical specimens. In otolaryngology the incidence of unexpected pathological findings on polyp specimens after routine adult nasal polypectomy was less than 1%.12 In orthopedics histopathological examination of routine primary arthroplasty specimens failed to alter patient treatment and/or add value.13 The overall cost related to identifying a single discrepancy was substantial at $4,983.29. Additionally, there was no direct gain in quality adjusted life years. Likewise, routine histopathological examination of intervertebral disc tissue at spinal decompression surgery confirmed benign disc disease in all cases and yielded no additional information that could have altered clinical management.14 Furthermore, since 98.9% of all decompression cases in the United States are considered routine, approximately $29 million could be saved if intervertebral disc tissue specimens were not submitted to pathology. A similar conclusion was reached in regard to routine histopathological examination of mastectomy scars in postmastectomy breast reconstruction.15 While this is traditionally considered an appropriate clinical practice to ensure that no residual cancer exists, none of the clinically unremarkable mastectomy scars were found to contain malignancy. Not sending the scar tissue for histopathological analysis in cases of post-mastectomy breast reconstruction would omit $65 worth of tests. The current practice of routine histopathological examination has persisted in part due to the traditional belief and fear of the rare odd diagnosis and the possibility of medicolegal repercussions. Even when an unsuspected, small, low stage cancerous or chronic inflammatory foreskin lesion such as BXO happens to be overlooked preoperatively, circumcision is often curative without the need for further therapy. With an aging population and a persistent shortage of resources the allocation of health care resources must be purposeful and have meaningful clinical impact. Since the outcome of routine histopathological examination of foreskin provides little if any benefit to postoperative clinical decision making, such traditional practice should be reduced. In our series 92.9% of adult circumcisions at AVAMC had a clinically benign preoperative diagnosis. All 209 preoperatively benign circumcision specimens were confirmed
to be benign on subsequent histological examination and did not impact subsequent clinical decisions or management. As such, omitting histological examination would have resulted in a cost savings of approximately $9,000. With 2,700 adult male circumcisions performed annually in the Veterans Affairs system the estimated annual cost saving would be approximately $105,000. With 40,000 adult male circumcisions performed annually in the United States the cost saving associated with omitting histopathological examination would be approximately $1,600,000 annually. Given that our results demonstrate a 100% benign concordance rate, we suggest that for patients with benign preoperative indications foreskin specimens should not be considered for submission for histopathological examination. Additionally, we suggest that for patients with malignant preoperative indications it is in the best interest of the patient to submit the foreskin for pathological examination since 56% of specimens would prove to be malignant. Based on the results of our study we estimate that fewer than 10% of all foreskin specimens may require definitive histopathological examination. This might result in cost savings without compromising quality of care.
Conclusions
The traditional practice of routine, nonselective histopathological examination of foreskin specimens following routine adult circumcision appears to have a diminished benefit in the setting of benign preoperative indications. Omitting this traditional practice in patients with benign indications may positively impact health care costs without compromising quality of care. However, further studies are warranted. References 1. VHA Support Service Center (VSSC). Available at http://vssc. med.va.gov/VSSCAgreements/Default.aspx?locn¼http%3a%2f% 2fvssc.med.va.gov%2f. Accessed October 27, 2014. 2. U.S. Census Bureau, Population Division: Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States, States, Counties, and Puerto Rico Commonwealth and Municipios: April 1, 2010 to July 1, 2013. Available at http:// factfinder2.census.gov/faces/tableservices/jsf/pages/productview. xhtml?src¼bkmk. Accessed October 27, 2014. 3. Holman JR and Stuessi KA: Adult circumcision. Am Fam Physician 1999; 59: 1514. 4. West DS, Papalas JA, Selim MA et al: Dermatopathology of the foreskin: an institutional experience of over 400 cases. J Cutan Pathol 2013; 40: 11. 5. Burgers JK, Badalament RA and Drago JR: Penile cancer. Clinical presentation, diagnosis, and staging. Urol Clin North Am 1992; 19: 247.
Value of Pathological Examination of Foreskin
6. Wardenburg MJ, Dobbs RW, Barnes G et al: Elective versus routine postoperative clinic appointments after circumcisions performed under local anesthesia. Urology 2013; 81: 1135. 7. Centers for Medicare and Medicaid Services: Physician Fee Schedule. Available at http://www.cms.gov/apps/physicianfee-schedule/search/search-results.aspx?Y¼0&T¼0&HT¼0&CT ¼0&H1¼88304&M¼5. Accessed October 27, 2014. 8. Hillman RJ, Walker MM, Harris JR et al: Penile dermatoses: a clinical and histopathological study. Genitourin Med 1992; 68: 166. 9. Pride HB, Miller OF and Tyler WB: Penile squamous cell carcinoma arising from balanitis xerotica obliterans. J Am Acad Dermatol 1993; 29: 469. 10. Giannakopoulos X, Basioukas K, Dimou S et al: Squamous cell carcinoma of the penis arising from balanitis xerotica obliterans. Int Urol Nephrol 1996; 28: 223.
153
11. Goolamali SI and Pakianathan M: Penile carcinoma arising in balanitis xerotica obliterans. Int J STD AIDS 2006; 17: 135. 12. Garavello W and Gaini RM: Histopathology of routine nasal polypectomy specimens: a review of 2,147 cases. Laryngoscope 2005; 115: 1866. 13. Lin MM, Goldsmith JD, Resch SC et al: Histologic examinations of arthroplasty specimens are not cost-effective. Clin Orthop Relat Res 2012; 470: 1452. 14. Reddy P, Williams R, Willis B et al: Pathological evaluation of intervertebral disc tissue specimens after routine cervical and lumbar decompression. Surg Neurol 2001; 56: 252. 15. Momeni A, Tran P, Dunlap J et al: Is routine histological examination of mastectomy scars justified? An analysis of 619 scars. J Plast Reconstr Aesthet Surg 2013; 66: 182.
The Value of Pathological Examination of the Foreskin Following Circumcision Ilan J. Safir,* Amar P. Patel, Brad P. Moore, Dattatraya Patil, Gabriel Bellott-McGrath, Adeboye O. Osunkoya and Muta M. Issa From the Departments of Urology (IJS, APP, BPM, MMI) and Pathology, Atlanta Veterans Affairs Medical Center (AOO) and Department of Urology, Emory University School of Medicine (IJS, APP, BPM, DP, GB-M, MMI), Atlanta, Georgia
Abstract
Abbreviations and Acronyms
Introduction: We determined the clinical impact and value of routine histopathological examination of the foreskin following circumcision. Methods: We performed a retrospective study of 225 consecutive adult circumcisions. Indications for circumcision were categorized as benign or malignant based on preoperative clinical evaluation. Histopathological results were similarly classified as benign or malignant. Preoperative clinical impression and postoperative histological diagnosis were compared and reported as concordant (in agreement) or discordant (in disagreement). The cost impact of histopathology examination was analyzed with respect to study findings. Results: Of the 225 patients 209 (92.9%) had clinically benign disease on preoperative evaluation and 16 (7.1%) had foreskin lesions suspicious for malignancy. Mean age was 57.0 years (range 23 to 92). Patients were younger in the benign group than in the malignant group (56.5 vs 62.8 years, p ¼ 0.018). Black patients represented 65.8% of the study population and were similarly distributed between the 2 groups (p ¼ 0.405). There was no statistical difference in patient height, weight, body mass index or comorbidities between the 2 groups. Preoperative clinical impression and postoperative histological diagnosis were concordant in all 209 patients in the benign group. Of the 16 patients suspected to have malignant disease preoperatively 9 (56.2%) had malignancy and 7 (43.8%) had benign disease on histopathological examination.
AVAMC = Atlanta Veterans Affairs Medical Center BXO = balanitis xerotica obliterans LSA = lichen sclerosus et atrophicus SCC = squamous cell carcinoma
Conclusions: Routine histological examination of a foreskin specimen in the absence of clinical suspicion for malignancy appears to have diminished benefit in the setting of benign preoperative indications. Omitting this traditional practice in patients with benign surgical indications may positively impact health care costs without compromising quality of care. Key Words: penis; circumcision, male; foreskin; pathology; health care economics and organizations
Submitted for publication September 8, 2014. Study received institutional review board approval at each institution. No direct or indirect financial incentive associated with publishing this article. 2352-0779/15/24-149/0 UROLOGY PRACTICE Ó 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
* Correspondence: Department of Urology, Emory University School of Medicine, EC Building B, Suite 1400, 1365 Clifton Rd, Northeast, Atlanta, Georgia 30322 (telephone: 847-331-3858; FAX: 404-329-2201; e-mail address: isafi[email protected]).
RESEARCH, INC.
http://dx.doi.org/10.1016/j.urpr.2014.11.003 Vol. 2, 149-153, July 2015 Published by Elsevier
150
Value of Pathological Examination of Foreskin
Adult circumcision is a commonly performed urological procedure. In the Veterans Health Administration, the largest health care system in the United States serving more than 7 million veterans, approximately 2,700 adult circumcisions are performed annually.1 With more than 118 million male adults 18 years old or older in the United States an estimated 45,000 adult circumcisions are performed annually.2 The most common indication for adult circumcision is phimosis or paraphimosis, followed by recurrent balanitis and posthitis as well as social, cultural, personal and religious reasons.3 Given these indications, nonmalignant, inflammatory lesions represent the majority of foreskin pathology.4 In contrast, penile cancer is rare and only 1 of 5 cases involve the foreskin.5 Foreskin malignant diagnoses are often clinically suspected and/or apparent before circumcision. The majority of circumcision specimens are benign and yet it remains standard practice to request pathological examination on all foreskin specimens without considering the preoperative clinical impression. The primary objective of our study was to determine the clinical impact of routine histopathological examination of the foreskin after circumcision. Specifically we examined the yield of clinically unsuspected, new histological diagnoses that would impact clinical decisions and management. The secondary objective was to outline the potential cost savings related to omitting unnecessary pathological examination.
included fixation with 10% formaldehyde, paraffin wax tissue blocking, and subsequent hematoxylin and eosin staining on glass slides. Board certified pathologists performed the histopathological examination. To facilitate comparative analysis between the preoperative and postoperative diagnoses the final histopathological results were similarly categorized into benign and malignant diagnoses. Benign pathology results were categorized as normal foreskin, inflammation (acute or chronic) and/or fibrosis. Malignant results included any pathological findings consistent with cancer, including carcinoma in situ. The preoperative and postoperative diagnoses were analyzed and compared. The 2 groups were analyzed using the Student t-test with a 2-tailed distribution and unequal variance. The result of each individual case was allocated to being concordant (similar preoperative clinical and histological diagnoses) or discordant (dissimilar preoperative clinical and histological diagnoses). The cost of histopathological examination of each circumcision specimen was based on the 2014 Medicare reimbursement schedule. Medicare reimbursement for CPT code 88304 (level III surgical pathology gross and microscopic examination) includes a technical component of $31.88 and a professional component of $11.46 for a total of $43.34.7
Results Materials and Methods
The study was approved by the institutional research boards at Emory University and AVAMC. This retrospective study of 225 consecutive adult circumcisions was performed at AVAMC in the 9-year period of 2006 to 2014. All procedures were done with the patient under local penile block anesthesia in an outpatient setting as described previously.6 Demographic, clinical and laboratory information was obtained on all patients, including age, race, height, weight, body mass index, comorbidities, indications for circumcision, physical examination findings and histopathology results. Preoperative indications were categorized into 2 groups based on preoperative history and physical examination. Group 1 included nonmalignant benign indications such as phimosis, paraphimosis, inflammation (balanitis and posthitis), and social, cultural, personal and religious reasons. The presence of concomitant features suspicious for malignancy excluded patients from group 1 and moved them into group 2. Group 2 included lesions suspicious for malignancy based on clinical history and physical examination. All foreskin specimens underwent standard histopathological preparation and examination. Specimen preparation
Analysis included a total of 225 adult circumcisions. Of the 225 patients 209 (92.9%) had clinically benign disease on preoperative evaluation and 16 (7.1%) had lesions suspicious for malignancy. Mean age was 57.0 years (range 23 to 92) and patients were younger in the preoperative benign group than in the preoperative malignant group (56.5 vs 62.8 years, p ¼ 0.018). Benign preoperative indications included phimosis in 161 of 209 patients (77.0%), paraphimosis in 20 (9.6%), inflammation (balanitis and/or posthitis) in 53 (25.4%) and penile discomfort in 18 (8.6%). A third of the patients (68 of 209) requested circumcision for hygienic, social, cultural and/or religious reasons. Black men represented 65.8% of the study population and were similarly distributed between the 2 groups (p ¼ 0.405). There was no statistical difference between the 2 groups in height, weight, body mass index or comorbidities (table 1). All 225 consecutive circumcision specimens underwent routine histopathological examination postoperatively. Of the 209 specimens with benign preoperative indications histopathological results included normal foreskin without documented pathology in 38%, inflammation in 53% and/or fibrosis in 26%. Additionally 5 foreskin specimens
Value of Pathological Examination of Foreskin
151
Table 1. Patient demographic and clinical profile No. pts Mean age (range) No. black (%) Mean kg/m2 body mass index (range) No. comorbidity (%): Hypertension Hyperlipidemia Diabetes mellitus Tobacco use Alcohol dependence Cocaine use Homelessness Renal insufficiency Vascular disease
Overall
Benign
Malignant
p Value
225 57.0 (23e92) 148 (65.8) 31.2 (18.6e57.4)
209 56.5 (23e92) 139 (66.5) 31.3 (19e57)
16 62.8 (45e81) 9 (56.3) 29.8 (19e51)
e 0.018 0.405 0.504
164 140 113 79 40 29 18 22 11
153 131 106 73 36 29 17 20 11
11 9 7 6 4 0 1 2 0
0.699 0.609 0.591 0.835 0.433 0.110 0.789 0.704 0.347
(72.9) (62.2) (50.2) (35.1) (17.8) (12.9) (8.0) (9.8) (4.9)
demonstrated BXO and 2 showed LSA. The preoperative clinical impression and the postoperative histological diagnosis were concordant in all patients in the preoperative benign group (table 2). These results demonstrate that routine histological examination of foreskin in the absence of clinical suspicion of malignancy did not impact subsequent clinical decision making or management. Of the 16 patients suspected to have malignant disease preoperatively malignancy was confirmed on histopathological examination in 9 (56.2%). Malignant pathology demonstrated SCC in situ or Bowen disease in 7, invasive SCC in 1 and metastatic adenocarcinoma of the prostate in 1. The remaining 7 patients (43.8%) had benign disease on histopathological examination. Of these 7 men 1 had BXO. Another patient without malignancy had condyloma acuminata with LSA on histopathological findings. The remainder had chronic inflammation. As such, for patients with clinical suspicion of foreskin malignancy histological examination had an important role in subsequent management decisions.
Discussion
The current health care environment continues to challenge our traditional practices to find ways to lower cost without compromising quality and outcomes. We examined the Table 2. Preoperative clinical impression and postoperative histopathological diagnosis Histopathology
No. procedures (%): Benign Malignant *Malignant. y Benign.
Preop Impression
Concordant
Discordant
225 209 16
218 209 (100) 9 (56.2)
7 0* 7 (43.8)y
(73.2) (62.7) (50.7) (34.9) (17.2) (13.9) (8.1) (9.6) (5.2)
(68.8) (56.2) (43.8) (37.5) (25.0) (6.3) (12.5)
value of routine, nonselective histopathological examination of foreskin specimens following adult circumcision. Results demonstrate that this conventional practice in patients with unsuspected foreskin malignancy may not always be medically indicated. The majority of adult male patients in the Veterans Affairs health care system undergo elective circumcision for benign indications. Therefore, given the low preoperative clinical suspicion for malignancy in this patient population, we estimate that more than 90% of histopathological examinations after circumcision may possibly be omitted without compromising quality of care and patient safety. In a retrospective study of 414 foreskin specimens following circumcision West et al found normal and benign lesions in 131 and 262, respectively.4 Malignant or dysplastic diagnoses were identified in 21 cases. As in our study, the majority of specimens demonstrated benign pathology. Discrepancy between clinical and pathological impression was noted in 77 specimens (18%) compared to our study with 0% discordance between benign preoperative and postoperative diagnoses, and 44% discordance between malignant preoperative and postoperative diagnoses. In a prospective study of 60 men with chronic penile dermatoses who subsequently underwent tissue biopsy Hillman et al identified carcinoma in situ in 6%.8 Our study showed a carcinoma in situ rate of 3% of all specimens. BXO and LSA, which are chronic inflammatory processes of the foreskin and glans, were identified in 9 specimens. Several studies suggest that these lesions may have a cancerous role preoperatively, resulting in a slightly increased rate of SCC.9e11 West et al identified 12% of 334 foreskin specimens as initially having normal, nonspecific diagnoses, which actually demonstrated LSA on pathological re-review by a dermatopathologist.4 We had no further re-review of specimen slides beyond the initial histopathological diagnosis. Given this limitation, LSA may have been
152
Value of Pathological Examination of Foreskin
potentially under diagnosed in our study. It is for this reason that following circumcision we advise all of our patients to seek urological advice if they notice any unusual skin changes or new lesions suspicious for malignancy. Experience in other surgical subspecialties, including otolaryngology, orthopedics and plastic surgery, has shown comparable results and led to similar questioning of the value and cost-to-benefit ratio of routine histopathological examination of certain surgical specimens. In otolaryngology the incidence of unexpected pathological findings on polyp specimens after routine adult nasal polypectomy was less than 1%.12 In orthopedics histopathological examination of routine primary arthroplasty specimens failed to alter patient treatment and/or add value.13 The overall cost related to identifying a single discrepancy was substantial at $4,983.29. Additionally, there was no direct gain in quality adjusted life years. Likewise, routine histopathological examination of intervertebral disc tissue at spinal decompression surgery confirmed benign disc disease in all cases and yielded no additional information that could have altered clinical management.14 Furthermore, since 98.9% of all decompression cases in the United States are considered routine, approximately $29 million could be saved if intervertebral disc tissue specimens were not submitted to pathology. A similar conclusion was reached in regard to routine histopathological examination of mastectomy scars in postmastectomy breast reconstruction.15 While this is traditionally considered an appropriate clinical practice to ensure that no residual cancer exists, none of the clinically unremarkable mastectomy scars were found to contain malignancy. Not sending the scar tissue for histopathological analysis in cases of post-mastectomy breast reconstruction would omit $65 worth of tests. The current practice of routine histopathological examination has persisted in part due to the traditional belief and fear of the rare odd diagnosis and the possibility of medicolegal repercussions. Even when an unsuspected, small, low stage cancerous or chronic inflammatory foreskin lesion such as BXO happens to be overlooked preoperatively, circumcision is often curative without the need for further therapy. With an aging population and a persistent shortage of resources the allocation of health care resources must be purposeful and have meaningful clinical impact. Since the outcome of routine histopathological examination of foreskin provides little if any benefit to postoperative clinical decision making, such traditional practice should be reduced. In our series 92.9% of adult circumcisions at AVAMC had a clinically benign preoperative diagnosis. All 209 preoperatively benign circumcision specimens were confirmed
to be benign on subsequent histological examination and did not impact subsequent clinical decisions or management. As such, omitting histological examination would have resulted in a cost savings of approximately $9,000. With 2,700 adult male circumcisions performed annually in the Veterans Affairs system the estimated annual cost saving would be approximately $105,000. With 40,000 adult male circumcisions performed annually in the United States the cost saving associated with omitting histopathological examination would be approximately $1,600,000 annually. Given that our results demonstrate a 100% benign concordance rate, we suggest that for patients with benign preoperative indications foreskin specimens should not be considered for submission for histopathological examination. Additionally, we suggest that for patients with malignant preoperative indications it is in the best interest of the patient to submit the foreskin for pathological examination since 56% of specimens would prove to be malignant. Based on the results of our study we estimate that fewer than 10% of all foreskin specimens may require definitive histopathological examination. This might result in cost savings without compromising quality of care.
Conclusions
The traditional practice of routine, nonselective histopathological examination of foreskin specimens following routine adult circumcision appears to have a diminished benefit in the setting of benign preoperative indications. Omitting this traditional practice in patients with benign indications may positively impact health care costs without compromising quality of care. However, further studies are warranted. References 1. VHA Support Service Center (VSSC). Available at http://vssc. med.va.gov/VSSCAgreements/Default.aspx?locn¼http%3a%2f% 2fvssc.med.va.gov%2f. Accessed October 27, 2014. 2. U.S. Census Bureau, Population Division: Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States, States, Counties, and Puerto Rico Commonwealth and Municipios: April 1, 2010 to July 1, 2013. Available at http:// factfinder2.census.gov/faces/tableservices/jsf/pages/productview. xhtml?src¼bkmk. Accessed October 27, 2014. 3. Holman JR and Stuessi KA: Adult circumcision. Am Fam Physician 1999; 59: 1514. 4. West DS, Papalas JA, Selim MA et al: Dermatopathology of the foreskin: an institutional experience of over 400 cases. J Cutan Pathol 2013; 40: 11. 5. Burgers JK, Badalament RA and Drago JR: Penile cancer. Clinical presentation, diagnosis, and staging. Urol Clin North Am 1992; 19: 247.
Value of Pathological Examination of Foreskin
6. Wardenburg MJ, Dobbs RW, Barnes G et al: Elective versus routine postoperative clinic appointments after circumcisions performed under local anesthesia. Urology 2013; 81: 1135. 7. Centers for Medicare and Medicaid Services: Physician Fee Schedule. Available at http://www.cms.gov/apps/physicianfee-schedule/search/search-results.aspx?Y¼0&T¼0&HT¼0&CT ¼0&H1¼88304&M¼5. Accessed October 27, 2014. 8. Hillman RJ, Walker MM, Harris JR et al: Penile dermatoses: a clinical and histopathological study. Genitourin Med 1992; 68: 166. 9. Pride HB, Miller OF and Tyler WB: Penile squamous cell carcinoma arising from balanitis xerotica obliterans. J Am Acad Dermatol 1993; 29: 469. 10. Giannakopoulos X, Basioukas K, Dimou S et al: Squamous cell carcinoma of the penis arising from balanitis xerotica obliterans. Int Urol Nephrol 1996; 28: 223.
153
11. Goolamali SI and Pakianathan M: Penile carcinoma arising in balanitis xerotica obliterans. Int J STD AIDS 2006; 17: 135. 12. Garavello W and Gaini RM: Histopathology of routine nasal polypectomy specimens: a review of 2,147 cases. Laryngoscope 2005; 115: 1866. 13. Lin MM, Goldsmith JD, Resch SC et al: Histologic examinations of arthroplasty specimens are not cost-effective. Clin Orthop Relat Res 2012; 470: 1452. 14. Reddy P, Williams R, Willis B et al: Pathological evaluation of intervertebral disc tissue specimens after routine cervical and lumbar decompression. Surg Neurol 2001; 56: 252. 15. Momeni A, Tran P, Dunlap J et al: Is routine histological examination of mastectomy scars justified? An analysis of 619 scars. J Plast Reconstr Aesthet Surg 2013; 66: 182.