|Year : 2023 | Volume
| Issue : 1 | Page : 9-13
To Compare Short-term Surgical Outcome among Patients given Continuous Postoperative Antibiotic Prophylaxis and those given no Postoperative Antibiotics after Urethroplasty for Hypospadias: A Pilot Study
Vivek Manchanda, Mamta Sengar, Parveen Kumar
Department of Pediatric Surgery, Chacha Nehru Bal Chikitsalaya, New Delhi, India
|Date of Submission||09-Jul-2022|
|Date of Decision||13-Sep-2022|
|Date of Acceptance||08-Oct-2022|
|Date of Web Publication||10-Jan-2023|
Department of Pediatric Surgery, Chacha Nehru Bal Chikitsalaya, Raja Ram Kohli Marg, Geeta Colony, New Delhi - 110 031
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: There is no well-accepted guideline or uniform practice for the usage of prophylactic antibiotics along with urethroplasty for hypospadias. As antibiotic resistance is growing, it is imperative to rationalize the usage of antibiotics when a patient is operated for hypospadias.
Aims and Objectives: The study is aimed at finding if there is any difference in outcome if prophylactic antibiotics are given after urethroplasty for hypospadias.
Study Design: Prospective randomized controlled study.
Material and Methods: Forty patients between 6 months and 12 years of age were included in the pilot study. All patients received a single preoperative antibiotic and surgery as per the discretion of the operating surgeon. The participants were randomly assigned to Group A or B, Group A not receiving any prophylactic antibiotic after surgery, and Group B receiving prophylactic antibiotics till indwelling urethral catheter was in situ as per the present antibiotic policy of the institute. The patients were followed up clinically at catheter removal, 1 week after surgery and 1 month after surgery. Urine was analyzed at the start of surgery and after catheter removal. Data were tabulated and analyzed using nonparametric Fischer's exact test with help of Epi Info™ v5.5.8.
Results: Twenty-four patients were included in Group A and 16 in Group B. The clinical profile is presented in the detailed manuscript. Although pus cells could be demonstrated on urine examination in 82.5% of the study participants, only 10% grew organisms on culture media. No difference could be demonstrated among the two groups statistically. On following up with the patients for 1 month, the groups were comparable with respect to surgical site infections, and surgical complications such as urethrocutaneous fistula/dehiscence and thin stream.
Discussion: There was a wide variability among practicing pediatric urologists in prescribing antibiotic prophylaxis for patients undergoing urethroplasty for hypospadias. In the Urologic Surgery Antimicrobial Prophylaxis Policy by the American Urology Association, no recommendation has been made with respect to urethroplasty. Our results are in concurrence with the available English literature which has not shown any benefit of prophylactic antibiotics after hypospadias repair.
Conclusions: Antibiotics may not have a definite role in the prevention of surgical complications and it may be imperative to avoid unnecessary antibiotics to reduce antibiotic resistance.
Keywords: Antibiotic stewardship, clean surgery, hypospadias repair, prophylactic antibiotic, postoperative complications, surgical site infection
|How to cite this article:|
Manchanda V, Sengar M, Kumar P. To Compare Short-term Surgical Outcome among Patients given Continuous Postoperative Antibiotic Prophylaxis and those given no Postoperative Antibiotics after Urethroplasty for Hypospadias: A Pilot Study. J Indian Assoc Pediatr Surg 2023;28:9-13
|How to cite this URL:|
Manchanda V, Sengar M, Kumar P. To Compare Short-term Surgical Outcome among Patients given Continuous Postoperative Antibiotic Prophylaxis and those given no Postoperative Antibiotics after Urethroplasty for Hypospadias: A Pilot Study. J Indian Assoc Pediatr Surg [serial online] 2023 [cited 2023 Feb 1];28:9-13. Available from: https://www.jiaps.com/text.asp?2023/28/1/9/367395
| Introduction|| |
Hypospadias is a common congenital anomaly with a reported incidence of 3–5 cases per 1000 boys. In a recent questionnaire-based study by Kim et al. on the use of antibiotics by pediatric urologists in managing the condition, a wide variety of responses were obtained. While the majority of British pediatric urologists were using therapeutic doses of antibiotics to prevent surgical site infection (SSI), American and New Zealanders were using prophylactic doses and those from Canada were using no postoperative antibiotic after urethroplasty for hypospadias repair.
In a systematic review and meta-analysis by Chua et al. assessing the use of postoperative antibiotic prophylaxis in stented distal hypospadias repair, no methodologically sound study was found in English literature. No result of the meta-analysis in such a scenario can be accepted as a standard or recommendation for practicing surgeons to follow. We thus planned this study to identify if postoperative antibiotics are required posturethroplasty for patients with hypospadias.
| Materials and Methods|| |
This prospective randomized controlled, open-labeled study was performed in the Department of Paediatric Surgery, Chacha Nehru Bal Chikitsalaya, Delhi. Institute's Ethical Committee (IEC) approval was taken for the complete study (158 patients), and initial results (40 patients) are presented here as a pilot study. All patients undergoing primary urethroplasty for hypospadias with ages 6 months to 12 years in the surgical unit were included in the study. Patients having documented urinary tract infection (UTI) at the start of urethroplasty, and those having another infection requiring antibiotics in the postoperative period were excluded from the study. After confirming the inclusion and exclusion criteria, consent was obtained from the parents/legal guardians of the patient, and assent was obtained from the patients 7 years or more in age. All patients received a single preoperative prophylactic antibiotic (injection ceftriaxone, 50–75 mg/kg [IV]) at induction and urethroplasty for correction of hypospadias was performed. The choice of procedure depended on the surgical anatomy of the malformation and surgeon's choice. Urine sample for routine microscopic examination and culture was obtained during surgery. These patients were divided randomly into two groups using Microsoft Excel® software, Group A (with no postoperative antibiotic prophylaxis) and Group B (with standard postoperative antibiotic prophylaxis as per present hospital antibiotic policy (injection ceftriaxone 50–75 mg/kg IV for 48 h, followed by oral amoxyclav (30–50 mg/kg/d) till indwelling catheter is in situ). All patients received standard postoperative care. The catheter remained in situ for 5–10 days as per surgeon's preference. Patients were discharged if they are able to pass urine and were afebrile. The patients were followed up clinically at catheter removal, 1-week post discharge, and 1-month postoperative follow-up. Urine samples were taken at surgery and after catheter removal for routine microscopy and culture.
Outcomes measures postsurgical complications, asymptomatic bacteriuria, symptomatic UTI, and SSI were noted. For the purpose of the study, we defined the postsurgical complications as follows. Any communication of urethral lumen and skin proximal to external urethral meatus was defined as urethra cutaneous fistula, whereas complete disruption of neourethra was classified as dehiscence. Inability to calibrate by 5Fr catheter was documented as meatal stenosis. Inability to calibrate neourethra with 5Fr catheter beyond urethral meatus was called neourethral stricture. Asymptomatic bacteriuria was defined as isolation of bacteria on urine microscopy or urine culture growth of >105 CFU/ml without fever or pyuria, and symptomatic UTI was defined as isolation of bacteria on urine microscopy or urine culture growth of >105 CFU/ml with fever or pyuria. Any purulent discharge or redness at suture site with fever was considered to be an SSI for the purpose of the study. Data were stored in a Microsoft Excel® worksheet. The clinical profile is presented as mean and percentages. Postsurgical complications have been compared in the two groups using nonparametric Fischer's exact test using Epi Info™ v 5.5.8. A P < 0.05 is considered statistically significant. The analysis has been done as per the “intention to treat” protocol.
| Results|| |
The study started enrollment of patients in August 2020. First 40 patients included in the study, till January 2022, with adequate follow-up has been presented here. The age at surgery ranged from 18 months to 12 years with median 4.7 years. Birth order ranged from 1 to 3 (median 2). No documented significant antenatal history could be obtained. One patient had low birth weight. No significant medical or surgical history was ascertained. The mean weight at surgery was 19.36 ± 10.75 kg, and the height was 108.09 ± 24.30 cm. The location of the meatus included one glandular, nine subcoronal, 14 distal penile, 11 mid-penile, four proximal penile, and one penoscrotal hypospadias. Stretched penile length was 47.59 ± 15.53 mm. Preoperative meatal stenosis was noted in 12 (42.8%) patients, although no backpressure changes were observed. Thirteen (32.5%) participants were noted to have shallow glans, 19 (47.5%) with moderate glans groove, and 8 (20%) with good glans groove with glans width of 13.84 ± 4.22 mm. The urethral plate was pink and supple in only 20 (50%) patients, whereas it was pale in 7 (17.5%) and atretic/fibrotic in 13 (32.5%) patients. The width of the urethral plate was 2.34 ± 1.31 mm. The distance of meatus from the tip of glans was 13.97 ± 8.29 mm. Seventeen (42.5%) of the patients had chordee, 16 of which were corrected by degloving only. Only one patient with proximal hypospadias had corporal disproportion and required ventral corporotomy and dorsal plication for chordee correction. Thirty-six (90%) patients underwent tubularized incised plate urethroplasty, whereas 2 (5%) each had onlay flap urethroplasty and glansplasty only for correction of hypospadias. Dartos (ventral or dorsal) was used as second layer to cover urethroplasty in 32 (80%) patients, 3 (7.5%) had tunica vaginalis, and 3 (7.5%) had spongiosal cover, whereas 2 (5%) did not have any interposition tissue before skin closure. Infant feeding tube of size 6–10 Fr was used as urethral catheter for 5–10 days on the preference of operating surgeon. Twenty-three (57%) patients underwent circumcision during the procedure, 9 (22.5%) had prepucioplasty done, and in 8 (20%) patients, prepuce was left untouched (hooded) as per surgeon's preference. Twenty-four (60%) patients were included in Group A and did not receive any antibiotic after urethroplasty, and 16 (40%) patients were included in Group B and received antibiotics as per existing antibiotic policy.
The post-operative results are summarized in [Table 1]. Clinical SSI was documented in 3 (7.5%) patients in Group A, whereas none in Group B. However, no statistical significance could be demonstrated Fisher's exact test (P = 0.2) (relative risk 12.5 [95% confidence interval (CI) −0.73–25.73]). The urine sample taken during the surgery did not show any evidence of infection in any of the patients. However, on catheter removal, pus cells could be demonstrated in all but 7 (82.5%) patients. Urine culture revealed mixture of bacteria in 4 (10%) patients. Fischer's exact test showed no statistical significance between two groups (P = 0.29) (relative risk 2 [95% CI, 0.46–8.70]). Urethrocutaneous fistula/dehiscence was noted in 10 (41.7%) patients in Group A, whereas in 6 (37.5%) in Group B. No statistically significant difference was noted among the two groups (P = 0.53) (relative risk 1.11 [95% CI, 0.50–2.45]).
|Table 1: Results from the study postopertive urine culture, surgical site infection, urethrocutaneous fistula, and thin stream|
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In addition, 5 (20.8%) patients among Group A and 3 (18.8%) patients among Group B complained of thin stream. Nonparametric test, however, did not showed any difference between two groups (P = 0.6) (relative risk 1.11 [95% CI, 0.31–4.01]).
| Discussion|| |
According to the best practice policy statement on urologic surgery antimicrobial prophylaxis by the American Urology Association, although no recommendation has been made with respect to urethroplasty, one single dose of antibiotic prophylaxis is suggested for open surgery without entering urinary tract. Healthcare Infection Control Practices Advisory Committee for the Centre for Disease Control also gave a category 1a recommendation against continued prophylactic antibiotics after skin closure for clean and clean-contaminated procedures even in the presence of a drain.
However, in the survey done by Kim et al., there was a wide variability among practicing pediatric urologists in prescribing antibiotic prophylaxis for such patients. In this questionnaire-based study among 126 pediatric urologists to identify the pattern of antibiotic usage during routine urological procedures to prevent SSIs, they studied the response based on the membership of pediatric urologists. They studied the response based on the membership of pediatric urologists. They found that pediatric urologists all overused antibiotics at induction for hypospadias repair (British used therapeutic doses more than North American or New Zealanders), but those from Canada were less likely to use them after surgery as compared to others.
Urethroplasty, being a clean elective surgery, is not advisable in the presence of UTI or any other active infection for obvious reasons. The same was documented in our study.
Asymptomatic bacteriuria was documented in 20% of the patients included in the study. This is due to colonization of the indwelling catheter Gram-negative bacteria normally located in the groin area. We also documented that there is no demonstrable benefit of antibiotic prophylaxis in the prevention of the colonization of indwelling catheters. Similar results showing no difference in asymptomatic bacteriuria have also been shown in previous studies.,,, In addition, Zeiai et al. showed that the patients receiving continuous antibiotic prophylaxis had increased risk of UTI than patients receiving antibiotics only at induction and at catheter removal. On the other hand, Roth et al. in their randomized controlled trial demonstrated increase in bacteriuria and pyuria in patients not receiving postoperative antibiotics versus those who received antibiotics postoperatively till urethral stent was in place. However, there was no difference in symptomatic UTI or surgical complications among two groups. Symptomatic UTI have also been documented in 6% of boys at least 1 month after urethroplasty.
As only two patients in the study group had dehiscence of the urethroplasty, we included these along with urethrocutaneous fistula for the purpose of statistical analysis. A total of 16 (40%) of the boys undergoing urethroplasty had urethrocutaneous fistula or dehiscence requiring reoperation with no demonstrable difference among the two groups. Similar indifference has also been seen in the literature.,,,
Only three patients in Group A had clinical SSI in form of edema and redness of the penile shaft skin. One patient also had pus discharge noted on the 8th postoperative day. Antibiotic was instituted in all these patients after documentation of clinical infection. No statistical difference was noted among the two groups. Literature also did not mention any improvement in incidence of SSI with the use of antibiotics routinely.,
Twenty percent of the patients, similar in two groups, complained of thin stream and difficulty in micturition. This has been explained in literature to be related to abnormal elasticity of the neourethra.
The current study is aimed at defining the role of prophylactic antibiotics in the management of patients being operated for hypospadias. As the current pilot project includes about 25% of the intended study population no guideline can be derived from the study. However, it can be emphasized that antibiotics may not have a definite role in the prevention of surgical complications and it may be imperative to avoid unnecessary antibiotics to reduce antibiotic resistance.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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