Elnashar Ahmed M, Albishbishy Mohammed, Sheir Hesham, Elayyouti Moustafa, Elsherbiny Mohamed, Elzohiri Mohamed, Ghazaly Waly M El, Elsaied Adham
Mansoura University Children Hospital, Pediatric Surgery Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Mansoura University Children Hospital, Pediatric Surgery Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
J Pediatr Surg. 2025 Jan;60(1):161994. doi: 10.1016/j.jpedsurg.2024.161994. Epub 2024 Oct 11.
BACKGROUND/PURPOSE: The most frequent complication following hypospadias correction is fistula formation. Recently, fibrin glue has been employed as a 2nd layer covering the urethroplasty resulting in a reduction in the incidence of fistulas. Platelet-rich fibrin (PRF) is an autologous growth factor-rich source. Although the authors recommend the use of additional layers in hypospadias correction, there remains a controversy. In a trial to address this issue, our research was conducted to compare the accessibility of urethroplasty coverage using PRF to traditional local flaps, aiming to prevent fistula formation in hypospadias repair.
This is a prospective single-blinded randomized controlled study that involved 60 hypospadias cases admitted to Mansoura University Children Hospital's Pediatric Surgery department between March 2021 and March 2023. These 60 cases were randomly divided into 2 equal groups: (group A platelet-rich fibrin coverage membrane & group B local dartos flap as an additional layer). Both groups were compared regarding the rate of complications. All cases were evaluated regarding age at repair, type of hypospadias, urethral plate width, length of urethroplasty, and size of the 2nd layer. The blood loss and operative time were documented and post-operatively; the cases were assessed for the repair intactness, shape, and size of the neo-meatus, existence of any post-operative problems such as urethral fistula, urethral stricture, meatal stenosis, failure of the repair, or diverticulum. Statistical analysis was carried out following data collection.
The median length of the 2nd layer in group A was 20 mm (range 15-23 mm) and in group B was 22.5 mm (range 19.5-25 mm) and the difference between the two groups was statistically significant (p = 0.012∗), while its median width in group A was 10 mm (range 10-11 mm) and in group B was 15 mm (range 10-18 mm) and also there was statistically significant difference (p = 0.001∗). The mean operative time in group A was 95.73 ± 11.9 min and in group B was 102.33 ± 10.32 min and there was a statistically significant difference (P < 0.001). The length of hospital stay in group A was 5.47 ± 1.11 days and in group B was 5.47 ± 0.89 days. The urethral fistula was detected in 4 cases of group A (13.3%) and 3 cases of group B (10%). The failure of repair was similar, one case of each group (3.3%). The meatal stenosis was reported in only one case of group A (3.4%) and 7 cases of group B (24.1%) (P = 0.02∗) and the difference was statistically significant. There were no reports of urethral strictures among the cases in either group over the follow-up period (mean 9 months, range 5-17 months).
PRF patch may be employed as a coverage layer over the urethroplasty in repair of the distal hypospadias, especially in cases without accessible vascular flap with comparable outcome to traditional local flaps.
A prospective single blinded randomized controlled trial (computer-generated numbers method).
Level 2.
背景/目的：尿道下裂修复术后最常见的并发症是瘘管形成。最近，纤维蛋白胶已被用作覆盖尿道成形术的第二层材料，从而降低了瘘管的发生率。富血小板纤维蛋白（PRF）是一种富含自体生长因子的来源。尽管作者建议在尿道下裂修复中使用额外的覆盖层，但仍存在争议。为了解决这个问题，我们进行了一项研究，比较使用PRF覆盖尿道成形术与传统局部皮瓣的可及性，旨在预防尿道下裂修复中的瘘管形成。
这是一项前瞻性单盲随机对照研究，纳入了2021年3月至2023年3月期间在曼苏拉大学儿童医院小儿外科收治的60例尿道下裂患者。这60例患者被随机分为两组，每组30例：（A组为富血小板纤维蛋白覆盖膜组，B组为局部肉膜瓣作为额外覆盖层组）。比较两组的并发症发生率。评估所有病例的修复年龄、尿道下裂类型、尿道板宽度、尿道成形术长度和第二层的大小。记录术中失血和手术时间，术后评估修复的完整性、新尿道口的形状和大小，以及是否存在任何术后问题，如尿道瘘、尿道狭窄、尿道口狭窄、修复失败或憩室。数据收集后进行统计分析。
A组第二层的中位长度为20mm（范围15 - 23mm），B组为22.5mm（范围19.5 - 25mm），两组之间的差异具有统计学意义（p = 0.012∗）；A组第二层的中位宽度为10mm（范围10 - 11mm），B组为15mm（范围10 - 18mm），差异也具有统计学意义（p = 0.001∗）。A组的平均手术时间为95.73 ± 11.9分钟，B组为102.33 ± 10.32分钟，差异具有统计学意义（P < 0.001）。A组的住院时间为5.47 ± 1.11天，B组为5.47 ± 0.89天。A组有4例（13.3%）检测到尿道瘘，B组有3例（10%）。修复失败情况相似，每组各1例（3.3%）。仅A组有1例（3.4%）报告尿道口狭窄，B组有7例（24.1%）（P = 0.02∗），差异具有统计学意义。在随访期间（平均9个月，范围5 - 17个月），两组病例均未报告尿道狭窄。
PRF贴片可作为远端尿道下裂修复中尿道成形术的覆盖层，特别是在没有可及血管皮瓣的情况下，其效果与传统局部皮瓣相当。
前瞻性单盲随机对照试验（计算机生成数字法）。
2级。
