Does intraoperative penile tourniquet application during hypospadias repair affect the patients and surgeons reported outcomes? A randomized controlled trial

Abstract

Hemostasis aimed to maintain the bloodless surgical field for better exposure for the surgeon. There are no trials regarding the impact of hemostasis techniques for hypospadias surgery on surgeon satisfaction and patients' reported outcomes. Application of penile tourniquet is a common practice in hypospadias surgery that aims at reducing blood loss and improving visualization. Yet, scarce data exist on the effect of penile tourniquet on hypospadias repair outcomes. To evaluate the safety and efficacy of restraining penile perfusion using a tourniquet in hypospadias repair on the surgical outcome, also surgeons and patients reported outcomes. To evaluate the effect of penile tourniquet application on hypospadias repair outcome and surgeon's satisfaction with intraoperative hemostasis. In this single-blinded randomized controlled trial, a total of 110 children with distal hypospadias amenable for TIP repair were assigned to hypospadias repair with or without intraoperative application of a penile tourniquet. Surgeries were performed by a junior (2-5 years of experience in TIP repair) or a senior pediatric urologist (with >5 years of experience). Intraoperative blood loss, the number of times bipolar diathermy was used, hemoglobin deficit, and operative time were compared. Surgeon's satisfaction with intraoperative hemostasis was evaluated using a 4-tiered questionnaire. Patients were followed up for a minimum of one year. Complications and readmission rates were compared. The patient-reported outcome of hypospadias repair was assessed using the hypospadias objective scoring evaluation (HOSE). Baseline patient demographics and hypospadias characteristics were comparable between the study groups. Bipolar diathermy was more often used in the non-tourniquet group (mean±SD=5.7±1.8 times vs. 6.7±1.9 for the tourniquet group; p=0.007). Also, the operative time was longer in non-tourniquet group [mean=54.7±14.9 vs. 60.8±12.5min (p=0.028)]. Junior surgeons were more likely to be satisfied with hemostasis when a tourniquet was used (97.4% vs. 79.5%, p=0.02). Postoperative complications, readmission rates, and patient-reported outcomes were similar between both groups. The application of penile tourniquet during hypospadias repair can reduce operative time and the need for diathermy use; and also improves junior surgeon's satisfaction with intraoperative hemostasis without adversely affecting success rates or patient-reported outcomes.