Hypospadias is one of the most common congenital anomalies in penile development. Hypospadias repair is most frequently complicated by bleeding, so adequate haemostasis is a challenging process. Tourniquet use, epinephrine and cauterization are the main methods of haemostasis during hypospadias repair. The aim of this study is to test the safety and efficacy of inducing penile ischemia for haemostasis during hypospadias repair on surgical outcomes. Surgeons and patients-reported outcomes were also evaluated.

This is a double-blinded randomized controlled trial. 110 patients aged from 6 to 36 months with distal penile hypospadias eligible for tubularized incised plate (TIP) repair, were randomly allocated into ischemia (tourniquet) group and non-ischemia (non-tourniquet) group. Patients who were suffering from coagulopathy, sickle cell disease or trait, circumcised patients, those with history of previous failed surgery or severe chordee (>30 degrees after degloving) were excluded. All surgical operations were carried out under general anesthesia plus caudal epidural block, and performed by experts and clinical fellows with >5-year and <5-year experience in TIP repair, respectively. Ischemia was induced by using vessel loop tourniquet. Intra-operative blood loss, frequency of using bipolar diathermy and operative time were estimated. Surgeons' satisfaction of haemostasis for taking adequate sutures was assessed by a 4-tiered questionnaire. During follow up; postoperative complications, success and readmission rates were analyzed. The patients-reported outcome was evaluated by hypospadias objective scoring evaluation (HOSE) questionnaire.

Demographics of the patients and hypospadias characteristics were comparable between the study groups (table 1). Frequency of using bipolar diathermy was more in non-ischemia group (6.7 ± 1.9) than ischemia group (5.7 ± 1.8) (p = 0.007). Operative time was longer in non-ischemia group (60.8 ± 12.5 min) than ischemia group (54.7 ± 14.9 min) (p = 0.028). Clinical fellows' satisfaction was also higher in tourniquet group 38 (97.4%) versus 31 (79.5%) in non-tourniquet group (p = 0.02). There were no significant differences regarding intra-operative blood loss, postoperative complications, success rate, readmission rate and patients-reported outcome between the 2 groups (table 1 and 2).

The frequency of using bipolar diathermy was significantly lower in tourniquet group than non-tourniquet group and the operative time was also significantly shorter in the former group. Therefore, the tourniquet group achieved better haemostasis in a shorter time. Clinical fellows' satisfaction was significantly higher in ischemia group than non-ischemia group, as adequate haemostasis provided a bloodless field sufficient for taking sutures. Moreover, there were no significant differences regarding postoperative complications, success rate, readmission rate and patients-reported outcome between both groups.

Vessel loop tourniquet is effective in minimizing the use of bipolar diathermy and shortening the operative time without significant harmful effects on postoperative surgical or patient-reported outcomes. It also improves clinical fellows' satisfaction of haemostasis for taking adequate sutures.