PURPOSE: A prospective randomised trial to study the efficacy and safety of hydrocele sclerotherapy with phenol and polidocanol. METHODS:Eighty-six patients with unilateral primary vaginal hydroceles were randomised into three groups: group 1 (phenol sclerotherapy) - 29 patients, group 2 (polidocanol sclerotherapy) - 29 patients and group 3 (operative treatment) - 28 patients. Sclerotherapy was performed on outpatient basis using either 5-10 ml of 5% phenol or 2-4 ml of 1% polidocanol, while patients in group 3 underwent surgical repair of hydrocele (Jaboulay's procedure). Statistical analysis was performed using ANOVA. RESULTS: The cure rates in group 1, 2 and 3 were 96.5%, 51.7% and 100%, respectively. The pain scores (visual analogue scale) in group 1, 2 and 3 at 1 week and 1 month were 14.5 and 1.8; 10.1 and 1.3; 64.0 and 10.6, respectively. There was significant difference among the three groups in mean hospital stay (1.8, 1.5 and 9.7 hours, respectively) and time to work resumption (1.3, 1.1 and 12.7 days, respectively). Statistically significant differences in pain scores and complications were observed between sclerotherapy and operative groups. CONCLUSION: Five percent phenol is a better sclerosant than 1% polidocanol and is as efficacious as operative treatment, with lesser morbidity and similar safety profile.
RCT Entities:
PURPOSE: A prospective randomised trial to study the efficacy and safety of hydrocele sclerotherapy with phenol and polidocanol. METHODS: Eighty-six patients with unilateral primary vaginal hydroceles were randomised into three groups: group 1 (phenol sclerotherapy) - 29 patients, group 2 (polidocanol sclerotherapy) - 29 patients and group 3 (operative treatment) - 28 patients. Sclerotherapy was performed on outpatient basis using either 5-10 ml of 5% phenol or 2-4 ml of 1% polidocanol, while patients in group 3 underwent surgical repair of hydrocele (Jaboulay's procedure). Statistical analysis was performed using ANOVA. RESULTS: The cure rates in group 1, 2 and 3 were 96.5%, 51.7% and 100%, respectively. The pain scores (visual analogue scale) in group 1, 2 and 3 at 1 week and 1 month were 14.5 and 1.8; 10.1 and 1.3; 64.0 and 10.6, respectively. There was significant difference among the three groups in mean hospital stay (1.8, 1.5 and 9.7 hours, respectively) and time to work resumption (1.3, 1.1 and 12.7 days, respectively). Statistically significant differences in pain scores and complications were observed between sclerotherapy and operative groups. CONCLUSION: Five percent phenol is a better sclerosant than 1% polidocanol and is as efficacious as operative treatment, with lesser morbidity and similar safety profile.