Efficacy and safety of two disposable circumcision suture devices for circumcision in adults: A prospective comparative multicenter study.

Abstract

INTRODUCTION AND OBJECTIVE: Disposable circumcision suture devices have been developed to optimize outcomes of circumcision, one of the most common surgical procedures worldwide. The aim of this study is to evaluate the efficacy and safety of two different disposable circumcision suture devices (DCSDs) and compare their surgical outcomes.

METHODS: A prospective comparative multicenter study was performed between November 2019 and October 2021. Patients with congenital or acquired phimosis were included. Patients underwent circumcision using a DCSD (CircCurerTM or the ZSR® device) according to the surgeon preference and device availability. Postoperative follow-up was scheduled at 1 week and 2 months for all patients.

RESULTS: A total of 215 patients were enrolled, 120 underwent circumcision using CircCurerTM (Group A) and 95 patients using ZSR® (Group B). No differences were observed in baseline characteristics between the two groups (p>0.05). Mean (SD) operative time was 7.0 (2.5) minutes with no significant difference between the groups (p=0.678). Seven patients (5.8%) in Group A and 2 (2.1%) in Group B required accessory stitches (p=0.156). Four subjects (3.3%) in Group A and 1 (1.1%) in group B presented hematoma (p=0.266). Surgical site infection occurred in 1 (0.8%) in Group A and 2 (2.1%) in Group B (p=0.413). Metal clips fell out spontaneously in 39 patients (32.5%) of Group A and 47 (49.5%) of Group B (p<0.001). Median (IQR) Numeric Rating Scale (NRS) for postoperative pain was 2.5 (0-4) in Group A and 2.0 (0-4) in Group B (p=0.284). At 2 months, patients of both groups reported a median (IQR) satisfaction of 9 (8-9) points (p=0.469).

CONCLUSIONS: DCSDs appear to allow effective and safe circumcision, with short operative times, uncommon and mild complications, and high patient satisfaction; although there are several devices with some relevant differences on the market.