Device-assisted versus manual circumcision: a prospective, comparative, multicenter study.

Abstract

Background: Circumcision is a common urological procedure performed for various medical, cultural, religious, and aesthetic reasons.

Aim: This study aimed to compare the effectiveness and safety of device-assisted (DeCi) and manual circumcision (MaCi) in adult European patients.

Methods: We conducted a prospective, comparative, non-randomized multicenter study including 200 consecutive adult males undergoing circumcision under local anesthesia. Patients were divided into two groups (MaCi or DeCi) based on patient preferences following proper counseling. Follow-up was scheduled at 1 week and 1 month post-surgery. Surgical and postoperative outcomes were recorded, with patient satisfaction with aesthetic results as the primary outcome, and procedure-related complications as secondary outcomes. Satisfaction was assessed using a 5-point Likert scale, while postoperative complications were classified using the Clavien-Dindo (CD) system.

Outcomes: A total of 200 patients (100 per group) were included. The DeCi group had a significantly shorter mean operative time than the MaCi group (11.20 ± 5.92 vs. 23.20 ± 7.93 minutes, P < .001). Patient satisfaction with aesthetic results was significantly higher in the DeCi group, with 67.4% of patients being "very satisfied" or "satisfied" compared to 36.7% in the MaCi group (P < .001). The DeCi group also reported significantly lower perceived pain during surgery (mean ± SD visual analogue scale [VAS] score: 1.54 ± 1.77 vs. 4.20 ± 2.10 points, P = .025) and at 1 month postoperatively (mean ± SD VAS score: 0.54 ± 1.03 vs. 2.35 ± 2.77, P < .001). Intraoperative and postoperative complication rates were similar between groups, with no significant differences (P > .05). Only 5% of patients in the MaCi group and 4% in the DeCi group experienced a CD Grade ≥ 3 postoperative complication.

Clinical implications: DeCi appears to offer superior aesthetic outcomes and reduced pain compared to MaCi, making it a promising option for circumcision in adult European men.

Strengths & limitations: This is the first study directly comparing DeCi and MaCi in a European adult population. The study's strengths include its prospective multicenter design, large sample size, and use of validated tools for outcome evaluation, which enhance the reliability and generalizability of the results. However, the non-randomized design, the age difference between groups, the testing of only one circumcision device model, and the lack of a cost-effectiveness analysis limit the generalizability of the findings.

Conclusion: In adult European men, DeCi offers superior aesthetic results and a similar safety profile compared to MaCi, though further research is needed to address the study's limitations.