NCT07056452

Hydrodissection Circumcision Versus Conventional Circumcision

Hydrodissection Circumcision Versus Conventional Circumcision: A Randomized Trial Evaluating Efficacy, Safety, and Patient Outcomes in Male Circumcision

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 96 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: Male
• Age: 6 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Over a period of more than 3 years (January 2021 to February 2024), 96 males (aged 6-35 years; average 12.3 years) who underwent circumcision were randomly divided into three groups: HC, sCC (tissue sparing), and uCC (tissue unsparing), with a follow-up period exceeding 1 year. The HC group used physiological saline containing 0.5% lidocaine for hydrodissection, while the CC group did not have a hydrodissection step. Outcome Measurements and Statistical Analysis: Primary outcomes: operation time, intraoperative bleeding, postoperative pain and wound healing time. Secondary outcomes: intraoperative pain, postoperative complications and cosmetic results. The statistical analysis of results follows the randomized case-control trial (RCT) analysis method.

Detailed description

Participants were randomized 1:1:1 to the hydrodissection or conventional group using computer-generated random numbers. Surgeons and patients were blinded to group allocation until the procedure began. Based on the previous research results, with reference to the mean and standard deviation range, the sample size is calculated to be at least 28 cases per group (α=0.05, β=0.2). Considering the proportion of lost to follow-up, we selected 32 patients per group.

Conditions

• Circumcision

Interventions

Type	Name	Description
PROCEDURE	hydrodissection technique	injecting a solution of physiological saline containing 0.5% lidocaine along the cutting line

Timeline

• Start date: 2021-01-07
• Primary completion: 2024-02-07
• Completion: 2024-02-07
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

2 sites across 1 country: China