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.
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.
Study Type
OBSERVATIONAL
Enrollment
96
injecting a solution of physiological saline containing 0.5% lidocaine along the cutting line
Deparment of Urology, Peking University First Hospital
Beijing, Beijing Municipality, China
Chongqing Jiulongpo District Maternal and Child Health Hospital
Chongqing, Chongqing Municipality, China
operation time
Operative time was calculated by timer.
Time frame: 1 day
intraoperative bleeding
The amount of intraoperative bleeding is calculated by weighing gauze before and after operation. 1 milliliter is approximately equal to the weight of 1 gram.
Time frame: 1 day
The healing time
The healing time was judged by the doctors based on the observation of the wound and inquiry of the patients during 7-25 days after surgery. We defined complete wound healing as the absence of a scab with a completely epithelialized and dry skin surface based on clinical assessment
Time frame: 7-25 days
Intra-operative pain
Intra-operative pain was graded immediately after the operation while the post-operation pain was graded at 1 week by NRS (Numeric Rating Scale). The scale typically ranges from 0 to 10. 0 indicates no pain, while 10 signifies the most severe pain imaginable.
Time frame: 1 day
other complications
incidence rate
Time frame: through study completion, an average of 1 year
patient satisfaction
Patient satisfaction is divided into 5 levels：Extremely dissatisfied，Dissatisfied，Neutral，Satisfied，Extremely Satisfied.
Time frame: through study completion, an average of 1 year
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