Circumcision
Conditions
Keywords
Circumcision, Hydrodissection, HC, sCC, uCC
Brief 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.
Interventions
PROCEDUREhydrodissection technique
injecting a solution of physiological saline containing 0.5% lidocaine along the cutting line
Sponsors
Chongqing Medical University
Peking University
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
6 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Complies with the diagnostic criteria for phimosis, foreskin elongation, and related diseases in the Chinese Expert Consensus on Phimosis, Foreskin related Diseases; * Preoperative routine examination showed no abnormalities in coagulation, blood routine, electrocardiogram and other indicators; * No severe genital herpes, gonorrhea, syphilis, glans infection, etc.; * Complies with the indications for sleeve type circumcision ; * The patient or family member is aware of the surgical plan and signs the informed consent form.
Exclusion criteria
* Patients with concomitant urethral malformations, such as hypospadias; * Patients with combined inflammation of the penis, prior penile surgery, severe adhesions, buried penis, and short frenulum of the penis; * Exclude individuals with combined allergies or allergies to multiple medications; * Patients with severe physical illnesses such as heart and lung dysfunction who cannot tolerate surgery; * Individuals with cognitive impairments or mental abnormalities; * Diabetes with poor glycemic control； * Age \>35 or Age\<6.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operation time | 1 day | Operative time was calculated by timer. |
| intraoperative bleeding | 1 day | 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. |
| The healing time | 7-25 days | 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 |
| Intra-operative pain | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| other complications | through study completion, an average of 1 year | incidence rate |
| patient satisfaction | through study completion, an average of 1 year | Patient satisfaction is divided into 5 levels：Extremely dissatisfied，Dissatisfied，Neutral，Satisfied，Extremely Satisfied. |
Countries
China
Outcome results
None listed