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| ID | Type | Description | Link |
|---|---|---|---|
| 510212197105014555 | Registry Identifier | Liu Wujiang |
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| Name | Class |
|---|---|
| Chongqing Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Control Group | This group has not hydrodissection but has tissue sparing | ||
| Arm2: Control Group | This group has not hydrodissection and also hasn't tissue sparing | ||
| Arm3: Hydrodissection circumcision | By injecting a solution of physiological saline containing 0.5% lidocaine along the cutting line , the hydrodissection technique creates a natural plane of separation, facilitating precise and minimally invasive skin removal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrodissection technique | Procedure | injecting a solution of physiological saline containing 0.5% lidocaine along the cutting line |
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| Measure | Description | Time Frame |
|---|---|---|
| operation time | Operative time was calculated by timer. | 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. | 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 | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| other complications | incidence rate | through study completion, an average of 1 year |
| patient satisfaction | Patient satisfaction is divided into 5 levels：Extremely dissatisfied，Dissatisfied，Neutral，Satisfied，Extremely Satisfied. |
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Inclusion Criteria:
Exclusion Criteria:
male
Outpatient patient requests circumcision
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| Name | Affiliation | Role |
|---|---|---|
| Wujiang Liu | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Urology, Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
All follow up data
1 year after publication
All interested doctors, professors, and scholars
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2023 | Mar 24, 2025 | Prot_000.pdf |
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| through study completion, an average of 1 year |
| Chongqing Jiulongpo District Maternal and Child Health Hospital |
| Chongqing |
| Chongqing Municipality |
| 632000 |
| China |