CircumcisionCircumcisionNCT07056452
Hydrodissection Circumcision Versus Conventional Circumcision
An observational study of Circumcision, run by Peking University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 35 years, men only
- Conditions the study is for
- Circumcision
- What is being tested?
- hydrodissection technique
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 2 sitesChina
- Study dates
- 7 Jan 2021to 7 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Outpatient patient requests circumcision
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Deparment of Urology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Chongqing Jiulongpo District Maternal and Child Health Hospital
Chongqing, Chongqing Municipality, 632000
About this study
Official title: Hydrodissection Circumcision Versus Conventional Circumcision: A Randomized Trial Evaluating Efficacy, Safety, and Patient Outcomes in Male Circumcision
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.
Read the 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
- Being tested
- hydrodissection technique
- Keywords
- Circumcision, Hydrodissection, HC, sCC, uCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrodissection techniqueProcedure or surgery
injecting a solution of physiological saline containing 0.5% lidocaine along the cutting line
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: hydrodissection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
Operative time was calculated by timer.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 day
Secondary outcomes (2)
other complications
incidence rate
Measured: through study completion, an average of 1 year
patient satisfaction
Patient satisfaction is divided into 5 levels：Extremely dissatisfied，Dissatisfied，Neutral，Satisfied，Extremely Satisfied.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start7 Jan 2021
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CircumcisionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Medical University
- Responsible party
- Principal investigator, Wujiang Liu, Peking University
- Investigators
- Wujiang Liu, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056452
- Sponsor's protocol ID
- CQJLPWCH-008
- Other IDs
- 510212197105014555
- Acronym
- Circumcision
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All follow up data
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrodissection Circumcision Versus Conventional Circumcision: A Randomized Trial Evaluating Efficacy, Safety, and Patient Outcomes in Male Circumcision
- ClinicalTrials.gov ID
- NCT07056452
- Acronym / sponsor ID
- Circumcision / CQJLPWCH-008
- Conditions
- Circumcision
- Keywords
- Circumcision, Hydrodissection, HC, sCC, uCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Chongqing Medical University
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: hydrodissection techniqueBy 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. |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Outpatient patient requests circumcision
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrodissection techniqueinjecting a solution of physiological saline containing 0.5% lidocaine along the cutting line | Procedure or surgery | Arm3: Hydrodissection circumcision |
Primary outcome
operation time
Time frame: 1 day
Operative time was calculated by timer.
intraoperative bleeding
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
other complications
Time frame: through study completion, an average of 1 year
patient satisfaction
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Yes. All follow up data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wujiang Liu principal investigator
Peking University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circumcision, run by Peking University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.