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

 
Research Protocol: A Comparative Study of the Advantages of 
Water-Separation Circumcision  
 
Study Title: Comparative Evaluation of Hydrodissection circumcision vs. 
Traditional Circumcision Techniques: A Randomized Controlled Trial 
 
1. Study Objective: The objective of this study is to compare the 
clinical outcomes and advantages of water-separation circumcision 
(Group A) versus two traditional circumcision techniques (Group B: 
"Subcutaneous Tissue Sparing "and Group C: "Non-Subcutaneous 
Tissue Sparing ") in male patients.  
2. Background and Rationale: Circumcision is one of the most 
commonly performed surgical procedures globally. Several techniques 
exist, including those that preserve or remove subcutaneous tissues. A 
newer method, water-separation circumcision, is being introduced as a 
potential improvement. This study aims to evaluate its effectiveness in 
terms of complications, healing time, and patient satisfaction, 
comparing it with traditional circumcision techniques. 
3. Study Design: This is a prospective, randomized controlled trial 
designed to evaluate the clinical outcomes of water-separation 
circumcision (Group A) compared to two traditional circumcision 
techniques (Group B and Group C). 

4. Inclusion Criteria: 
① Complies with the diagnostic criteria for phimosis, foreskin 
elongation, and related diseases in the "Chinese Expert 
Consensus on Phimosis, Foreskin related Diseases";  
② Preoperative routine examination showed no abnormalities in 
coagulation, blood 
routine, 
electrocardiogram and other 
indicators;  
③ No severe genital herpes, gonorrhea, syphilis, glans infection, 
etc.;  
④ Complies with the indications for sleeve type circumcision;  
⑤ The patient or family member is aware of the surgical plan and 
signs the informed consent form. 
5. Exclusion Criteria: 
① Patients with concomitant urethral malformations, such as 
hypospadias; 
② Patients with combined inflammation of the penis, prior penile 
surgery, severe adhesions, buried penis, and short frenulum of 
the penis;  
③ Exclude individuals with combined allergies or allergies to 
multiple medications; 
④ Patients with severe physical illnesses such as heart and lung 
dysfunction who cannot tolerate surgery;  

⑤ Individuals with cognitive impairments or mental abnormalities;  
⑥ Diabetes with poor glycemic control；  
⑦ Age >35 or Age<6.  
6. Intervention Groups: 
Group A (Hydrodissection circumcision): This group will undergo the 
water-separation circumcision technique, where water is used to separate 
the skin from the underlying tissues before performing the circumcision 
(HC). 
Group B (Subcutaneous Tissue Sparing Circumcision): 
This group will undergo a traditional circumcision procedure where the 
subcutaneous tissue is preserved, aiming for less scarring and quicker 
healing (sCC). 
Group C (Non-Subcutaneous Tissue Sparing Circumcision): 
This group will undergo the traditional circumcision procedure in which 
the subcutaneous tissue is not sparing (uCC). 
7. Outcome Measures: 
Primary Outcome Measure: 
1. operation time 
Operative time was calculated by timer. 
[Time Frame: 1 day] 
2. 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] 
3. 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] 
4. 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] 
Secondary Outcome Measures: 
5. other complications 

incidence rate 
[Time Frame: through study completion, an average of 1 year] 
6. 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] 
8. Sample Size Calculation: 
Given an assumed type I error (α) of 0.05 and type II error (β) of 0.20, 
a power of 80% is desired to detect a significant difference in the 
primary outcome (complication rate). Using a conservative estimate 
based on previous studies of circumcision complication rates, a 
sample size of 96 patients (32 patients per group) will provide 
sufficient power to detect differences between the three techniques. 
This sample size assumes a 10% dropout rate, so 96 patients will be 
recruited in total. 
9. Randomization: 
Randomization will be performed using a computer-generated 
randomization list, ensuring that each participant has an equal chance 
of being assigned to one of the three groups. Stratified randomization 

will be used to ensure balance across demographic variables (e.g., age, 
baseline health status). Patients will be blinded to group assignment, 
and the surgical team will remain unaware of the group allocation to 
reduce bias. 
10. Statistical Analysis: 
Data will be analyzed using the Statistical Package for the Social 
Sciences (SPSS) software, version 26 (or newer). The following 
statistical methods will be applied:                     
Descriptive statistics (mean, standard deviation, frequency 
distributions) will be used for demographic data and outcome 
measures.                                         
Chi-square tests will be used to compare categorical variables (e.g., 
complication rates between the three groups).               
Analysis of variance (ANOVA) will be applied to compare 
continuous variables (e.g., healing time, pain scores) between groups.  
If assumptions of normality are violated, Kruskal-Wallis 
tests (non-parametric version of ANOVA) will be used. 
Post-hoc tests (e.g., Tukey's test) will be applied where significant 
differences are found in the ANOVA. Kaplan-Meier survival 
analysis will be used to assess time to healing (i.e., complete wound 
closure). P-values of < 0.05 will be considered statistically 

significant. Confidence intervals (95%) will be reported for all 
continuous outcomes. 
11. Ethical Considerations: The study will be conducted in accordance 
with the Declaration of Helsinki and will be approved by the 
Chongqing Jiulongpo Hospital ethics committee. All patients will 
provide written informed consent prior to participation, and their 
rights, confidentiality, and well-being will be ensured throughout the 
study. The clinical trial will be registered in a public database. 
12. Timeline:  
Study start date: 2019-6-30 
Study end date: 2024-2-07 
Recruitment period: 3 months 
Follow-up period: 1 year after surgery 
13. Budget Considerations:  
Personnel costs (surgeons, nurses, data managers):  
1000 x 96=96000RMB 
Materials and Equipment (surgical tools, sutures, bandages, anesthesia)  
500 x 96=48000RMB 
Statistical and software tools: 1000 RMB 
Participant compensation for time and travel:  
1000 X96=96000 RMB 
 

Principal Investigator: [Liu Wujiang] 
Study Coordinators: [Yang Chunfei] 
Contact Information: [Department of Urology, 
Peking 
University 
First 
Hospital, 
86 
13910901659]