Hydrodissection Circumcision Versus Conventional Circumcision

Peking University

Status: Completed

Conditions: Circumcision

Treatments: Procedure: hydrodissection technique

Study type: Observational

Funder types: Other

Identifiers

NCT07056452

510212197105014555 (Registry Identifier)

CQJLPWCH-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: Male

Ages: 6 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

96 participants in 3 patient groups

Arm 1: Control Group

Description:

This group has not hydrodissection but has tissue sparing

Arm2: Control Group

Description:

This group has not hydrodissection and also hasn't tissue sparing

Arm3: Hydrodissection circumcision

Description:

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.

Treatment:

Procedure: hydrodissection technique