Hydrodissection Circumcision Versus Conventional Circumcision

NCT07056452 | Completed DMC

• 2 other identifiers: CQJLPWCH-008510212197105014555
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Circumcision

Keywords

Circumcision; Hydrodissection; HC; sCC; uCC

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• other complications

  through study completion, an average of 1 year

• patient satisfaction

  through study completion, an average of 1 year

Study Arms (3)

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.

Procedure: hydrodissection technique

Interventions

hydrodissection technique PROCEDURE

injecting a solution of physiological saline containing 0.5% lidocaine along the cutting line

Arm3: Hydrodissection circumcision

Eligibility Criteria

• Age: 6 Years - 35 Years
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Outpatient patient requests circumcision

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Chongqing Medical University: collaborator

Study Sites (2)

Deparment of Urology, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Chongqing Jiulongpo District Maternal and Child Health Hospital

Chongqing, Chongqing Municipality, 632000, China

Location

Study Officials

• Wujiang Liu

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: July 9, 2025
• Study Start: January 7, 2021
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: July 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year after publication
• Access Criteria: All interested doctors, professors, and scholars

Locations

CN (2)