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Completed

NCT Number: NCT07056452

Hydrodissection Circumcision Versus Conventional 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.

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Key information

Conditions

Age range

6 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

Deparment of Urology, Peking University First Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hydrodissection technique

Procedure

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

Primary outcomes

  1. operation time

    Time frame: 1 day

    Operative time was calculated by timer.

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

  1. other complications

    Time frame: through study completion, an average of 1 year

    incidence rate

  2. patient satisfaction

    Time frame: through study completion, an average of 1 year

    Patient satisfaction is divided into 5 levels:Extremely dissatisfied,Dissatisfied,Neutral,Satisfied,Extremely Satisfied.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Chongqing Medical University

Registry information

Official study title

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

Acronym: Circumcision

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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