Circumcision, Male
Conditions
Keywords
Circumcision, Postoperative complications, Protection devices
Brief summary
Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. For post-circumcision patients, a flexible sleeve penile protection device was invented as a modification of the traditional gauze bandage. This study investigated the protective effect of the device by recruiting post-circumcision patients to use the device and collecting indicators related to post-operative recovery and patients' experience of using the device.
Detailed description
Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. Post-circumcision patients remain at risk of gauze detachment, wound pain and post-operative bleeding, leading to serious post-operative adverse effects, including complications such as dehiscence and infection. The investigators have invented a flexible sleeve penile protection device, which consists of two components, a flexible sleeve and a hood, the main function of the flexible sleeve is to stop bleeding with compression and immobilisation, and the main function of the hood is to provide protection to the head of the penis and prevent the wound from rubbing against clothing leading to pain. The aim of this study was to investigate the protective effect of a flexible sleeve penile protection device on post-circumcision patients in terms of gauze loosening and dislodging, post-operative pain and post-operative bleeding. This study was a prospective randomized controlled trial of patients who underwent circumcision at Peking University Third Hospital from February 2023 to May 2023. Patients in the experimental group were wrapped with this device postoperatively, while patients in the control group were wrapped with traditional gauze postoperatively. Patients were followed up regularly after surgery, and indicators such as complications, pain and recovery time were collected to investigate the protective effect of this device.
Interventions
OTHERwrapped with the Flexible Sleeve Penis Protection Device
Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. Patients in the control group were wrapped with traditional gauze post-operatively.
OTHERwrapped with traditional gauze
Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. Patients in the control group were wrapped with traditional gauze post-operatively.
Sponsors
Liu Zhuo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Patients in the experimental group were wrapped with this device postoperatively Patients in the control group were wrapped with traditional gauze postoperatively.
Eligibility
Sex/Gender
MALE
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed redundant prepuce and circumcised at Peking University Third Hospital. 2. Male patients aged between 12 and 60 years (inclusive). 3. The person or guardian fully understands and signs the informed consent form.
Exclusion criteria
1. Acute urinary and genital infections, such as acute urethritis, acute prostatitis, acute epididymitis, etc., or trauma. 2. Abnormal blood clotting function. 3. Those who are allergic to the materials used in the manufacture of the product. 4. Patients who are mentally incapable or unable to understand the requirements for participation in the study and have difficulty in cooperating. 5. Subjects who, in the opinion of the investigator, are unable to comply with follow-up, compromising the scientific validity and integrity of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complication | through study completion, an average of 12weeks | Assessing the incidence of post-operative complications |
| Foreskin edema score | through study completion, an average of 12weeks | Assessment of foreskin oedema which includes 0-6 points. A higher score means a more severe case of penile foreskin oedema |
| Healing time | through study completion, an average of 12weeks | Time for sutures to come off completely and time for wound healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound pain assessment | through study completion, an average of 12weeks | Using the Visual analogue scale ，which includes 0-10 points. A higher score means more pain |
| Comfort and convenience assessment | through study completion, an average of 12weeks | Comfort and convenience assessed by questionnaire |
Countries
China
Outcome results
None listed