Comparison of Outcomes of Circumcision Via Open and Plastibell Methods
- Conditions
- Circumcision, Male
- Interventions
- Procedure: Open surgical methodProcedure: Plastibell method
- Registration Number
- NCT06120634
- Lead Sponsor
- Tehsil Headquarter Hospital
- Brief Summary
Circumcision is considered one of the most common elective surgical procedures, particularly among Muslim and Jewish males. Of all the available techniques, Plastibell is gaining traction amongst surgeons due to its safety in the form of a lower complication rate. The current quasi-experimental study aimed to compare the Open and Plastibell methods of circumcision in a study population which comprised of boys up to 5 years of age who were grouped into the Open method and Plastibell based on parental preference. Follow-up occurred on the 5th, 10th, and, 30th post-procedural day. Basic demographic data, procedural duration, and outcomes were documented.
- Detailed Description
This study was conducted to compare the Open and Plastibell method of circumcision in boys up to 5-years of age, in terms of procedural time, outcomes and parental satisfaction.
This was a quasi-experimental study of boys up to 5-years of age. Boys meeting the inclusion criteria were categorized into two groups based on parental preference - Open method and Plastibell. Patients were followed-up on the 5th, 10th and 30th post-procedural day. Basic demographic data, procedural duration, and outcomes were documented.
Of 646 boys brought to the hospital for circumcision, 608 met the inclusion criteria with equal participants in both groups. The median age in Open and Plastibell groups was three and five months respectively. The median operating time was significantly shorter in the Plastibell group (4.2 min) compared to the Open method (13 min). Of the complications recorded in 91 children, more were observed in Plastibell group. Post-procedure bleeding occurred in 1.2% children (n=7). Open method resulted in infection, excessive skin removal (n=8 each) and urinary retention (n=7) whereas Plastibell impaction (n=21) and inadequate skin removal (n=19) were the commonest complications in the Plastibell group which were significantly associated with age of the boys. There were no serious adverse events. Open method was preferred by parents for cosmesis and Plastibell for ease of care.
It is concluded that Plastibell, compared to open method, is a quicker method of circumcision and is safe for boys up to 5-years of age, however, earlier circumcisions are associated with lesser complications. The follow-up ensures patient safety.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 608
- Healthy males up to 5 years of age
- Signed, informed consent of parents/guardians
- Boys with bleeding disorders, severe jaundice, or genital abnormalities like hypospadias, epispadias, congenital chordee.
- Whose parents did not give consent
- Boys with a larger glans size not feasible for Plastibell circumcision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open surgical method Open surgical method In this group, the participants were circumcised using the open method. A total of 304 patients were enrolled in this group. Plastibell method Plastibell method A total of 304 patients were enrolled in this group and underwent the process of circumcision by the Plastibell method.
- Primary Outcome Measures
Name Time Method Post-operative bleeding From post-operative day 0 to day+30 Bleeding from the site of circumcision
Under circumcision From post-operative day 0 to day+30 Number of participants with less skin removed during the circumcision covering half of glans penis
Post-procedural phimosis/paraphimosis From post-operative day 0 to day+30 Number of participants with entrapment of a retracted foreskin behind the coronal sulcus
Post-operative urinary retention From post-operative day 0 to day+30 Urinary retention by the patient as reported by the parents/guardians/caregivers
Infection From post-operative day 0 to day+30 Swelling, pain, redness, warm to touch as felt by the parents/guardians/caregivers
Bell impaction From post-operative day 0 to day+30 Number of participants with the head of the penis gets stuck to the Plastibell
Over circumcision From post-operative day 0 to day+30 Total number of participants with extra skin removed during the circumcision than required
Delayed shedding of the ring From post-operative day 0 to day+10 Number of participants with failure of Plastibell to shed on its own
- Secondary Outcome Measures
Name Time Method Ease of care From post-operative day 0 to day+30 total number of Parents' ease in the change of diapers, clothes, and giving bath to the baby assessed subjectively through interview of parents
Satisfaction with cosmetic appearance From post-operative day 0 to day+30 Total number of parents satisfied with the appearance of penis after the circumcision
Trial Locations
- Locations (1)
Tehsil Headquarters Hospital Ferozewala
🇵🇰Sheikhupura, Punjab, Pakistan