Clinical trial NCT06120634: Comparison of Outcomes of Circumcision Via Open and Plastibell Methods
Official title: A Quasi-experimental Study Comparing Outcomes and Parent's Responses in 600+ Circumcised Boys in a Lower-Middle Income Country
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision, Male
Keywords: Circumcision
Open method
Plastibell method
Complications
Outcomes
Parental response
Lead sponsor: Tehsil Headquarter Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-07
Enrollment: 608
Sex: MALE
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Healthy males up to 5 years of age
* Signed, informed consent of parents/guardians

Exclusion Criteria:

* 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

Primary outcomes:
measure: Post-operative bleeding
timeFrame: From post-operative day 0 to day+30
measure: Post-operative urinary retention
timeFrame: From post-operative day 0 to day+30
measure: Infection
timeFrame: From post-operative day 0 to day+30
measure: Over circumcision
timeFrame: From post-operative day 0 to day+30
measure: Under circumcision
timeFrame: From post-operative day 0 to day+30
measure: Bell impaction
timeFrame: From post-operative day 0 to day+30
measure: Delayed shedding of the ring
timeFrame: From post-operative day 0 to day+10
measure: Post-procedural phimosis/paraphimosis
timeFrame: From post-operative day 0 to day+30
Secondary outcomes:
measure: Ease of care
timeFrame: From post-operative day 0 to day+30
measure: Satisfaction with cosmetic appearance
timeFrame: From post-operative day 0 to day+30
Other outcomes:
Locations:
city: Sheikhupura
country: Pakistan
facility: Tehsil Headquarters Hospital Ferozewala
state: Punjab
Study officials:
affiliation: Tehsil Headquarters Hospital Ferozewala, Sheikhupura, Punjab
name: Ali Kamran, FCPS
role: PRINCIPAL_INVESTIGATOR
References: