Comparison of Outcomes of Circumcision Via Open and Plastibell Methods

Circumcision, Male Clinical Trial

Official title:

A Quasi-experimental Study Comparing Outcomes and Parent's Responses in 600+ Circumcised Boys in a Lower-Middle Income Country

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06120634
• Other study ID #: 794/MS/THQ/FW
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2023
• Source: Tehsil Headquarter Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 608
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 1 Month to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Circumcision, Male

Intervention

Procedure:
• Open surgical method
After separating the preputial skin from glans and removing smegma, two artery clips were applied on the dorsal skin in the center to mark the skin to be divided. Crushing the skin for a couple of minutes, prior to incising, helps to reduce bleeding. The skin was cut about 2-3 mm short of the coronal sulcus. Similarly, 2-3 mm cuff of prepuce was circumferentially cut proximal to the corona. Using bipolar diathermy or catgut 4/0, frenular artery along with dorsal artery and vein of penis were coagulated or ligated respectively to achieve hemostasis. The skin and prepuce were approximated and sutured with catgut 4/0 at four places- ventral, dorsal, and two lateral points. Finally, a dressing with antibiotic ointment was applied to the wound.
• Plastibell method
The prepuce was separated all around the glans, up to the coronal sulcus, and smegma was removed. A dorsal slit in the skin was made, after crushing the skin for a couple of minutes, long enough to accommodate the passage of an appropriate-sized plastibell. Once the distal edge of the bell snugly fit at or near the coronal sulcus, a ligature was applied and tightened around the sulcus on the bell. The extra preputial skin was cut with either scissors or a surgical blade, after breaking apart and discarding the handle of the plastibell. The urethral meatus was examined and its visibility was ensured prior to returning the baby boy to his parents. The baby was kept under observation for 30 minutes in the surgical ward and re-examined to ensure there was no hematoma or bleeding.

Locations

Country	Name	City	State
Pakistan	Tehsil Headquarters Hospital Ferozewala	Sheikhupura	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Tehsil Headquarter Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative bleeding	Bleeding from the site of circumcision	From post-operative day 0 to day+30
Primary	Post-operative urinary retention	Urinary retention by the patient as reported by the parents/guardians/caregivers	From post-operative day 0 to day+30
Primary	Infection	Swelling, pain, redness, warm to touch as felt by the parents/guardians/caregivers	From post-operative day 0 to day+30
Primary	Over circumcision	Total number of participants with extra skin removed during the circumcision than required	From post-operative day 0 to day+30
Primary	Under circumcision	Number of participants with less skin removed during the circumcision covering half of glans penis	From post-operative day 0 to day+30
Primary	Bell impaction	Number of participants with the head of the penis gets stuck to the Plastibell	From post-operative day 0 to day+30
Primary	Delayed shedding of the ring	Number of participants with failure of Plastibell to shed on its own	From post-operative day 0 to day+10
Primary	Post-procedural phimosis/paraphimosis	Number of participants with entrapment of a retracted foreskin behind the coronal sulcus	From post-operative day 0 to day+30
Secondary	Ease of care	total number of Parents' ease in the change of diapers, clothes, and giving bath to the baby assessed subjectively through interview of parents	From post-operative day 0 to day+30
Secondary	Satisfaction with cosmetic appearance	Total number of parents satisfied with the appearance of penis after the circumcision	From post-operative day 0 to day+30