Comparison of Outcomes of Circumcision Via Open and Plastibell Methods

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

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.

Study Overview

• Status: Completed
• Conditions: Circumcision, Male
• Intervention / Treatment: Procedure: Open surgical method; Procedure: Plastibell method

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.

• Study Type: Interventional
• Enrollment (Actual): 608
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Sheikhupura, Punjab, Pakistan
      • Tehsil Headquarters Hospital Ferozewala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open surgical method; In this group, the participants were circumcised using the open method. A total of 304 patients were enrolled in this group.	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.
Active Comparator: Plastibell method; A total of 304 patients were enrolled in this group and underwent the process of circumcision by the Plastibell method.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative bleeding	Bleeding from the site of circumcision	From post-operative day 0 to day+30
Post-operative urinary retention	Urinary retention by the patient as reported by the parents/guardians/caregivers	From post-operative day 0 to day+30
Infection	Swelling, pain, redness, warm to touch as felt by the parents/guardians/caregivers	From post-operative day 0 to day+30
Over circumcision	Total number of participants with extra skin removed during the circumcision than required	From post-operative day 0 to day+30
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
Bell impaction	Number of participants with the head of the penis gets stuck to the Plastibell	From post-operative day 0 to day+30
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tehsil Headquarter Hospital
• Investigators: Principal Investigator: Ali Kamran, FCPS, Tehsil Headquarters Hospital Ferozewala, Sheikhupura, Punjab

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: November 4, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Outcomes; Complications; Circumcision; Open method; Plastibell method; Parental response
• Other Study ID Numbers: 794/MS/THQ/FW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No