Comparison of Outcomes of Circumcision Via Open and Plastibell Methods

NCT ID: NCT06120634

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2020-10-31

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.

Conditions

Circumcision, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Open surgical method

In this group, the participants were circumcised using the open method. A total of 304 patients were enrolled in this group.

Group Type: ACTIVE_COMPARATOR

Open surgical method

Intervention Type: PROCEDURE

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

A total of 304 patients were enrolled in this group and underwent the process of circumcision by the Plastibell method.

Group Type: ACTIVE_COMPARATOR

Plastibell method

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 60 Months
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tehsil Headquarter Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ali Kamran

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Kamran, FCPS

Role: PRINCIPAL_INVESTIGATOR

Tehsil Headquarters Hospital Ferozewala, Sheikhupura, Punjab

Locations

Tehsil Headquarters Hospital Ferozewala

Sheikhupura, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

794/MS/THQ/FW

Identifier Type: -

Identifier Source: org_study_id