Comparison of Outcomes of Circumcision Via Open and Plastibell Methods

Sponsor

Tehsil Headquarter Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06120634

Collaborator

(none)

608

Enrollment

Location

Arms

Actual Duration (Months)

21.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Circumcision, Male	Procedure: Open surgical method Procedure: Plastibell method	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

608 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jul 2, 2018

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Post-operative bleeding [From post-operative day 0 to day+30]
Bleeding from the site of circumcision
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
Over circumcision [From post-operative day 0 to day+30]
Total number of participants with extra skin removed during the circumcision than required
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
Bell impaction [From post-operative day 0 to day+30]
Number of participants with the head of the penis gets stuck to the Plastibell
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
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 60 Months

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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