Comparison of Outcomes of Circumcision Via Open and Plastibell Methods

NCT06120634 | Completed DMC

• 1 other identifier: 794/MS/THQ/FW
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 1

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.

Conditions

Circumcision, Male

Keywords

Circumcision; Open method; Plastibell method; Complications; Outcomes; Parental response

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Ease of care

  From post-operative day 0 to day+30

• Satisfaction with cosmetic appearance

  From post-operative day 0 to day+30

Study Arms (2)

Open surgical method

ACTIVE COMPARATOR

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

Plastibell method

ACTIVE COMPARATOR

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

Procedure: Plastibell method

Interventions

Open surgical method 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.

Open surgical method

Plastibell method 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.

Plastibell method

Eligibility Criteria

• Age: 1 Month - 60 Months
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehsil Headquarter Hospital: lead

Study Sites (1)

Tehsil Headquarters Hospital Ferozewala

Sheikhupura, Punjab Province, Pakistan

Location

Study Officials

• Ali Kamran, FCPS

  Tehsil Headquarters Hospital Ferozewala, Sheikhupura, Punjab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: November 7, 2023
• Study Start: July 2, 2018
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)