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Comparison between different circumcision techniques in neonates and infants

Comparison of post-operative pain between the Bone Cutter with Thermal Cautery, Gomco and Plastibell for Circumcision in Neonates and Infants: A prospective randomized trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000190404
Enrollment
150
Registered
2016-02-12
Start date
2014-01-01
Completion date
2015-01-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

this prospective randomized trial was conducted on 150 babies presented for routine circumcision. They were randomized and equally allocated into 3 groups; babies circumcised using the bone cutter forceps with thermal cautery (Group I), Gomco clamp 'Registered Trademark' (Group II) and the Plastibell device 'Registered Trademark' (Group III). Intraoperative details, postoperative pain and complications, cosmetic outcome, and parent satisfaction were recorded

Interventions

three different techniques were used for circumcision: Group 1: Bone Cutter with Thermal Cautery... the technique started by holding the skin by two hemostat was done to elevate the foreskin then application of the bone cutting forceps at the level of skin to be removed for circumcision. Cutting the excess foreskin was done using the heated thermal cautery. the skin was retracted proximally after cutting the excess foreskin to expose the glans. it usually takes 3-5 minutes. Group 2: will be circ

three different techniques were used for circumcision: Group 1: Bone Cutter with Thermal Cautery... the technique started by holding the skin by two hemostat was done to elevate the foreskin then application of the bone cutting forceps at the level of skin to be removed for circumcision. Cutting the excess foreskin was done using the heated thermal cautery. the skin was retracted proximally after cutting the excess foreskin to expose the glans. it usually takes 3-5 minutes. Group 2: will be circumcised using Gomco clamp. the procedure involves placement of special metal device formed of 2 parts; the first one cover the glans to protect it and the second one applied pressure at the line of supposed to be incised then removal of the excess skin was done. it usually takes 5-10 minutes. Group 3: will be circumcised using Plastibell device. its use involves the placement of a clear plastic ring over the glans, followed by trimming of the excess skin during a surgical procedure, and the device falls off within 3 to 7 days.

Sponsors

Ain shams university
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
1 Days to 90 Days
Healthy volunteers
Yes

Inclusion criteria

Babies presented for routine circumcision

Exclusion criteria

Bleeding tendency Liver diseases Neurological impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026