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Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

D

Damanhour Teaching Hospital

Status

Completed

Conditions

Circumcision

Treatments

Device: Bipolar Electrosurgery
Device: Thermocautery

Study type

Interventional

Funder types

Other

Identifiers

NCT05590052
DTH: 22003

Details and patient eligibility

About

Background: Circumcision is the most commonly performed surgical procedure done among the pediatric age group worldwide and is considered to be one of the oldest operations done. Circumcision should be performed properly with safe surgical techniques, with the least possibility of complications.

Objective: To compare bipolar electrosurgery versus thermocautery in the circumcision of infants under combined general and local anesthesia.

Patients and Methods: This prospective randomized comparative study was carried out on 110 infants who were candidates for elective circumcision under combined general and local anesthesia. Infants were randomly allocated into two equal groups (55 infants each); in group A, circumcised by bone-cutting forceps with cutting foreskin using a scalpel and achievement of hemostasis using bipolar electrosurgery, and in group B, circumcised by bone-cutting forceps with cutting foreskin and achievement of hemostasis using thermocautery.

Enrollment

120 patients

Sex

Male

Ages

1 to 12 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infants of families who applied for circumcision
  • Age from 1 to 12 months, of the male sex
  • Infants should have normal preoperative laboratory investigations

Exclusion criteria

  • Infants with congenital malformations especially hypospadias and epispadias, congenital inguinal hernia, and undescended testis
  • Infants with acute penile infection, or excess suprapubic fat
  • Infants with cardiovascular, neurological, respiratory, liver, renal, endocrine, blood, or immune diseases
  • Allergy to any drug will be used in this study

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

Bipolar Electrosurgery group (n=60)
Active Comparator group
Description:
Group A
Treatment:
Device: Bipolar Electrosurgery
Thermocautery group (n=60)
Active Comparator group
Description:
Group B
Treatment:
Device: Thermocautery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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