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Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05590052
Enrollment
120
Registered
2022-10-21
Start date
2022-09-01
Completion date
2023-01-15
Last updated
2023-01-18

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

Conditions

Circumcision

Keywords

Circumcision, Electrosurgery, Thermocautery

Brief summary

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.

Interventions

DEVICEBipolar Electrosurgery

Achievement of hemostasis using bipolar electrosurgery

achievement of hemostasis using thermocautery

Sponsors

Damanhour Teaching Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
1 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean and Standard deviation of postoperative analgesic doses (mean±SD)72 hours after the end of the operationNumber of analgesic doses given after the end of the operation

Secondary

MeasureTime frameDescription
Mean and Standard deviation of Operative duration (minutes) (mean±SD)2 minutes after the end of the operationTime from holding the penis till dresssing of the penis
Number of participants and Rate of Intraoperative complications2 minutes after the end of the operationNumber of participants and Rate of: Tachycardia, Bradycardia, Laryngeal spasm, Hypoxia, Bleeding, Glans injury, and Vomiting.
Number of participants and Rate of Postoperative complications4 weeks after the end of the operationNumber of participants and Rate of: Bleeding requiring surgical intervention, Penile edema, Wound infection, Meatal stenosis, and Trapped penis.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026