Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Not Applicable

Completed

• Conditions: Circumcision
• Interventions: Device: Thermocautery; Device: Bipolar Electrosurgery

• Registration Number: NCT05590052
• Lead Sponsor: Damanhour Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermocautery group (n=60)	Thermocautery	Group B
Bipolar Electrosurgery group (n=60)	Bipolar Electrosurgery	Group A

Primary Outcome Measures

Name	Time	Method
Mean and Standard deviation of postoperative analgesic doses (mean±SD)	72 hours after the end of the operation	Number of analgesic doses given after the end of the operation

Secondary Outcome Measures

Name	Time	Method
Mean and Standard deviation of Operative duration (minutes) (mean±SD)	2 minutes after the end of the operation	Time from holding the penis till dresssing of the penis
Number of participants and Rate of Intraoperative complications	2 minutes after the end of the operation	Number of participants and Rate of: Tachycardia, Bradycardia, Laryngeal spasm, Hypoxia, Bleeding, Glans injury, and Vomiting.
Number of participants and Rate of Postoperative complications	4 weeks after the end of the operation	Number of participants and Rate of: Bleeding requiring surgical intervention, Penile edema, Wound infection, Meatal stenosis, and Trapped penis.

Trial Locations

Locations (1)

Damanhour Teaching Hospital; 🇪🇬 Damanhūr, El-Beheira, Egypt