Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Circumcision Clinical Trial

Official title:

Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590052
• Other study ID #: DTH: 22003
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: September 2022
• Source: Damanhour Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Month to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Circumcision

Intervention

Device:
• Bipolar Electrosurgery
Achievement of hemostasis using bipolar electrosurgery
• Thermocautery
achievement of hemostasis using thermocautery

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean and Standard deviation of postoperative analgesic doses (mean±SD)	Number of analgesic doses given after the end of the operation	72 hours after the end of the operation
Secondary	Mean and Standard deviation of Operative duration (minutes) (mean±SD)	Time from holding the penis till dresssing of the penis	2 minutes after the end of the operation
Secondary	Number of participants and Rate of Intraoperative complications	Number of participants and Rate of: Tachycardia, Bradycardia, Laryngeal spasm, Hypoxia, Bleeding, Glans injury, and Vomiting.	2 minutes after the end of the operation
Secondary	Number of participants and Rate of Postoperative complications	Number of participants and Rate of: Bleeding requiring surgical intervention, Penile edema, Wound infection, Meatal stenosis, and Trapped penis.	4 weeks after the end of the operation