Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

NCT05590052 | Completed

• 1 other identifier: DTH: 22003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Circumcision

Keywords

Circumcision; Electrosurgery; Thermocautery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean and Standard deviation of Operative duration (minutes) (mean±SD)

  2 minutes after the end of the operation

• Number of participants and Rate of Intraoperative complications

  2 minutes after the end of the operation

• Number of participants and Rate of Postoperative complications

  4 weeks after the end of the operation

Study Arms (2)

Bipolar Electrosurgery group (n=60)

ACTIVE COMPARATOR

Group A

Device: Bipolar Electrosurgery

Thermocautery group (n=60)

ACTIVE COMPARATOR

Group B

Device: Thermocautery

Interventions

Bipolar Electrosurgery DEVICE

Achievement of hemostasis using bipolar electrosurgery

Bipolar Electrosurgery group (n=60)

Thermocautery DEVICE

achievement of hemostasis using thermocautery

Thermocautery group (n=60)

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour Teaching Hospital: lead

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Ahmed M Shaat, MD

  Damanhour Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: September 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: January 18, 2023

Record last verified: 2022-09

Locations

EG (1)