Skip to main content
OpenTrials
Completed

NCT Number: NCT05590052

Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

1 month–12 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bipolar Electrosurgery

Device

Achievement of hemostasis using bipolar electrosurgery

Thermocautery

Device

achievement of hemostasis using thermocautery

Primary outcomes

  1. Mean and Standard deviation of postoperative analgesic doses (mean±SD)

    Time frame: 72 hours after the end of the operation

    Number of analgesic doses given after the end of the operation

Secondary outcomes

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

    Time frame: 2 minutes after the end of the operation

    Time from holding the penis till dresssing of the penis

  2. Number of participants and Rate of Intraoperative complications

    Time frame: 2 minutes after the end of the operation

    Number of participants and Rate of: Tachycardia, Bradycardia, Laryngeal spasm, Hypoxia, Bleeding, Glans injury, and Vomiting.

  3. Number of participants and Rate of Postoperative complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.