Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

January 16, 2023 updated by: Damanhour Teaching Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Beheira
      • Damanhūr, El-Beheira, Egypt
        • Damanhour Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bipolar Electrosurgery group (n=60)
Group A
Device: Bipolar Electrosurgery
Achievement of hemostasis using bipolar electrosurgery
Active Comparator: Thermocautery group (n=60)
Group B
Device: Thermocautery
achievement of hemostasis using thermocautery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours after the end of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 minutes after the end of the operation
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.
2 minutes after the end of the operation
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.
4 weeks after the end of the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DTH: 22003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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