Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Study Overview
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Brief Summary
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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.

Official Title
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Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

Conditions
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Circumcision

Intervention / Treatment
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* Device: Bipolar Electrosurgery
* Device: Thermocautery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circumcision, Electrosurgery, Thermocautery