Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques

NCT ID: NCT05590052

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-01-15

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.

Detailed Description

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Conditions

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Circumcision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bipolar Electrosurgery group (n=60)

Group A

Group Type ACTIVE_COMPARATOR

Bipolar Electrosurgery

Intervention Type DEVICE

Achievement of hemostasis using bipolar electrosurgery

Thermocautery group (n=60)

Group B

Group Type ACTIVE_COMPARATOR

Thermocautery

Intervention Type DEVICE

achievement of hemostasis using thermocautery

Interventions

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Bipolar Electrosurgery

Achievement of hemostasis using bipolar electrosurgery

Intervention Type DEVICE

Thermocautery

achievement of hemostasis using thermocautery

Intervention Type DEVICE

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Damanhour Teaching Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed M Shaat, MD

Role: PRINCIPAL_INVESTIGATOR

Damanhour Teaching Hospital

Locations

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Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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DTH: 22003

Identifier Type: -

Identifier Source: org_study_id

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