Circumcision With Use of Thermocautery and Histopathological Changes

NCT ID: NCT04092998

Last Updated: 2019-09-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-05-20

Brief Summary

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Histo pathological changes that occurs in thermo cautery circumcision and the range of damage prepuce from thermal effect in comparison with scalpel circumcision

Detailed Description

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Circumcision is one of the most commonly performed surgical procedures worldwide. It is known that more than one million children are circumcised annually in the USA alone . Moreover, the WHO has begun to recommend circumcision on the basis of studies indicating its positive effects on human health and especially its role in protection from AIDS . Because of this, thousands of people have been circumcised by many migratory circumcision teams, especially in Africa.

Considering that 1 200 000 children are born annually in Turkey and 51% of them are male, on the basis of data from the Turkish Institute of Statistics, it may be speculated that about 60 000 circumcisions are performed annually in Turkey.

However, the circumcision procedure cannot be performed in health institutions as a routine procedure because of health regulations. When the Social Security Institute incorporated circumcision into the social insurance coverage in 2007, it led to circumcision being performed in the health institutions. Health institutions that were already burdened cannot meet the demands for circumcision. Thus, the search has begun for faster and reliable circumcision techniques with fewer complications. The present study aimed to compare bipolar thermal cautery-assisted circumcision technique, considered to be capable of meeting such demands, with the classical circumcision technique.

Aim of Work This study is aiming to assess the outcome of using thermo cautery in circumcision

Surgical Steps:

small skin incision over prepuce by thermo cautery

stitching if there is bleeding

Insertion of a urinary catheter if suspect uretheral injury

Conditions

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Circumcision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

male infant presented for Circumcision
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thermocautery VS scalpel circumcision

Thermocautery circumcision in comparison to circumcision with traditional scalpel

Group Type EXPERIMENTAL

Thermocautery circumcision

Intervention Type PROCEDURE

Histopathological changes from thermocautery circumcision

Interventions

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Thermocautery circumcision

Histopathological changes from thermocautery circumcision

Intervention Type PROCEDURE

Other Intervention Names

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scalpel circumcision

Eligibility Criteria

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Inclusion Criteria

* all male gender

Exclusion Criteria

* females
* micro penis
* hypospedias
* epispedias
* ambigilious genitalia
Minimum Eligible Age

40 Days

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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mohamed gamal

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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gamal makhlouf

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed gamal

Role: CONTACT

01007717127

Other Identifiers

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Circumcision

Identifier Type: -

Identifier Source: org_study_id

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