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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04092998
Other study ID # Circumcision
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date May 20, 2022

Study information

Verified date September 2019
Source Assiut University
Contact mohamed gamal
Phone 01007717127
Email mohamedgamalhassan0@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 20, 2022
Est. primary completion date October 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Days and older
Eligibility Inclusion Criteria:

- all male gender

Exclusion Criteria:

- females

- micro penis

- hypospedias

- epispedias

- ambigilious genitalia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Thermocautery circumcision
Histopathological changes from thermocautery circumcision

Locations

Country Name City State
Egypt Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary early wound complications wound infection (with or without removal of the mesh) wound necrosis wound hematoma bleeding 1 week
Primary late wound complications wound infection (with or without removal of the mesh) wound necrosis wound hematoma 1 month
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