Circumcision With Use of Thermocautery and Histopathological Changes

Histopathological Changes and Surgical Complications in Thermocautery Circumcision

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

Study Overview

• Status: Unknown
• Conditions: Circumcision
• Intervention / Treatment: Procedure: Thermocautery circumcision

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• all male gender

Exclusion Criteria:

• females
• micro penis
• hypospedias
• epispedias
• ambigilious genitalia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermocautery VS scalpel circumcision; Thermocautery circumcision in comparison to circumcision with traditional scalpel	Procedure: Thermocautery circumcision; Histopathological changes from thermocautery circumcision; Other Names: scalpel circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late wound complications	wound infection (with or without removal of the mesh) wound necrosis wound hematoma	1 month
early wound complications	wound infection (with or without removal of the mesh) wound necrosis wound hematoma bleeding	1 week

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: gamal makhlouf, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 20, 2020
• Study Completion (Anticipated): May 20, 2022

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Circumcision

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: age , sex , clinical diagnosis
• IPD Sharing Time Frame: 3 years
• IPD Sharing Access Criteria: age , sex , clinical diagnosis
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No