CClinicalTrials.gg
Status unknownNCT04092998Updated Sep 20, 2019

Circumcision With Use of Thermocautery and Histopathological Changes

An interventional study of Thermocautery circumcision in Circumcision, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to male participants aged 40 Days and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
40 Days and older
Sex
Male
01

Study summary

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

Read the 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

02

Conditions studied

  • Circumcision
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Days and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • all male gender

Exclusion criteria

Exclusion Criteria:

  • females
  • micro penis
  • hypospedias
  • epispedias
  • ambigilious genitalia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Thermocautery VS scalpel circumcision

    Thermocautery circumcision in comparison to circumcision with traditional scalpel

    Procedure: Thermocautery circumcision

Interventions

  • ProcedureThermocautery circumcision

    Histopathological changes from thermocautery circumcision

    Also known as: scalpel circumcision

06

What researchers measure

Primary outcomes

  1. early wound complications

    wound infection (with or without removal of the mesh) wound necrosis wound hematoma bleeding

    Time frame: 1 week

  2. late wound complications

    wound infection (with or without removal of the mesh) wound necrosis wound hematoma

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Assiut university
    Assiut, 71511, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — age , sex , clinical diagnosis

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04092998
Lead sponsor
Assiut University
Responsible party
mohamed gamal (Assistant lecturer, Assiut University) — Principal investigator
First posted
Sep 17, 2019
Start date
Oct 1, 2019 (estimated)
Primary completion
Oct 20, 2020 (estimated)
Completion
May 20, 2022 (estimated)
Last update
Sep 20, 2019

Study contacts

mohamed gamal
Contact
mohamedgamalhassan0@gmail.com
01007717127
gamal makhlouf
study director · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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