NCT04092998

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 16, 2019

Last Update Submit

September 19, 2019

Conditions

Circumcision

Outcome Measures

Primary Outcomes (2)

  • early wound complications

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

    1 week

  • late wound complications

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

    1 month

Study Arms (1)

Thermocautery VS scalpel circumcision

EXPERIMENTAL

Thermocautery circumcision in comparison to circumcision with traditional scalpel

Procedure: Thermocautery circumcision

Interventions

Thermocautery circumcisionPROCEDURE

Histopathological changes from thermocautery circumcision

Also known as: scalpel circumcision
Thermocautery VS scalpel circumcision

Eligibility Criteria

Age40 Days+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale infant
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all male gender

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71511, Egypt

RECRUITING

Study Officials

  • gamal makhlouf

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

mohamed gamal

CONTACT

01007717127mohamedgamalhassan0@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: male infant presented for Circumcision
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 17, 2019

Study Start

October 1, 2019

Primary Completion

October 20, 2020

Study Completion

May 20, 2022

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

age , sex , clinical diagnosis

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 years
Access Criteria
age , sex , clinical diagnosis

Locations

EG(1)