This study is a single blind, randomized clinical trial. The purpose of this study is comparision between complications of conventional surgical circumcision without sutures and with sutures in children reffered to Imam Reza hospital of Kermanshah. 100 patients were randomized into two groups, circumcision Procedure without stitches and conventional. Inclusion criteria is all children referred for circumcision to Imam Reza hospital. The group operates without using sutures, after removing the foreskin and mucosal cuff, after sufficient hemostasis operation completed. In group with suture by using absorbable string, foreskin and mucosal cuff approximate. Patients in both groups will be followed for first week and first month, and will examine the effects of bleeding and infection. Data from the two groups will be compared in the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020512368N1
Registration date:2013-06-18, 1392/03/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-18, 1392/03/28
Registrant information
Name
Ardalan Solimani
Name of organization / entity
Kermanshah University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6332
Email address
dr.ar.solymany@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of suturless circumcision and conventional circumcision with suture
Public title
comparision between two methods of circumcision
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children referred for circumcision to Imam Reza Hospital.
Exclusion criteria: Children whose parents did not consent to circumcision procedure without suture.
Age
To 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for research, Kermansha University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
Approval date
2012-08-08, 1391/05/18
Ethics committee reference number
پ/7/420/19129
Health conditions studied
1
Description of health condition studied
Circumcision
ICD-10 code
Z41.2
ICD-10 code description
Routine and ritual circumcision
Primary outcomes
1
Description
bleeding
Timepoint
One week and one month after surgery
Method of measurement
Surgeon diagnosis
2
Description
Infection
Timepoint
One week and one month after surgery
Method of measurement
Surgeon diagnosis
3
Description
Inflamation
Timepoint
One week and one month after surgery
Method of measurement
Surgeon diagnosis
Secondary outcomes
empty
Intervention groups
1
Description
In circumcision surgery without sutures, the string is not used to repair.
Category
Treatment - Surgery
2
Description
In conventional surgical technique, Absorbable suture to approximate the foreskin and mucosal cuff is used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital of Kermanshah
Full name of responsible person
Ardalan Solimani
Street address
Imam Reza hospital, Parastar Blvd, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kermanshah University of Meical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for research, Kermanshah University of Meical Sciences, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Kermanshah University of Meical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ardalan Solimani
Position
Resident of General Surgery
Other areas of specialty/work
Street address
General Surgery ward, Imam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6311
Fax
Email
ardalansolimani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Omid Amanollahi
Position
Pediatric Surgeon
Other areas of specialty/work
Street address
General Surgery ward, Imam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6312
Fax
Email
oamanolahi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ardalan Solimani
Position
Resident of General Surgery
Other areas of specialty/work
Street address
General Surgery ward, Imam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6311
Fax
Email
ardalansolimani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)