A comparative study of classic surgery and non-ligation surgery in pediatric herniotomy in children under 12 years old in Imam Reza hospital of kermanshah.
The objective of this single blind (patients) clinical trial is to compare recurrence and complication rate between two methods of pediatric hernia repair which are repair without sac ligation (intervention) and repair with sac ligation (control). The main inclusion criterion is the children below 12 years old who are candidates for inguinal hernia surgery in Imam Reza hospital of kermanshah. A total of 200 patients are randomly allocated into two groups of intervention (without sac ligation) or control (with sac ligation). The patients who are more susceptible for recurrence (such as: incarcerated hernia, congested hernia, increased intra-abdominal pressure) are excluded from the study. Both group will be evaluated and compared during six month period of time, for recurrence, hematoma and cord inflammation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109257633N1
Registration date:2011-10-27, 1390/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-27, 1390/08/05
Registrant information
Name
Vahid Motamedi
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 918 617 8390
Email address
dr.v.moetamedi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice-chancellor for Research and technology
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 classic surgery and non-ligation surgery in pediatric herniotomy in children under 12 years old in Imam Reza hospital of kermanshah.
Public title
A comparative study of classic surgery and non-ligation surgery in pediatric herniotomy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children below age 12 years who are candidates for inguinal hernia surgery
Exclusion criteria: incarcerated hernia, congested hernia, increased intra abdominal pressure, peritoneal dialysis, ascites and connective tissue disorders
Age
To 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Kermanshah University of Medical Sciences. Research center
Street address
University Reseach Center, No.2 flat, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
00988318384185
Approval date
2011-05-09, 1390/02/19
Ethics committee reference number
پ/7/420/6351
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
unilateral or unspecified inguinal hernia,without obstruction or gangrene
Primary outcomes
1
Description
Recurrence
Timepoint
At the first week, first, third and sixth months
Method of measurement
corresponding to physical examination
Secondary outcomes
1
Description
Hematoma
Timepoint
At the first week, and the first, third and sixth months
Method of measurement
corresponding to physical examination
2
Description
Cord inflammation
Timepoint
A the first week, and the first, third and sixth months
Method of measurement
corresponding to physical examination
Intervention groups
1
Description
Control group: classic surgery (hernial sac ligation)
Category
Treatment - Surgery
2
Description
Intervention group: hernial repair without sac ligation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital of Kermanshah
Full name of responsible person
Vahid moetamedi
Street address
General surgery ward, Imam Reza hospital, Kermanshah
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid najafi
Street address
University reseach center, No.2 flat, 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
Kermanshah University of Medical 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
Vahid Moetamedi
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 1839 4919
Fax
Email
Dr.v.moetamedi@kums.ac.ir
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
University reseach center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1839 4919
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
Vahid Moetamedi
Position
Resident of general surgery
Other areas of specialty/work
Street address
University reseach center, No.2 flat, Shahid Beheshti Blvd, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 1839 4919
Fax
Email
Dr.v.moetamedi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)