The effect of not opening the external oblique fascia on surgical complications in comparison with surgical method with opening the external oblique fascia in pediatric inguinal hernia surgery
The purpose of this study was the investigation into the effect of not opening the external oblique fascia on surgical complications in comparison with surgical method with opening the external oblique fascia in pediatric inguinal hernia surgery. A group of 50 children with inguinal hernia will be considered and randomly divided in two groups each with 25 people and one of the groups will undergo surgery with opening external oblique fascia and other group without opening the external oblique fascia. All the patients will have a short follow-up during surgery and after surgery and the first day after surgery and the first week after surgery for early complication and also a long-term follow-up during the first and six months after surgery for long-term complications.The results will be analyzed by statistical methods. The inclusion criteria: age under 4 years, presence at specified times to be followed-up, and no hernia complication before surgery. Exclusion criteria: age over 4 years, hernia complication before surgery, absence at specified times to be followed-up. The main outcome variable is fewer complications after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012016279N1
Registration date:2015-05-02, 1394/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-02, 1394/02/12
Registrant information
Name
Hormoz Mahmoudvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1322 3004
Email address
dr.mahmoudvand@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Khorramabad
Expected recruitment start date
2014-01-30, 1392/11/10
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of not opening the external oblique fascia on surgical complications in comparison with surgical method with opening the external oblique fascia in pediatric inguinal hernia surgery
Public title
The effect of surgical methods on pediatric groin hernia surgery complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age under 4 years, be present at specified times to track, not complicated before hernia surgery
Exclusion criteria: age over 4 years, before surgery the hernia were complicated, were not present at specified times to track
Age
To 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study persons were divided in two groups via simple random sampling with using a random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Lorestan University of Medical Sciences
Street address
Research and Technology University
City
khorramabad
Postal code
Approval date
2012-12-22, 1391/10/02
Ethics committee reference number
200/79123
Health conditions studied
1
Description of health condition studied
inguinal hernia in infant
ICD-10 code
K40,K40.0,
ICD-10 code description
Inguinal hernia, Bilateral inguinal hernia, with obstruction, without gangrene, Bilateral inguinal hernia, with gangrene, Bilateral inguinal hernia, without obstruction or gangrene, Unilateral or unspecified inguinal hernia, with obstruction, without gang
Primary outcomes
1
Description
Complications of surgery
Timepoint
During the surgery, immediately after surgery, one day after the surgery, a week after surgery, one month after surgery, six months after surgery
Method of measurement
Physical examination and observation by physician
Secondary outcomes
1
Description
Surgical incision size
Timepoint
During surgery
Method of measurement
Ruler
2
Description
Surgical duration
Timepoint
From the beginning to the end of the surgery
Method of measurement
Stopwatch
3
Description
Relapse after surgery
Timepoint
A week after surgery, one month after surgery, six months after surgery
Method of measurement
Physical examination and observation by physician
Intervention groups
1
Description
Intervention1 (intervention group) : surgery without opening the external oblique fascia, in this surgical procedure the tissues are damaged less since the external oblique fascia is not be entered
Category
Treatment - Surgery
2
Description
Intervention2 (control group) : Surgery with opening the external oblique fascia
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Ashayer Hospital
Full name of responsible person
Hormoz Mahmoudvand
Street address
Department of Surgery, Revolution Street, Shohada Ashayer Hospital, Khorramabad
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Kaedi
Street address
Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Khorramabad
City
Khorramabad
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 and Technology, Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Hormoz Mahmoudvand
Position
Surgeon
Other areas of specialty/work
Street address
Department of Surgery, Revolution Street, Shohada ashayer hospital, Khorramabad
City
Khorramabad
Postal code
Phone
+98 663323004
Fax
Email
dr.mahmoudvand@lums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Hormoz Mahmoudvand
Position
Surgeon
Other areas of specialty/work
Street address
Department of Surgery,Revolution Street, Shohada Ashayer Hospital, Khorramabad
City
Khorramabad
Postal code
Phone
+98 66 1322 3004
Fax
Email
dr.mahmoudvand@lums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Education
Full name of responsible person
Elham Sheikh
Position
MSc of Educational Administration
Other areas of specialty/work
Street address
Clinical Research Unit, Department of Education, Shohada Ashayer Hospital, Khorramabad
City
Khorramabad
Postal code
Phone
+98 66 1322 3004
Fax
Email
nedaesh1@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)