Comparison of treatment outcomes of surgical repair in inguinal hernia with classic versus preperitoneal methods on patient satisfaction and reduction of postoperative complications
Usually inguinal herniorrhaphy with mesh is done by two classic and pre-peritoneal methods. Our aim is to compare these two surgery methods in the candidate patients for inguinal herniorrhaphy. Our study community includes candidate patients for inguinal herniorrhaphy with mesh. Inclusion criteria: having hernia, candidate for classic herniorrhaphy, candidate for pre-peritoneal herniorrhaphy, satisfaction to enter to study. Exclusion criteria: diabetes, bleeding disorders, aspirin and corticosteroid consumption. In both groups, the surgeon will incise the skin and subcutaneous tissue of lower part of abdomen and then Scarpa fascia and the roof of inguinal canal. Then, in the first group the floor of canal will be repaired and the mesh will be located on the floor of canal and in the other group, the mesh will be installed under the canal and then the floor will be repaired. Both groups will be compared after surgery according to recurrence, pain, seroma and hematoma in 3 to 12 months periods.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016030826974N1
Registration date:2016-06-07, 1395/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-07, 1395/03/18
Registrant information
Name
Shahab Forutani
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 936 656 6615
Email address
shahabforutani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences
Expected recruitment start date
2015-06-01, 1394/03/11
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment outcomes of surgical repair in inguinal hernia with classic versus preperitoneal methods on patient satisfaction and reduction of postoperative complications
Public title
Comparison treatment outcomes use of two classic and preperitoneal surgery methods in inguinal hernia repair
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having inguinal hernia, candidate for classic herniorrhaphy, candidate for preperitoneal herniorrhaphy, satisfaction to enter to study.
Exclusion criteria: diabetes, bleeding disorders, aspirin and corticosteroid consumption.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Kamalvand street, Khorramabad, Lorestan
City
Khorramabad
Postal code
Approval date
2016-03-08, 1394/12/18
Ethics committee reference number
lums.rec.1394.62
Health conditions studied
1
Description of health condition studied
inguinal herniorrhphy
ICD-10 code
k40
ICD-10 code description
Hernia with both gangrene and obstruction is classified to hernia with gangrene
Primary outcomes
1
Description
pain
Timepoint
Before intervention and two months after intervention
Method of measurement
questionnaire
2
Description
Duration of operation
Timepoint
after intervention
Method of measurement
Clock-Patient case
Secondary outcomes
1
Description
recurrence
Timepoint
3, 4, 5, 6 and 12 months after intervention
Method of measurement
questionnaire
2
Description
hematoma
Timepoint
3, 4, 5 and 6 months after intervention
Method of measurement
questionnaire
3
Description
seroma
Timepoint
3, 4, 5 and 6 months after intervention
Method of measurement
questionnaire
4
Description
patient satisfaction rate
Timepoint
6 months after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group 1: candidate patients for inguinal henniorrhaphy with pre-peritoneal method. In this method, mesh is inserted on the peritoneum layer
Category
Treatment - Surgery
2
Description
Intervention group 2: candidate patients for inguinal henniorrhaphy with classic method. This method is a free tension procedure to repair which employs artificial materials (mesh) to construct the floor of inguinal canal. Mesh is inserted on the anterior surface of Transversalis fascia
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Ashayer hospital
Full name of responsible person
Dr.Hormoz Mahmoudvand
Street address
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Lorestan University of Medical Sciences
Full name of responsible person
Dr.Taheri kalani
Street address
Kamalvand street, Khorramabad, Lorestan
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 of Lorestan University of Medical Sciences