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Comparison of the effect of mesh fixation and non-fixation in laparoscopic transabdominal prepritonal repair (TAPP) of inguinal hernia

Protocol summary

Study aim
Determination and comparison of complications of fixation and non-fixation in laparoscopic transabdominal prepritonal repair (TAPP) of inguinal herni
Design
This study is a clinical trial with control group, Double Blinds, with parallel groups, and Randomization.
Settings and conduct
This was a study on the patients candidated for inguinal hernia repair surgery by laparoscopic method in Isfahan Alzahra Hospital. Samples were 86 patients with inguinal hernia that undergone inguinal hernia repair using mesh by laparoscopic transabdominal prepritonal repair technique. Pain level was measured in patients based on VAS criterion one day after surgery, when releasing the hospital, one and two weeks and one and 6 months after surgery in both groups. In addition, early and late complications including seroma, urinary tract infection, wound infection, mesh infections, urinary retention, and relapse were evaluated in these patients in the first week after surgery and in two weeks, one month, and six months after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of hernia repair surgery, No history of laparotomy ,No strangulated or incarcerated hernia, Were satisfied to participate in the study. Exclusion criteria:Cancellation of the surgery for any reason, Occurrence of unwanted complications during the surgery resulting in serious complications or death, Non-referral of the patient in post-operative follow-up for any reasons ,Dissatisfaction to continue the collaboration in the present study.
Intervention groups
Patients with inguinal hernia requiering surgery undergo inguinal hernia repair using mesh by laparoscopic transabdominal prepritonal repair technique. group1: Mesh was fixed using suture. group2: Mesh was not fixed.
Main outcome variables
Hernia relapse rate, Pain rate, Early and late complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042618N4
Registration date: 2019-04-24, 1398/02/04
Registration timing: retrospective

Last update: 2019-04-24, 1398/02/04
Update count: 0
Registration date
2019-04-24, 1398/02/04
Registrant information
Name
najme bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 8235
Email address
st_bagherin@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-24, 1396/09/03
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2017-12-01, 1396/09/10
Actual recruitment end date
2018-03-01, 1396/12/10
Trial completion date
2018-06-22, 1397/04/01
Scientific title
Comparison of the effect of mesh fixation and non-fixation in laparoscopic transabdominal prepritonal repair (TAPP) of inguinal hernia
Public title
Fixation or non-fixation of mesh in laparoscopic inguinal hernia repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of hernia repair surgery No history of laparotomy No strangulated or incarcerated hernia Were satisfied to participate in the study
Exclusion criteria:
Cancellation of the surgery for any reason Occurrence of unwanted complications during the surgery resulting in serious complications or death Non-referral of the patient in post-operative follow-up for any reasons Dissatisfaction to continue the collaboration in the present study
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 86
Actual sample size reached: 86
Randomization (investigator's opinion)
Randomized
Randomization description
86 eligible patients were recruited to the study by easy non-randomization method. Then we randomly assigned patients to one of tow groups using simple randomization through random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were randomly assigned to one of the two groups before surgery and without themselves knowing their group, their group was recorded by the secretary and the surgeon was informed. After the surgery, the student who was unaware of the allocation of the groups, completed the post-operative pain and other complications and hernia relapse cheklists and delivered to the secretary.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Esfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR.MUI.REC.1396.083

Health conditions studied

1

Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia

Primary outcomes

1

Description
Severity of pain
Timepoint
One day after surgery, when releasing the hospital, one and two weeks and one and 6 months after surgery
Method of measurement
VAS (Visual analogue scale)

2

Description
Early and late complications
Timepoint
The first week after surgery and in two weeks, one month, and six months after surgery.
Method of measurement
Periodic Regular Examination

3

Description
Hernia relapse
Timepoint
The first week after surgery and in two weeks, one month, and six months after surgery.
Method of measurement
Periodic Regular Examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with inguinal hernia undergo inguinal hernia repair using mesh by laparoscopic transabdominal prepritonal repair technique and mesh was fixed using suture.
Category
Treatment - Surgery

2

Description
Intervention group: patients with inguinal hernia undergo inguinal hernia repair using mesh by laparoscopic transabdominal prepritonal repair technique but mesh was not fixed.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital in Isfahan
Full name of responsible person
Zakaria Sherbou
Street address
Alzahra Hospital, Sofe St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1668 5555
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciiences, Hezar jerib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zakaria Sherbou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Building of Prophet Azam, Shahid Reza Pakdel, Isfahan University of Medical Sciences, Hezar Jereb St.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
Dr.zsharbu82@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zakaria Sherbou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Building of Prophet Azam, Shahid Reza Pakdel, Isfahan University of Medical Sciences, Hezar Jereb St.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
dr.zsharbu82@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zakaria Sherbou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Building of Prophet Azam,Shahid Reza Pakdel ,Isfahan University of Medical Sciences, Hezar Jereb St.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
dr.zsharbu82@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data will be kept private.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Useing data to complete studies
From where data/document is obtainable
Isfahan university of medical sience, Dr Zakaria Sherbou
What processes are involved for a request to access data/document
After delibration of researcher request and presentation of adequate documents,it will be able to exhibite
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