A Comparative Evaluation of Mesh Fixation versus Non-Fixation in Patients Undergoing Transabdominal Preperitoneal (TAPP) Hernia Repair at Sina Hospital (2023–2025)
Design
Patients were randomly allocated into two groups by the study consultant. They subsequently underwent laparoscopic hernia repair using either mesh fixation or non-fixation. Each group consisted of 42 patients.
Settings and conduct
Patients aged 18–70 years who presented to Sina Teaching Hospital were included in the study. Data were collected from patients’ clinical records as well as through the use of a checklist during in-person follow-up visits at 2 weeks, 1 month, 3 months, and 1 year after surgery.
Participants/Inclusion and exclusion criteria
Patients aged 18–70 years with a primary diagnosis of inguinal hernia confirmed by preoperative ultrasonography and/or physical examination, with no history of cardiac disease and no previous hernia surgery.
Intervention groups
Patients were randomly assigned to one of two treatment groups using block randomization. Random allocation was performed using blocks of varying sizes, all of which were multiples of two. Initially, block sizes were randomly selected, and subsequently, one of the possible permutations ensuring equal group sizes was generated.
After allocation, patients were assigned to Group A or Group B. Group A included patients who underwent TAPP hernia repair with mesh fixation, while Group B consisted of patients who underwent TAPP hernia repair without mesh fixation.
Main outcome variables
In laparoscopic TAPP hernia repair, proper use of mesh without fixation may reduce the risk of recurrence, as well as decrease patient-related costs and the time required to return to normal activities.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241011063328N1
Registration date:2026-02-04, 1404/11/15
Registration timing:retrospective
Last update:2026-02-04, 1404/11/15
Update count:0
Registration date
2026-02-04, 1404/11/15
Registrant information
Name
ghazal noorani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4494 1931
Email address
ghazalnourani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-12-06, 1404/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of Mesh Fixation versus Non-Fixation in Patients Undergoing TAPP Hernia Repair
Public title
A Comparative Study of Mesh Fixation versus Non-Fixation in Patients Undergoing TAPP Hernia Repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of inguinal hernia
Absence of heart disease
No history of hernia surgery
Exclusion criteria:
Patients with a history of diabetes
Patients with chronic infections
Patients with heart problems
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated into two groups: mesh fixation and non-fixation. Randomization was performed by the study consultant surgeon, who was not involved in data collection or outcome assessment. The investigators were blinded to group allocation.
Following the reviewer’s comment, to address this concern, patient allocation was conducted by an independent surgeon (the study consultant), as previously stated.
Blinding (investigator's opinion)
Not 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 Tehran University of Medical Sciences
Street address
Qods ave, Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-10-07, 1403/07/16
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1403.089
Health conditions studied
1
Description of health condition studied
Inguinal Hernia
ICD-10 code
K40
ICD-10 code description
An abdominal hernia with an external bulge in the groin region
Primary outcomes
1
Description
Recurrence
Timepoint
Two weeks, one month, three months and one year
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: with mesh fixation
Category
Treatment - Devices
2
Description
Control group: No fixation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
M taghi Talebian
Street address
Hasan abad sq,Tehran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
M taghi Talebian
Street address
Qods ave, keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ghazal Noorani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Laleh ave, Ferdows Blvd , Tehran
City
Tehran
Province
Tehran
Postal code
1484933941
Phone
+98 21 4494 1931
Email
ghazalnourani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazal Noorani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Laleh ave, Ferdows Blvd , Tehran
City
Tehran
Province
Tehran
Postal code
1484933941
Phone
+98 21 4494 1931
Email
ghazalnourani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazal Noorani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 22,South Laleh,Hejazi Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1484933941
Phone
+98 21 4494 1931
Fax
Email
ghazalnourani@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