Comparative study of the effect of fixation mesh and non-fixation of mesh (Use of external fixation (hernia band) after surgery) in causing postoperative complications in patients with inguinal hernia undergoing laparoscopic hernioplasty
Determining and comparing the effect of internal mesh fixation and non-mesh fixation (using external fixation) in causing complications after hernioplasty surgery
Design
Randomized, Single-blinding clinical trial, with the parallel groups, Phase 3 on 64 patients
Settings and conduct
In this randomized, single-blind randomized clinical trial study, 64 patients with inguinal hernia referred to Al-Zahra Hospital in Isfahan will be included in the study and randomly divided into 2 groups. Laparoscopic surgery is used in both groups. In one group the mesh is fixed for patients and in the other group the mesh is not fixed internally and the patient uses a hernia band after surgery. Patients' complications will then be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include having an inguinal hernia and consent to participate in the study. Exclusion criteria include having one of the incarcerated, strangulated, very large (scrotal) or femoral inguinal hernias.
Intervention groups
Control group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh is fixed internally (using suture or tack).
Intervention group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh is not fixed and after the operation, an external hernia is used.
Main outcome variables
Seroma incidence; Hematoma incidence; Recurrence of hernia; Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N25
Registration date:2021-03-17, 1399/12/27
Registration timing:registered_while_recruiting
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-07, 1399/11/19
Expected recruitment end date
2021-04-18, 1400/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of fixation mesh and non-fixation of mesh (Use of external fixation (hernia band) after surgery) in causing postoperative complications in patients with inguinal hernia undergoing laparoscopic hernioplasty
Public title
Comparison of the effect of fix and non-fix mesh (Use of external fixation (hernia band) after surgery) in causing complications after hernioplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an inguinal hernia
Satisfaction with participation in this study
Exclusion criteria:
Having an incarcerated hernia
Having a strangulated hernia
Having a very large inguinal hernia (scrotal)
Having a femoral inguinal hernia
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 64 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the present study, the surgeon is aware of the type of surgery in each of the two groups, but the patient and the evaluator (data collector) are not aware of the type of surgery in each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.MUI.MED.REC.1399.825
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40.3
ICD-10 code description
Unilateral inguinal hernia, with obstruction, without gangrene
Primary outcomes
1
Description
Seroma
Timepoint
1, 3 and 6 months after surgery
Method of measurement
Observation
2
Description
Hematoma
Timepoint
1, 3 and 6 months after surgery
Method of measurement
Observation
3
Description
Pain
Timepoint
1, 3 and 6 months after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Recurrence of hernia
Timepoint
1, 3 and 6 months after surgery
Method of measurement
Observation
Intervention groups
1
Description
Control group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh(Bard 3D Max) is fixed internally (using Vicryl suture 2-0).
Category
Treatment - Surgery
2
Description
Intervention group: Patients in this group are treated for inguinal hernia repair by laparoscopic method and for these patients the mesh is not fixed and after the operation, an external hernia(Paksaman) is used.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Masoud Sayadi Shahraki
Street address
Department of Surgery, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sayadi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Masoud Sayadi Shahraki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Hospital, Department of Surgery
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sayadi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi Shahraki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Hospital, Department of Surgery
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sayadi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zakaria Sharbu
Position
Non-faculty specialist physician
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Hospital, Department of Surgery
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
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