Comparison of outcomes and complications of mesh fixation and non-fixation in laparoscopic Transabdominal prepritoneal inguinal hernia repair in patients with primary inguinal hernia
Determination and comparison of results and complications of mesh fixation and non-fixation in inguinal hernia surgery by the laparoscopic transperitoneal peritoneal method in patients with primary inguinal hernia
Design
The study will be divided into two groups of fixation and non-fixation. The size of each group will be 56 people. Randomization with random blocks will be done by statistical software. The Phase 4 clinical trial study will be performed on 112 patients.
Settings and conduct
Patients with a primary inguinal hernia who are candidates for surgery by laparoscopic transperitoneal peritoneal will be divided into two groups. The surgical procedure will be different for patients. Patients' postoperative pain information will be collected using the Visual Analog Scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with primary inguinal hernia
Inclusion criteria: age under 18, dementia and other psychological disorders, the impossibility of proper follow-up of the patient, contraindication to general anesthesia, contraindication to laparoscopic surgery, bilateral cases, recurrent cases, previous abdominal surgery history and intra-abdominal adhesion, Drugs abuse, use of neuropsychiatric drugs, liver and kidney diseases
Exclusion criteria: dissatisfaction with continued cooperation, the need to change the surgical procedure to open surgery
Intervention groups
Patients with a diagnosis of primary inguinal hernia who are candidates for laparoscopic transperitoneal peritoneal surgery are included in the study. Surgery will be performed in two groups with mesh fixation and without mesh fixation.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210309050650N2
Registration date:2021-11-06, 1400/08/15
Registration timing:registered_while_recruiting
Last update:2021-11-06, 1400/08/15
Update count:0
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Naser Keikhali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1851
Email address
nkeikhali@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes and complications of mesh fixation and non-fixation in laparoscopic Transabdominal prepritoneal inguinal hernia repair in patients with primary inguinal hernia
Public title
Comparison of mesh fixation and non-fixation in laparoscopic Transabdominal prepritoneal inguinal hernia repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with primary inguinal hernia
Exclusion criteria:
Age under 18 years
Dementia and other psychological disorders
Impossibility of proper follow-up of the patient
Contraindications to general anesthesia
Contraindications Laparoscopic surgery
Bilateral inguinal Hernia
The hernia has recurred
History of previous abdominal surgery and intra-abdominal adhesions
drug abuse
Taking psychiatric drugs
Liver and kidney diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized block is used to randomize the patients under study and to fully observe the randomness of placement in the control group and the sample group because the inclusion process requires randomization due to the ongoing recruitment. Based on the calculated sample size, the sample size in each group is 24 people for easier application of random blocks to randomize the members of each group. Permutations are considered as 6 permutations according to 2 groups: AABB, ABAB, BBAA, BABA, BAAB, ABBA. The permutations are written on 6 cards and the selection of permutations and their order will be randomly selected from among the cards. The order of exit of the cards is written and will determine the order of recruitment of intervention groups based on it. An individual randomization unit will be used for the study. The information of the registered persons will be anonymous and without their personal information.
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 Zanjan University of Medical Sciences
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.ZUMS.REC.1400.343
Health conditions studied
1
Description of health condition studied
Primary inguinal hernia
ICD-10 code
K40.90
ICD-10 code description
Unilateral inguinal hernia, without obstruction or gangrene, not specified as recurrent
Primary outcomes
1
Description
Postoperative pain in patients
Timepoint
Patients' pain will be assessed on days 2, 7 and the third and sixth months after surgery.
Method of measurement
Based on Visual Analogue Scale scale, data would be collected.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the peritoneum is first cut on the middle umbilical ligament so that this incision is 3-4 cm above the hernia defect and extends laterally to the upper anterior iliac spine. After removal and ligation of the sac hernia, the mesh used is usually 10 x 15 so that it can completely cover the myopectineal hole. After fixing the 3D mesh, the mesh will not be fixed. The arched position of the mesh will allow the mesh to fit properly. Finally, the peritoneum is completely closed to prevent the intestines from hitting the mesh.
Category
Treatment - Surgery
2
Description
Control group: In this group, the peritoneum is first cut on the middle umbilical ligament so that this incision is 3-4 cm above the hernia defect and extends laterally to the upper anterior iliac spine. After removal and ligation of the sac hernia, the mesh used is usually 10 x 15 so that it can completely cover the myopectineal hole. After placing the 3D mesh, the mesh will be fixed to the Cooper ligament with the help of a spiral tucker. Finally, the peritoneum is completely closed to prevent the intestines from hitting the mesh. The number of Tackers required to do this will vary in patients.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Naser Keikhali
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
nkeikhali@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Naser Keikhali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
nkeikhali@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Naser Keikhali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
nkeikhali@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Naser Keikhali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
nkeikhali@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available