Comparison of the Clinical Outcomes of Laparoscopic Inguinal Hernia Surgery using the Preperitoneal Intra-Abdominal TAPP Method with and without Septal Defect Closure in Patients with Inguinal Hernia: A Randomized Controlled Clinical Trial
Comparison of clinical outcomes of laparoscopic inguinal hernia surgery using TAPP preperitoneal intra-abdominal method with and without closure of septal defect
Design
Randomised, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at https://www.sealedenvelope.com, 76 patients who need inguinal hernia surgery will be randomly assigned to two surgery groups: transabdominal preperitoneal method with mesh alone and transabdominal preperitoneal method with Prolene mesh combined with defect internal ring.
Settings and conduct
76 patients who need inguinal hernia surgery will be randomly assigned to two surgery groups: transabdominal preperitoneal method with mesh alone and transabdominal preperitoneal method with prolene mesh combined with internal ring defect surgery. The outcomes of the surgery will be evaluated. In this study, the patients undergoing surgery and the outcome assessor will be unaware of the surgical procedure.
Participants/Inclusion and exclusion criteria
Unilateral or Bilateral Hernia; American Society of Anesthesiologists Risk score (ASA class 1 or 2); No Symptoms of Peritonitis; No Previous Major Abdominal and Pelvic Surgery; No Contraindication General Anesthesia or laparoscopy; No Incarcerated Hernia; No Strangulated Hernia
Intervention groups
Intervention group 1: Transabdominal laparoscopic preperitoneal surgery method without defect closure. Intervention group 2: Transabdominal laparoscopic preperitoneal surgery method with defect closure
Main outcome variables
Occurrence of complications of Hematoma; Operation area infection; Seroma and Pain immediately after surgery;
Returning to normal activities and hernia recurrence after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140310016917N10
Registration date:2024-06-11, 1403/03/22
Registration timing:prospective
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Clinical Outcomes of Laparoscopic Inguinal Hernia Surgery using the Preperitoneal Intra-Abdominal TAPP Method with and without Septal Defect Closure in Patients with Inguinal Hernia: A Randomized Controlled Clinical Trial
Public title
Comparison of the Clinical Outcomes of Laparoscopic Inguinal Hernia Surgery using the Preperitoneal Intra-Abdominal TAPP Method with and without Septal Defect Closure in Patients with Inguinal Hernia: A Randomized Controlled Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral or Bilateral Hernia
American Society of Anesthesiologists Risk score (ASA class 1 or 2)
Exclusion criteria:
Symptoms of Peritonitis
Previous Major Abdominal and Pelvic Surgery
Contraindication General Anesthesia or laparoscopy
Incarcerated Hernia
Strangulated Hernia
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done from the website https://www.sealedenvelope.com. The randomization of this study will be by the blocked randomization method. Based on the list obtained from this website, each person will be randomly assigned to the control or intervention group using 4 random blocks with the number of 19 blocks in a ratio of 1:1. Using this method, each person is assigned one of the letters A or B to each group, and for randomization, the list of codes obtained from this website will be provided to the project researchers, and every patient with inguinal hernia who meets the conditions for entering the study , will be entered into the plan according to the assigned code.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients undergoing surgery will be unaware of which surgical procedure they will undergo, and the outcome assessor will also be unaware of which patient will undergo which procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan university of medical sciences
Street address
University Research and Technology Vice-Chancellor, Shahid Siyadati St., Namjo St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Approval date
2024-04-24, 1403/02/05
Ethics committee reference number
IR.GUMS.REC.1403.018
Health conditions studied
1
Description of health condition studied
Hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Occurrence of complication of Hematoma
Timepoint
24 hours after the surgery
Method of measurement
Clinical examination
2
Description
Occurrence of complication of surgery site infection
Timepoint
One month after surgery
Method of measurement
Clinical examination
3
Description
Occurrence of complication of Seroma
Timepoint
One month to 6 months after surgery
Method of measurement
Clinical examination and ultrasound
4
Description
Acute postoperative pain
Timepoint
24 hours after the surgery
Method of measurement
Visual Analogue Scale
5
Description
Chronic pain after surgery
Timepoint
6 months after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Returning to normal activities
Timepoint
6 months after surgery
Method of measurement
Patient interview
2
Description
Hernia recurrence
Timepoint
6 months after surgery
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Transabdominal laparoscopic preperitoneal surgery method without defect closure
Category
Treatment - Surgery
2
Description
Control group:Transabdominal laparoscopic preperitoneal surgery method with defect closure
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Moein Moghadam Ahmadi
Street address
Poursina Hospital, Parastar St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3232 3970
Email
poursina@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramyar Farzan
Street address
University Research and Technology Vice-Chancellor, Shahid Siyadati St., Namjo St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Moein Moghadam Ahmadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Poursina Hospital, Parastar St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3232 3971
Email
crdu_poursina@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Moein Moghadam Ahmadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Poursina Hospital, Parastar St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3232 3971
Email
crdu_poursina@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Moein Moghadam Ahmadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Poursina Hospital, Parastar St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3232 3971
Email
crdu_poursina@gums.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