Comparison of Lichtenstein Open Hernia Repair with TransAbdominal PrePeritoneal Laparoscopic Repair (both with Spinal Anesthesia) for Early and Late Complications (e.g; Post-operative Pain, Infection, Hematoma, Seroma and Recurrence within the First Year)
Design
Two Arm Parallel Group Randomized Clinical Trial of 84 Patients, Randomization by R Software
Settings and conduct
Eligible patients were randomized into two open and laparoscopic groups.
Hernia repair was done with BARD prolene meshes.
Spinal anesthesia was done with 15mg bupivacaine in both groups.
Laparoscopic group received mild intravenous sedation with 1mg midazolam, 100mg fentanyl and 130mg/h propofol infusion in order to tolerate insufflation.
Post-op pain was evaluated by Visual Analog Scale. Zero score was given for Painlessness and 10 score was given for the worst pain the patient had ever experienced. All patients received 500mg acetaminophen and maximum 3 doses of morphine sulfate and pain evaluation was done before narcotic injection. 48 hours and a week after discharge patients were examined for pain and early post-operative complications.
Recurrence was evaluated in 6 and 12 months by physical examination.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Unilateral Primary Inguinal Hernia in Patients older than 18 Years of Age
Exclusion Criteria: Patient Dissent; Recurrent Hernia; Bilateral Hernia, Patients with Underlying Diseases (e.g; Asthma, Benign prostatic hyperplasia, Chronic obstructive pulmonary disease) and Heavy Workers
Intervention groups
Patients with inguinal hernia will be operated via either of the well-known laparoscopic transabdominal preperitoneal (first group) or open Lichtenstein (second group) methods.
Main outcome variables
Pain; Infection; Hematoma; Seroma; Recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200727048228N1
Registration date:2020-09-05, 1399/06/15
Registration timing:retrospective
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Mansour Nateghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8819 2231
Email address
mansournateghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-25, 1397/06/03
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
2018-08-25, 1397/06/03
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
Comparison of Early Complications and Recurrence in Inguinal Hernia Surgery with Laparoscopic (TAPP) and Open Methods (Lichtenstein)
Public title
Comparison of Inguinal Hernia Repair with Laparoscopic and open Methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of the Patients
Unilateral Non-Incarcerated Primary Inguinal Hernia (Non-Recurrent)
Permuted Block Randomization, Block Size of 2
An 84 row random sequence was produced by R software, then patients who consent to either type of surgery where registered into the aforementioned sequence according to the order of referral and patient's surgery type was determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
As most laparoscopic surgeries are performed under general anesthesia, in order to make both study arms equal, both arms will undergo operation with spinal anesthesia
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Arabi St., Yaman St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-07-10, 1397/04/19
Ethics committee reference number
IR.SBMU.MSP.REC.1397.480
Health conditions studied
1
Description of health condition studied
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
Severity of Post-op Pain
Timepoint
Just After Surgery, 8h, 24h, 48h and a week after the operation
Method of measurement
Visual Analogue Scale
2
Description
Surgical Site Infection
Timepoint
2 and 7 days after surgery
Method of measurement
Physical Examination
3
Description
Seroma
Timepoint
2 and 7 days after surgery
Method of measurement
Physical Examination
4
Description
Hematoma
Timepoint
2 and 7 days after surgery
Method of measurement
Physical Examination
5
Description
Recurrence
Timepoint
6 months and a year after surgery
Method of measurement
Physical Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Trans Abdominal PrePeritoneal Laparoscopic Surgery with Spinal Anesthesia (standard 3 port surgery with transabdominal peritoneal dissection and fixation of mesh in preperitoneal space
Category
Treatment - Surgery
2
Description
Control group: Lichtenstein Open Surgery with Spinal Anesthesia with standard inguinal incision, incising external oblique fascia, skeletonizing cord, resection of hernia sac and fixation of mesh
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Alireza Manafi
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
info@ehmc.ir
Web page address
http://www.ehmc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Yaman St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1000
Email
info@sbmu.ac.ir
Web page address
http://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Chancel of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mansour Nateghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
mansournateghi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behzad Nemati Honar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
behzadnematihonar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mansour Nateghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Hussein Hospital, Madani St, Nezam-Abad
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
mansournateghi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome may be shared
When the data will become available and for how long
Accessible after publication of the trial
To whom data/document is available
Researchers and employees in academic and scientific institutions
Under which criteria data/document could be used
Use of data to complete their studies
From where data/document is obtainable
Dr. Mansour Nateghi
What processes are involved for a request to access data/document
Data can be shared after reviewing the researcher's request and provision of sufficient documentation of his/her research and the reason for using the data