The outcomes of enhanced view of total extraperitoneal inguinal (e-TEP) hernia repair are better than Trans abdominal preperitoneal (TAPP) hernia repairs.
The objective of this study is to compare the differences in postoperative complication, surgical procedure length, duration of hospitalization, duration of return to work and relapse frequency between the enhanced view totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) approaches for inguinal hernia repairs.
Design
Randomized control trial, non blinded, with parallel group design of 50 patient for suspected period of 6 months after approval of RCT.
Settings and conduct
This study was conducted in Sheikh Zayed Hospital Rahim Yar khan. The study was not blinded. The patient were told about the surgery. The surgery was done after informed written consent.
Participants/Inclusion and exclusion criteria
Patient with age 15 and 60 year of any gender were included. Patient with reducible inguinal hernia were included. Patient having previous history of mildline surgery and with recurrent inguinal hernia were excluded. Patient with strangulated and obstructed hernia were excluded.
Intervention groups
Two groups wer made. In one group A patients were undergone trans abdominal preperitoneal hernia repair (TAPP) and in group B total extraperitoneal hernia repair (e-TEP) was done after informed written consent.
Main outcome variables
Postoperative complication, Surgical procedure length, Duration of hospitalization, Duration of return to work and relapse frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240503061640N2
Registration date:2024-09-22, 1403/07/01
Registration timing:prospective
Last update:2024-09-22, 1403/07/01
Update count:0
Registration date
2024-09-22, 1403/07/01
Registrant information
Name
Muhammad Ahsan Mustafa
Name of organization / entity
CPSP
Country
Pakistan
Phone
+92 333 3396180
Email address
whereisdrahsan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-01, 1403/07/10
Expected recruitment end date
2025-10-01, 1404/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The outcomes of enhanced view of total extraperitoneal inguinal (e-TEP) hernia repair are better than Trans abdominal preperitoneal (TAPP) hernia repairs.
Public title
The outcomes of enhanced view of total extraperitoneal inguinal (e-TEP) hernia repair are better than Trans abdominal preperitoneal (TAPP) hernia repairs.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient included with age between 15 and 60 years
Patient with inguinal hernia were added
Patient with reducible inguinal hernia were included
Patient of age gender were included
Patient having no previous history of surgery were included
Exclusion criteria:
Patient below age 15 and above age 60 were excluded
Irreducible inguinal hernia were excluded
Obstructed and strangulated inguinal hernia were excluded
Patient with recurrent inguinal hernia were excluded
Patient with previous midline scar were excluded
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
I used computer generated software SPSS version 23 for randomization. First the sample size was randomized into two groups by using SPSS. Then subjects were assign to each group accordingly.
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
Institutional review board Sheikh Zayed Medical College/Hospital Rahim yar khan.
Street address
C899+333, Rahim Yar Khan, Punjab
City
Rahim Yar Kahn
Postal code
64200
Approval date
2023-08-03, 1402/05/12
Ethics committee reference number
750/IRB/SZMC/SZH
Health conditions studied
1
Description of health condition studied
Inguinal Hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Post operative pain, bleeding/seroma, return to daily work, hospital stay.
Timepoint
Post operative period and follow up (6 week)
Method of measurement
By clinical examination and ultrasonography.
Secondary outcomes
1
Description
Recurrence of hernia and re admission rate.
Timepoint
After surgery till 1 year
Method of measurement
Clinical examination and ultrasonography.
Intervention groups
1
Description
Intervention group 1: underwent TAPP surgery for hernia repair.
Category
Treatment - Surgery
2
Description
Intervention group 2: underwent e-TEP surgery for hernia repair
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh Zayed Medical College/Hospital Rahim Yar Khan.
Full name of responsible person
Khurram Niaz
Street address
C899+333, Rahim Yar Khan, Punjab
City
Rahim Yar Khan
Postal code
64200
Phone
+92 321 6801550
Email
Khurram.niaz@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sheikh zayed medical college
Full name of responsible person
Prof Tariq ghafoor .Director department of medical education
Street address
Sheikh zayed medical college
City
Rahim Yar Khan
Postal code
66000
Phone
+92 300 6748909
Email
Tariqghafoor55@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sheikh zayed medical college
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
Sheikh Zayed Medical College/Hospital Rahim Yar Kahn
Full name of responsible person
Dr Khurram Niaz
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
C899+333, Rahim Yar Khan, Punjab
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 321 6801550
Email
Khurram.niaz@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sheikh Zayed Medical College/Hospital Rahim Yar Kahn
Full name of responsible person
Khurram Niaz
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
C899+333, Rahim Yar Khan, Punjab
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 321 6801550
Email
Khurram.niaz@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Bahawalpur
Full name of responsible person
Muhammad Ahsan Mustafa
Position
Resident surguery
Latest degree
Bachelor
Other areas of specialty/work
General Surgery
Street address
Near Noor Mahal
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 333 3396180
Email
whereisdrahsan@yahoo.com
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The outcomes of enhanced view of total extraperitoneal inguinal (e-TEP) hernia repair are better than Trans abdominal preperitoneal (TAPP) hernia repairs.
When the data will become available and for how long
In July 2026
To whom data/document is available
Only available for the people working in academic institutions
Under which criteria data/document could be used
whereisdrahsan@yahoo.com
From where data/document is obtainable
whereisdrahsan@yahoo.com
What processes are involved for a request to access data/document