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The Enhanced View-Totally Extra-peritoneal (eTEP) Technique for Repair of Inguinal Hernia after Radical Prostatectomy: A Clinical Trial

Protocol summary

Study aim
Evaluation of the outcomes of the Enhanced View-Totally Extra-peritoneal (eTEP) technique for repair of inguinal hernia after radical prostatectomy
Design
A controlled clinical trial with paralleled groups of intervention (eTEP) and control (TAPP), without blinding, non-randomized, phase 3, with a sample size of 15 in each group.
Settings and conduct
This Phase 3 clinical trial evaluates patients by a general surgeon (laparoscopic fellowship) who reviews their history and examines them. If an inguinal hernia is diagnosed after radical prostatectomy, its type and suitability for extended total extraperitoneal surgery are assessed. Eligible patients are enrolled. An equal number in the other group undergo transabdominal preperitoneal surgery. Patients are selected and categorized through census sampling, not randomly. The sample size is 15 per group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inguinal hernia diagnosis, Informed written consent, eligibility for laparoscopic surgery, absence of contra-indication for laparoscopic surgery, Exclusion criteria: hematologic and severe comorbidities, psychological and cognitive disorders, and generalized infectious disease
Intervention groups
The intervention groups will be operated with the eTEP technique, and the control group will be operated with the Transabdominal Preperitoneal (TAPP) technique.
Main outcome variables
Patients will undergo an ultrasound examination the day after surgery to identify any hematomas, seromas, or potential mesh displacements. Pain levels will be assessed using the Visual Analog Scale (VAS). Follow-up will be conducted via a questionnaire, either in-person if necessary or otherwise by phone. The following outcomes will be evaluated: Pain severity, surgery complications, vascular injury, bladder injury, intestine injury, and duration to regain pre-surgical daily abilities.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231029059895N1
Registration date: 2025-03-14, 1403/12/24
Registration timing: registered_while_recruiting

Last update: 2025-03-14, 1403/12/24
Update count: 0
Registration date
2025-03-14, 1403/12/24
Registrant information
Name
Masoud Sayadishahraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 184 8098
Email address
drsayadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-04, 1403/10/15
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Enhanced View-Totally Extra-peritoneal (eTEP) Technique for Repair of Inguinal Hernia after Radical Prostatectomy: A Clinical Trial
Public title
The Enhanced View-Totally Extra-peritoneal (eTEP) Technique for Repair of Inguinal Hernia after Radical Prostatectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inguinal Hernia diagnosis with a history of radical prostatectomy
Exclusion criteria:
Patients eligibility to be laparscopic inguinal hernia repair surgery candidates.
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib St., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2025-02-08, 1403/11/20
Ethics committee reference number
IR.MUI.MED.REC.1403.455

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
Grade of pain
Timepoint
2 hours, 1 day, at discharge, one month after surgery
Method of measurement
Visual Analogue Scale

2

Description
complications (Hematoma, seroma, Rehospitalization, Hernia recurrence), Vascular, bladder or, bowels injury
Timepoint
During or after surgery
Method of measurement
Surgeon's evaluations and reports

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patients in this group are operated with the eTEP technique, which is described as follows: A transverse incision is performed superior to the umbilicus, utilizing a transrectal approach on the left side. The posterior sheath of the rectus abdominis muscle is meticulously separated to gain access to the preperitoneal space. The carbon dioxide gas source is calibrated to achieve an intra-abdominal pressure (IAP) of 12 mmHg. Following this, a 10 mm optic trocar is introduced. The hernia sac is transferred into the preperitoneal space and repositioned laterally. The pubic bone and the inguinal ligament are subsequently isolated. A 12 × 15 cm mesh is secured in place using a stapler. The preperitoneal space is then evacuated, and the surgical wounds are sutured closed, followed by bandaging.
Category
Treatment - Surgery

2

Description
Control group: Patients in this group are operated on with the TAPP technique. In Transabdominal Preperitoneal (TAPP) repair for inguinal hernia, the procedure begins with the patient under general anesthesia in a supine Trendelenburg position. A 10 mm infraumbilical trocar is inserted for the laparoscope, with two additional 5 mm working ports placed in the lower abdomen. A peritoneal incision is made above the hernia defect, and the peritoneal flap is dissected to expose the preperitoneal space. The hernia sac is carefully reduced, with indirect sacs fully dissected and direct sacs reduced. A synthetic mesh (typically 10x15 cm) is then placed in the preperitoneal space, covering the myopectineal orifice, and secured with tacks or fibrin glue if necessary. The peritoneal flap is closed using sutures or tacks to prevent mesh exposure to the bowel. Finally, trocar sites are closed, and the patient is awakened from anesthesia and monitored postoperatively for early complications.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Masoud Sayyadi
Street address
Sofe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/

2

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Masoud Sayyadi
Street address
Kashani St.
City
Isfahan
Province
Isfehan
Postal code
kashani@mui.ac.ir
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayyad Shahraki
Street address
Sofe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
drsayadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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 Sayyadi Shahraki
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Sofe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
drsayadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Jalili
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sofe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
jalili.alireza110@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Jalili
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sofe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
jalili.alireza110@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
No more information is available.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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