Inguinal Hernia Repair (Not Urgent)NCT07752524
Comparison of TEP and eTEP Methods in Inguinal Hernia Repair
A study testing TEP Repair and eTEP Repair in people with Inguinal Hernia Repair (Not Urgent), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The enhanced-view totally extraperitoneal (eTEP) technique provides a wider operative field than the conventional totally extraperitoneal (TEP) technique and may facilitate dissection, instrument manipulation, and mesh placement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inguinal Hernia Repair (Not Urgent)
- What is being tested?
- TEP Repair and eTEP Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 19 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Over 18 years of age and patients who agreed to a laparoscopic hernia repair,
- Unilateral inguinal hernia with fascia defect larger than 0.5 cm,
- EHS (European Hernia Society) ( Classification (Primary, lateral or medial, 1, 2 and 3)
- ASA (American Society of Anesthesiologists) 1-3 (not in need of intensive care)
Who cannot join
- Strangulated hernias
- Patients in whom laparoscopic operation is contraindicated,
- Patients who developed recurrence after TEP or eTEP,
- Patients with a history of previous open lower abdominal operation
- Patients who should not receive general anesthesia.
- ASA 3 patients in need of intensive care and ASA 4 patients
- Bilateral hernias.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Ataşehir, 34752
About this study
Official title: Comparative Evaluation of eTEP (Extended View Total Extraperitoneal) and TEP(Total Extraperitoneal) Techniques in Minimally Invasive Inguinal Hernia Repair
The enhanced-view totally extraperitoneal (eTEP) technique provides a wider operative field than the conventional totally extraperitoneal (TEP) technique and may facilitate dissection, instrument manipulation, and mesh placement. This study evaluates the potential advantages of eTEP compared with TEP in laparoscopic inguinal hernia repair.
Read the detailed description
The aim of this study was to compare the laparoscopic totally extraperitoneal (TEP) and enhanced-view totally extraperitoneal (eTEP) techniques for inguinal hernia repair. The two techniques were compared in terms of perioperative parameters, postoperative complications, early recurrence, length of hospital stay, postoperative pain, and quality of postoperative recovery. Quality of recovery was assessed using the Turkish version of the 15-item Quality of Recovery questionnaire (QoR-15T), and the outcomes were statistically compared between the TEP and eTEP groups.
- Conditions
- Inguinal Hernia Repair (Not Urgent)
- Being tested
- TEP Repair, eTEP Repair
- Keywords
- total extraperitoneal repair, inguinal hernia, laparoscopic, extended
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEP RepairProcedure or surgery
Total extraperitoneal repair (TEP)
eTEP RepairProcedure or surgery
extended view total extraperitoneal (eTEP)
| Study group | Role | What they receive |
|---|---|---|
| The TEP group | Active comparator | one of the techniques used Receives: Procedure: TEP Repair |
| The eTEP group | Active comparator | one of the techniques used Receives: Procedure: eTEP Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Ages
Age in years
Measured: 1 week
Patients' Gender
Male or Female
Measured: 1 week
Patients' Weight
Weight in kilograms (kg)
Measured: 1 week
Patients' Height
Height in meters (m)
Measured: 1 week
Patients' BMI
BMI in kg/m²
Measured: 1 week
the number of people with Diabetes Mellitus
determined by numbers of people with Diabetes Mellitus
Measured: 1 week
the number of people with Hypertension
determined by numbers of people with Hypertension
Measured: 1 week
the number of smoker people
determined by numbers of smoker people
Measured: 1 week
Side of operation
Right or Left
Measured: 1 week
the number of people with Direct hernia
determined by numbers of people with Direct hernia
Measured: 1 week
the number of people with Indirect hernia
determined by numbers of people with Indirect hernia
Measured: 1 week
the number of people with Direct+ Indirect hernia
determined by numbers of people with Direct+ Indirect hernia
Measured: 1 week
Defect size
Defect in centimeters (cm)
Measured: 1 week
Diameter of swelling
Diameter of swelling in centimeters2 (cm2)
Measured: 1 week
Number of Tacks
determined by the numbers of tacks used on the patients.
Measured: 1 week
Operation time (min)
Operation time in minutes (min)
Measured: 1 week
Bleeding
Bleeding in milliliters (ml)
Measured: 1 week
Analgesic requirement
1 time or 2 times or 3 times
Measured: 1 week
Duration of hospitalisation
Duration of hospitalisation in days
Measured: 1 week
Return to work time
Return to work time in days
Measured: 1 week
Secondary outcomes (3)
Number of Complications
Determined by medical examinations: Whether there is seroma, haematoma or ecchymosis at 1st- and 3rd-month controls (in terms of number)
Measured: 3 months
Postoperative pain
Postoperative pain was assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. VAS scores were assessed on postoperative day 1 and at postoperative week 1. (in terms of number)
Measured: 1 week
postoperative recovery
Postoperative recovery was assessed using the 15-item Quality of Recovery questionnaire (QoR-15), with a total score ranging from 0 to 150. Higher scores indicate better postoperative recovery, whereas lower scores indicate poorer recovery. The QoR-15 score was assessed at 24 hours postoperatively. (in terms of number)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 May 2023
- Primary completion10 Nov 2023
- Study completion19 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia Repair (Not Urgent)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Prospective Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birol Agca, Assoc. Prof. MD, Study chair, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752524
- Sponsor's protocol ID
- KAEK 2023/102
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I can send an excel file which includes participant data, If the others want IPD via e-mail
Publications
1. Lau WY. History of treatment of groin hernia. World J Surg 2002;26(6): 748-75 2. Arvidsson D et al. Randomised clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia. The British journal of surgery. 2005;92(9):1085-91. 3. Eklund A et al. Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy study g. Chronic pain 5 years after randomised comparison of laparoscopic and Lichtenstein inguinal hernia repair. The British journal of surgery. 2010;97(4):600-8. 4. McCormack K et al (2003). Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database SystRev 5. Leibl BJ et al (2005) Laparoscopic hernia repair-TAPP or/and TEP? LangenbecksArchSurg 390:77-82 6. Mastery of Surgery, 5th Edition, 2011; 2: 1188-926. 69. The enhanced viewTotally extraperitoneal technique for repair of inguinal hernia. SurgEndosc (2012) 26:1187-1189 7. F. Köckerling et al. TEP or TAPP for recurrent inguinal hernia repair register-based comparison of the outcome. SurgEndosc. 2016.p. 3 8. Siddharth Singh et al. A prospective randomised study of eTEP and TEP repair for inguinal hernia in terms of ease of operability, complication and recurrences. AsianJournal of MedicalSciences2022;13(3):87-94 9. Reza SM et al. Early Outcomes of "Extended View Total Extraperitonial (eTEP)" Procedure for Inguinal Hernia. J ShaheedSuhrawardyMedColl 2019; 11(2): 96-100. p. 98 10. Kancham Nethaji et al. Comparison of Extended Total Extraperitoneal (E-TEP) Repair and TransAbdominal Pre-Peritoneal (TAPP) Mesh Repair in Inguinal Hernia Repair. May 2023. Cureus 15(5): e39420. doi:10.7759/cureus.39420 11. Sharma D et al. Prospective randomised trial comparing laparoscopic transabdominal preperitoneal (TAPP) and laparoscopic totally extraperitoneal (TEP) approach for bilateral inguinal hernias, International Journal of Surgery (2015), doi: 10.1016/j.ijsu.2015.07.713 p. 13 12. K. Lawrence et al. Quality of life in patients
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of eTEP (Extended View Total Extraperitoneal) and TEP(Total Extraperitoneal) Techniques in Minimally Invasive Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT07752524
- Acronym / sponsor ID
- KAEK 2023/102
- Conditions
- Inguinal Hernia Repair (Not Urgent)
- Keywords
- total extraperitoneal repair, inguinal hernia, laparoscopic, extended
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The enhanced-view totally extraperitoneal (eTEP) technique provides a wider operative field than the conventional totally extraperitoneal (TEP) technique and may facilitate dissection, instrument manipulation, and mesh placement. This study evaluates the potential advantages of eTEP compared with TEP in laparoscopic inguinal hernia repair.
Detailed description
The aim of this study was to compare the laparoscopic totally extraperitoneal (TEP) and enhanced-view totally extraperitoneal (eTEP) techniques for inguinal hernia repair. The two techniques were compared in terms of perioperative parameters, postoperative complications, early recurrence, length of hospital stay, postoperative pain, and quality of postoperative recovery. Quality of recovery was assessed using the Turkish version of the 15-item Quality of Recovery questionnaire (QoR-15T), and the outcomes were statistically compared between the TEP and eTEP groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Prospective Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| The TEP group | Active comparator | Procedure: TEP Repairone of the techniques used |
| The eTEP group | Active comparator | Procedure: eTEP Repairone of the techniques used |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age and patients who agreed to a laparoscopic hernia repair,
- Unilateral inguinal hernia with fascia defect larger than 0.5 cm,
- EHS (European Hernia Society) ( Classification (Primary, lateral or medial, 1, 2 and 3)
- ASA (American Society of Anesthesiologists) 1-3 (not in need of intensive care)
Key exclusion criteria (7 listed)
- Strangulated hernias
- Patients in whom laparoscopic operation is contraindicated,
- Patients who developed recurrence after TEP or eTEP,
- Patients with a history of previous open lower abdominal operation
- Patients who should not receive general anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEP RepairTotal extraperitoneal repair (TEP) | Procedure or surgery | The TEP group |
| eTEP Repairextended view total extraperitoneal (eTEP) | Procedure or surgery | The eTEP group |
Primary outcome
Patients' Ages
Time frame: 1 week
Age in years
Patients' Gender
Time frame: 1 week
Male or Female
Patients' Weight
Time frame: 1 week
Weight in kilograms (kg)
Patients' Height
Time frame: 1 week
Height in meters (m)
Patients' BMI
Time frame: 1 week
BMI in kg/m²
the number of people with Diabetes Mellitus
Time frame: 1 week
determined by numbers of people with Diabetes Mellitus
the number of people with Hypertension
Time frame: 1 week
determined by numbers of people with Hypertension
the number of smoker people
Time frame: 1 week
determined by numbers of smoker people
Side of operation
Time frame: 1 week
Right or Left
the number of people with Direct hernia
Time frame: 1 week
determined by numbers of people with Direct hernia
the number of people with Indirect hernia
Time frame: 1 week
determined by numbers of people with Indirect hernia
the number of people with Direct+ Indirect hernia
Time frame: 1 week
determined by numbers of people with Direct+ Indirect hernia
Defect size
Time frame: 1 week
Defect in centimeters (cm)
Diameter of swelling
Time frame: 1 week
Diameter of swelling in centimeters2 (cm2)
Number of Tacks
Time frame: 1 week
determined by the numbers of tacks used on the patients.
Operation time (min)
Time frame: 1 week
Operation time in minutes (min)
Bleeding
Time frame: 1 week
Bleeding in milliliters (ml)
Analgesic requirement
Time frame: 1 week
1 time or 2 times or 3 times
Duration of hospitalisation
Time frame: 1 week
Duration of hospitalisation in days
Return to work time
Time frame: 1 week
Return to work time in days
3 secondary outcomes
Number of Complications
Time frame: 3 months
Postoperative pain
Time frame: 1 week
postoperative recovery
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background1. Lau WY. History of treatment of groin hernia. World J Surg 2002;26(6): 748-75 2. Arvidsson D et al. Randomised clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia. The British journal of surgery. 2005;92(9):1085-91. 3. Eklund A et al. Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy study g. Chronic pain 5 years after randomised comparison of laparoscopic and Lichtenstein inguinal hernia repair. The British journal of surgery. 2010;97(4):600-8. 4. McCormack K et al (2003). Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database SystRev 5. Leibl BJ et al (2005) Laparoscopic hernia repair-TAPP or/and TEP? LangenbecksArchSurg 390:77-82 6. Mastery of Surgery, 5th Edition, 2011; 2: 1188-926. 69. The enhanced viewTotally extraperitoneal technique for repair of inguinal hernia. SurgEndosc (2012) 26:1187-1189 7. F. Köckerling et al. TEP or TAPP for recurrent inguinal hernia repair register-based comparison of the outcome. SurgEndosc. 2016.p. 3 8. Siddharth Singh et al. A prospective randomised study of eTEP and TEP repair for inguinal hernia in terms of ease of operability, complication and recurrences. AsianJournal of MedicalSciences2022;13(3):87-94 9. Reza SM et al. Early Outcomes of "Extended View Total Extraperitonial (eTEP)" Procedure for Inguinal Hernia. J ShaheedSuhrawardyMedColl 2019; 11(2): 96-100. p. 98 10. Kancham Nethaji et al. Comparison of Extended Total Extraperitoneal (E-TEP) Repair and TransAbdominal Pre-Peritoneal (TAPP) Mesh Repair in Inguinal Hernia Repair. May 2023. Cureus 15(5): e39420. doi:10.7759/cureus.39420 11. Sharma D et al. Prospective randomised trial comparing laparoscopic transabdominal preperitoneal (TAPP) and laparoscopic totally extraperitoneal (TEP) approach for bilateral inguinal hernias, International Journal of Surgery (2015), doi: 10.1016/j.ijsu.2015.07.713 p. 13 12. K. Lawrence et al. Quality of life in patients
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. I can send an excel file which includes participant data, If the others want IPD via e-mail
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birol Agca, Assoc. Prof. MD study chair
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEP Repair and eTEP Repair in people with Inguinal Hernia Repair (Not Urgent), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Ages (time frame: 1 week). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07752524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.