Inguinal HerniaNCT07618884
TransREctus Sheath PrePeritoneal Procedure (TREPP) for Inguinal Hernia Repair
A study testing trans rectus sheath extra-peritoneal procedure (TREPP) in people with Inguinal Hernia and Inguinal Hernia Repair, run by Assiut University at 1 site in Egypt.
Trial summary
Inguinal hernia repair remains one of the most commonly performed surgical procedures worldwide. Tension-free repair with mesh augmentation is the predominant treatment option, either achieved by preperitoneal laparoscopic hernioplasty or Lichtenstein procedure (LP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Inguinal Hernia Repair
- What is being tested?
- trans rectus sheath extra-peritoneal procedure (TREPP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with primary unilateral or bilateral inguinal hernia
Who cannot join
- Strangulated hernias.
- Severe comorbidities precluding surgery ((ASA Class IV,V)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Faculty of Medicine-Assiut University contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine-Assiut University -Assiut-Egypt
Asyut, Asyut Governorate, 71515
Mohamad Raafat, MD
About this study
Official title: TransREctus Sheath PrePeritoneal Procedure (TREPP) for Inguinal Hernia Repair: A Single-center Prospective Study.
Inguinal hernia repair remains one of the most commonly performed surgical procedures worldwide. Tension-free repair with mesh augmentation is the predominant treatment option, either achieved by preperitoneal laparoscopic hernioplasty or Lichtenstein procedure (LP). As the recurrence rate is reduced to less than 5 % after mesh repair, nowadays, long-term morbidity associated with open inguinal hernia repair is mainly related to chronic postoperative inguinal pain (CPIP). Despite many hypotheses about the possible causes for CPIP, there is now consensus that involvement of inguinal nerves plays a major role.
The trans rectus sheath extra-peritoneal procedure (TREPP) is a minimally invasive open approach utilizing the rectus sheath to access the preperitoneal space. It has shown promise in providing effective repair with potential advantages in cosmesis, postoperative pain, and recurrence rates. It is a medial approach avoiding the interference with the course of all (three) inguinal nerves through lateral abdominal wall.
Read the detailed description
This is a prospective cohort study
- Conditions
- Inguinal Hernia, Inguinal Hernia Repair
- Being tested
- trans rectus sheath extra-peritoneal procedure (TREPP)
- Keywords
- Inguinal hernia, Chronic postoperative inguinal pain, Trans rectus sheath extra-peritoneal procedure
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans rectus sheath extra-peritoneal procedure (TREPP)Procedure or surgery
The TREPP technique, a minimally invasive open approach utilizing the rectus sheath to access the preperitoneal space
| Study group | Role | What they receive |
|---|---|---|
| TREPP group | Experimental | Patients undergoing TransREctus Sheath PrePeritoneal Procedure (TREPP) for inguinal hernia repair Receives: Procedure: trans rectus sheath extra-peritoneal procedure (TREPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Number and percentage of patients with recurrence of hernia after surgery
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Incidence of chronic postoperative inguinal pain
Number and percentage of patients with groin pain that lasts more than three months after inguinal hernia surgery
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Raafat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618884
- Sponsor's protocol ID
- RF-1-6-2025
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faessen JL, Stoot JHMB, Broos PPHL, Vijgen GHEJ, Reisinger KW, Bouvy ND, van Vugt R. Trans rectus sheath extra-peritoneal procedure (TREPP) for inguinal hernia repair under local anesthesia with sedation in the outpatient clinic: a feasibility study. Langenbecks Arch Surg. 2024 Jun 19;409(1):188. doi: 10.1007/s00423-024-03383-z.
PubMed 38896330Bokkerink WJ, Persoon AM, Akkersdijk WL, van Laarhoven CJ, Koning GG. The TREPP as alternative technique for recurrent inguinal hernia after Lichtenstein's repair: A consecutive case series. Int J Surg. 2017 Apr;40:73-77. doi: 10.1016/j.ijsu.2017.02.022. Epub 2017 Feb 20.
PubMed 28219816Faessen JL, Stoot JHMB, van Vugt R. Safety and efficacy in inguinal hernia repair: a retrospective study comparing TREPP, TEP and Lichtenstein (SETTLE). Hernia. 2021 Oct;25(5):1309-1315. doi: 10.1007/s10029-020-02361-w. Epub 2021 Jan 5.
PubMed 33400030Bokkerink WJV, Koning GG, Vriens PWHE, Mollen RMHG, Harker MJR, Noordhof RK, Akkersdijk WL, van Laarhoven CJHM. Open Preperitoneal Inguinal Hernia Repair, TREPP Versus TIPP in a Randomized Clinical Trial. Ann Surg. 2021 Nov 1;274(5):698-704. doi: 10.1097/SLA.0000000000005130.
PubMed 34342299Eklund AS, Montgomery AK, Rasmussen IC, Sandbue RP, Bergkvist LA, Rudberg CR. Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up. Ann Surg. 2009 Jan;249(1):33-8. doi: 10.1097/SLA.0b013e31819255d0.
PubMed 19106673
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransREctus Sheath PrePeritoneal Procedure (TREPP) for Inguinal Hernia Repair: A Single-center Prospective Study.
- ClinicalTrials.gov ID
- NCT07618884
- Acronym / sponsor ID
- RF-1-6-2025
- Conditions
- Inguinal Hernia, Inguinal Hernia Repair
- Keywords
- Inguinal hernia, Chronic postoperative inguinal pain, Trans rectus sheath extra-peritoneal procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Jun 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.
Inguinal hernia repair remains one of the most commonly performed surgical procedures worldwide. Tension-free repair with mesh augmentation is the predominant treatment option, either achieved by preperitoneal laparoscopic hernioplasty or Lichtenstein procedure (LP). As the recurrence rate is reduced to less than 5 % after mesh repair, nowadays, long-term morbidity associated with open inguinal hernia repair is mainly related to chronic postoperative inguinal pain (CPIP). Despite many hypotheses about the possible causes for CPIP, there is now consensus that involvement of inguinal nerves plays a major role.
The trans rectus sheath extra-peritoneal procedure (TREPP) is a minimally invasive open approach utilizing the rectus sheath to access the preperitoneal space. It has shown promise in providing effective repair with potential advantages in cosmesis, postoperative pain, and recurrence rates. It is a medial approach avoiding the interference with the course of all (three) inguinal nerves through lateral abdominal wall.
Detailed description
This is a prospective cohort study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREPP group | Experimental | Procedure: trans rectus sheath extra-peritoneal procedure (TREPP)Patients undergoing TransREctus Sheath PrePeritoneal Procedure (TREPP) for inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with primary unilateral or bilateral inguinal hernia
Key exclusion criteria (2 listed)
- Strangulated hernias.
- Severe comorbidities precluding surgery ((ASA Class IV,V)
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 |
|---|---|---|
| trans rectus sheath extra-peritoneal procedure (TREPP)The TREPP technique, a minimally invasive open approach utilizing the rectus sheath to access the preperitoneal space | Procedure or surgery | TREPP group |
Primary outcome
Recurrence rate
Time frame: through study completion, an average of 1 year
Number and percentage of patients with recurrence of hernia after surgery
1 secondary outcome
Incidence of chronic postoperative inguinal pain
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 38896330Faessen JL, Stoot JHMB, Broos PPHL, Vijgen GHEJ, Reisinger KW, Bouvy ND, van Vugt R. Trans rectus sheath extra-peritoneal procedure (TREPP) for inguinal hernia repair under local anesthesia with sedation in the outpatient clinic: a feasibility study. Langenbecks Arch Surg. 2024 Jun 19;409(1):188. doi: 10.1007/s00423-024-03383-z.
- Background: PubMed 28219816Bokkerink WJ, Persoon AM, Akkersdijk WL, van Laarhoven CJ, Koning GG. The TREPP as alternative technique for recurrent inguinal hernia after Lichtenstein's repair: A consecutive case series. Int J Surg. 2017 Apr;40:73-77. doi: 10.1016/j.ijsu.2017.02.022. Epub 2017 Feb 20.
- Background: PubMed 33400030Faessen JL, Stoot JHMB, van Vugt R. Safety and efficacy in inguinal hernia repair: a retrospective study comparing TREPP, TEP and Lichtenstein (SETTLE). Hernia. 2021 Oct;25(5):1309-1315. doi: 10.1007/s10029-020-02361-w. Epub 2021 Jan 5.
- Background: PubMed 34342299Bokkerink WJV, Koning GG, Vriens PWHE, Mollen RMHG, Harker MJR, Noordhof RK, Akkersdijk WL, van Laarhoven CJHM. Open Preperitoneal Inguinal Hernia Repair, TREPP Versus TIPP in a Randomized Clinical Trial. Ann Surg. 2021 Nov 1;274(5):698-704. doi: 10.1097/SLA.0000000000005130.
- Background: PubMed 19106673Eklund AS, Montgomery AK, Rasmussen IC, Sandbue RP, Bergkvist LA, Rudberg CR. Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up. Ann Surg. 2009 Jan;249(1):33-8. doi: 10.1097/SLA.0b013e31819255d0.
- Individual participant dataSharing planned: No
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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.
Faculty of Medicine-Assiut University contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans rectus sheath extra-peritoneal procedure (TREPP) in people with Inguinal Hernia and Inguinal Hernia Repair, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Jun 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad Raafat, MD (0201067877622, mohamad_raafat10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: through study completion, an average of 1 year). 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 NCT07618884, which also lists 5 linked publications.
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 1 Jun 2026.