NCT07618884

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2025Sep 2026

Study Start

First participant enrolled

April 15, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 23, 2026

Last Update Submit

May 28, 2026

Conditions

Keywords

Inguinal herniaChronic postoperative inguinal painTrans rectus sheath extra-peritoneal procedure

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate

    Number and percentage of patients with recurrence of hernia after surgery

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Incidence of chronic postoperative inguinal pain

    3 months after surgery

Study Arms (1)

TREPP group

EXPERIMENTAL

Patients undergoing TransREctus Sheath PrePeritoneal Procedure (TREPP) for inguinal hernia repair

Procedure: trans rectus sheath extra-peritoneal procedure (TREPP)

Interventions

The TREPP technique, a minimally invasive open approach utilizing the rectus sheath to access the preperitoneal space

TREPP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with primary unilateral or bilateral inguinal hernia

You may not qualify if:

  • Strangulated hernias.
  • Severe comorbidities precluding surgery ((ASA Class IV,V)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine-Assiut University -Assiut-Egypt

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 38896330BACKGROUND
  • Bokkerink 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.

    PMID: 28219816BACKGROUND
  • Faessen 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.

    PMID: 33400030BACKGROUND
  • Bokkerink 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.

    PMID: 34342299BACKGROUND
  • Eklund 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.

    PMID: 19106673BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Faculty of Medicine-Assiut University

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at General surgery department

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 1, 2026

Study Start

April 15, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations