Active — Not RecruitingNot Applicable

Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)

Belgium, France196 participantsStarted 2022-06-30

Plain-language summary

The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient has a primary unilateral or primary bilateral inguinal or femoral hernia eligible for (robot-assisted) laparoscopic TEP or TAPP repair.
✓. Patients with American Society of Anesthesiologists (ASA) grade I to III.
✓. Patient ≥ 18 years of age at study entry.
✓. Patient and investigator signed and dated the informed consent form prior to the index-procedure.

Exclusion criteria

✕. Patient has a recurrent inguinal or femoral hernia.
✕. Patient is treated using the Lichtenstein technique.
✕. Patients with ASA grade IV and V.
✕. Patient is allergic to the components of the 4DMESH®.
✕. Presence of an infected site.
✕. Patient has a life expectancy of less than 5 years.
✕. Patient is unable / unwilling to provide informed consent.
✕. Patient is unable to comply with the protocol or proposed follow-up visits.

What they're measuring

Hernia recurrence

Timeframe: At 12-months follow-up

Trial details

NCT IDNCT05306496

SponsorCousin Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-23

View on ClinicalTrials.gov More Inguinal Hernia trials