Desarda versus Lichtenstein repair for primary inguinal hernia
Randomized Controlled Trial Comparing the Desarda Tissue Technique With the Lichtenstein Technique in Primary Inguinal Hernia Repair
This study will see if the Desarda (no-mesh) repair or the Lichtenstein (mesh) repair leads to fewer problems after surgery in adults with a primary unilateral inguinal hernia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 478 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 1 site (Sant Pere de Ribes, Barcelona) |
| Trial ID | NCT06650878 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two anterior surgical approaches for primary inguinal hernia repair: the non-mesh Desarda technique and the mesh-based Lichtenstein technique. Eligible adults with primary unilateral inguinal hernia and BMI below 31 who are scheduled for outpatient or elective anterior repair will undergo one of the two procedures at a single center. Participants will be followed for the occurrence of postoperative complications and other relevant outcomes. The trial is conducted at CSAPG in Sant Pere de Ribes, Barcelona, under the sponsorship of the local health consortium.
Who should consider this trial
Good fit: Adults with a primary unilateral inguinal hernia, BMI under 31, suitable for an anterior (open) repair as outpatient or elective admission, and able to give informed consent.
Not a fit: Patients with a weak, thin, or divided external oblique aponeurosis, ongoing oncologic disease, cirrhosis Child B or worse, women with prior cesarean section, or those with cognitive/affective issues limiting cooperation are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the Desarda approach could reduce mesh-related problems and overall postoperative complications compared with the Lichtenstein repair.
How similar studies have performed: Previous series and meta-analyses have reported that Desarda repairs can achieve recurrence rates similar to mesh repairs with potentially less chronic pain, but results are mixed and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with primary inguinal hernia. * Body mass index below 31 * Indication for inguinal hernia repair via anterior approach, either as outpatient surgery (CMA) or elective admission. * Legal capacity to provide informed consent. Exclusion Criteria: * Patients with a weak, thin, or divided external oblique aponeurosis. * Participants diagnosed with any of the following conditions: * Ongoing oncological disease * Cirrhotic patients classified as Child B or higher * Women who have previously undergone a cesarean section * Cognitive or affective conditions that limit the ability to cooperate with the study procedures
Where this trial is running
Sant Pere de Ribes, Barcelona
- Csapg — Sant Pere de Ribes, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Javier Errando, MD — Csapg
- Study coordinator: Javier Errando, MD
- Email: jerrando@csapg.cat
- Phone: +34938960025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.