Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair

ConditionsInguinal Hernia Unilateral Complications of Surgical Procedures or Medical Care

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorConsorci Sanitari de l'Alt Penedès i Garraf

About this trial

This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with a weak, thin, or divided external oblique aponeurosis.

Ongoing oncological disease

Cirrhotic patients classified as Child B or higher

Women who have previously undergone a cesarean section

Trial design

Design model

Parallel

Treatments tested in this trial

Desarda
Procedure/Surgery
This technique prevent from using a mesh to surgical repair of a inguinal hernia
Lichtenstein
Procedure/Surgery
This technique implies using a mesh to surgical repair of a inguinal hernia

Treatment groups

478 Participants

are divided into 2 treatment groups

Group A: Desarda TechniqueExperimental treatment 1 intervention

Group B: Lichtenstein TechniqueActive comparator 1 intervention

Trial outcomes

Primary outcomes

Rate of Participants with Post-surgery Complications

Any of the following complications: ● Sensation of a foreign body that persists beyond 3 months after surgery, self-reported by the participant ● Seroma within the first 30 days after surgery, verified through physical examination by a surgeon ● Hematoma within the first 30 days after surgery, verified through physical examination by a surgeon ● Infection at the surgical site within the first 30 days after surgery, verified by a surgeon ● Severe postoperative pain (7 or higher on the visual analog scale \[VAS\]) within the first 30 days after surgery, self-reported by the participant ● Chronic postoperative pain (persisting more than three months after surgery), self-reported by the participant ● Persistent loss of skin sensitivity beyond 30 days after surgery, self-reported by the participant ● Limitation of normal activities at home, outside the home, or at work beyond 3 months after surgery, self-reported by the participant

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consorci Sanitari de l'Alt Penedès i Garraf

Lead sponsor

Source ClinicalTrials.gov

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