Desarda Tissue Technique Vs Lichtenstein Technique for Primary Inguinal Hernia Repair

Not Applicable

Not yet recruiting

• Conditions: Inguinal Hernia Unilateral; Complications of Surgical Procedures or Medical Care

• Registration Number: NCT06650878
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Study Start: 2025-03-01
• Primary Completion: 2027-12-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 478

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Participants with Post-surgery Complications	3 months	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

Trial Locations

Locations (1)

CSAPG; 🇪🇸 Sant Pere de Ribes, Barcelona, Spain