Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair

NCT06650878 | Recruiting

• 1 other identifier: CSAPG-65
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia Unilateral; Complications of Surgical Procedures or Medical Care

Keywords

Inguinal Hernia; lichtenstein technique; desarda technique

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (2)

Desarda Technique

EXPERIMENTAL

Patients asigned to this arm will be treated with Desarda Technique

Procedure: Desarda

Lichtenstein Technique

ACTIVE COMPARATOR

Patients asigned to this arm will be treated with Lichtenstein Technique

Procedure: Lichtenstein

Interventions

Desarda PROCEDURE

This technique prevent from using a mesh to surgical repair of a inguinal hernia

Desarda Technique

Lichtenstein PROCEDURE

This technique implies using a mesh to surgical repair of a inguinal hernia

Lichtenstein Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

CSAPG

Sant Pere de Ribes, Barcelona, 08810, Spain

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Errando, MD

  CSAPG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Errando, MD

CONTACT

+34938960025; jerrando@csapg.cat

Noemi Casaponsa

CONTACT

+34 938960025; recerca@csapg.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: March 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (1)