Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair (HP-tis)

Randomized Controlled Trial Comparing the Desarda Tissue Technique With the Lichtenstein Technique in Primary Inguinal Hernia Repair

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia Unilateral; Complications of Surgical Procedures or Medical Care
• Intervention / Treatment: Procedure: Desarda; Procedure: Lichtenstein

• Study Type: Interventional
• Enrollment (Estimated): 478
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
• Study Contact Backup: Name: Javier Errando, MD; Phone Number: +34938960025; Email: jerrando@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Sant Pere de Ribes, Barcelona, Spain, 08810
      • Recruiting
      • CSAPG
      • Contact: Javier Errando, MD; Phone Number: +34 938960025; Email: jerrando@csapg.cat
      • Contact: Noemi Casaponsa, recerca@csapg.cat; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
      • Principal Investigator: Javier Errando, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desarda Technique; Patients asigned to this arm will be treated with Desarda Technique	Procedure: Desarda; This technique prevent from using a mesh to surgical repair of a inguinal hernia
Active Comparator: Lichtenstein Technique; Patients asigned to this arm will be treated with Lichtenstein Technique	Procedure: Lichtenstein; This technique implies using a mesh to surgical repair of a inguinal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Javier Errando, MD, CSAPG

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Inguinal Hernia; lichtenstein technique; desarda technique
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: CSAPG-65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No