Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis

Hernia, Inguinal Clinical Trial

Official title: Prospective Randomized, Double-blind, Controlled Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis ES Soft Tissue Graft

Status Completed

Clinical Trial Summary

To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.

Clinical Trial Description

Inclusion and Exclusion Criteria

Inclusion criteria:

• Male, adult patients

• ASA I-III patients

• Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh

• Informed consent

Exclusion criteria

• Recurrent hernias

• Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)

• Hypersensitivity to any drug in study

• Patients with an intra-operative findings of different pathology will be excluded from the study

Outcomes:

General objectives of the study will be:

1. to determine the safety of the Lichtenstein's hernioplasty with Surgisis ES by noting any complications observed intraoperatively and postoperatively

2. to determine the efficacy of the Lichtenstein's hernioplasty with Surgisis ES in comparison with the traditional method with polypropylene mesh by noting the grade of postoperative pain, discomfort, quality of life, the rate of wound infection and other complications, and the recurrence rate.

The specific objectives of the study will be:

1. to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups.

2. to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).

3. to measure the postoperative health general status and quality of life with the Short Form 36 (SF-36) questionnaire.

4. to rate the wound infection risk.

5. to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.

6. to measure the recurrence rate. ;

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

• NCT number: NCT00614419
• Study type: Interventional
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Status: Completed
• Phase: Phase 4
• Start date: January 2003
• Completion date: December 2003