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

Phase 4
Completed
Conditions
Hernia, Inguinal
Registration Number
NCT00614419
Lead Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
70
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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 groups1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
Secondary Outcome Measures
NameTimeMethod
to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
to rate the wound infection risk.1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
to measure the recurrence rate1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).3, 6 months, 1, 2, 3, 4, 5 years

Trial Locations

Locations (1)

St.Orsola-Malpighi University Hospital

🇮🇹

Bologna, Italy

St.Orsola-Malpighi University Hospital
🇮🇹Bologna, Italy
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