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

Phase 4

Completed

• Conditions: Hernia, Inguinal
• Interventions: Device: Prolene Polypropylene Mesh; Device: Surgisis Inguinal Hernia Matrix

• 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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

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

Arm && Interventions

Group	Intervention	Description
1	Prolene Polypropylene Mesh	The Lichtenstein tension-free hernioplasty with polypropylene mesh
2	Surgisis Inguinal Hernia Matrix	The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0.

Primary Outcome Measures

Name	Time	Method
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	1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

Secondary Outcome Measures

Name	Time	Method
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 rate	1 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