Clinical trial NCT00614419: Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis
Official title: Prospective Randomized, Double-blind, Controlled Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis ES Soft Tissue Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia, Inguinal
Keywords: Hernioplasty
polypropylene
extracellular matrix
xenograft
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
Secondary outcomes:
measure: to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
timeFrame: 3, 6 months, 1, 2, 3, 4, 5 years
measure: to rate the wound infection risk.
timeFrame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
measure: to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
timeFrame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
measure: to measure the recurrence rate
timeFrame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: St.Orsola-Malpighi University Hospital
Study officials:
affiliation: St.Orsola-malpighi Hospital
name: Luca Ansaloni, MD
role: PRINCIPAL_INVESTIGATOR
References: