Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis
- Conditions
- Hernia, Inguinal
- Registration Number
- NCT00614419
- 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
- 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
- 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
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
St.Orsola-Malpighi University Hospital🇮🇹Bologna, Italy