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

NCT ID: NCT00614419

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2003-12-31

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.

Conditions

Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

The Lichtenstein tension-free hernioplasty with polypropylene mesh

Group Type: ACTIVE_COMPARATOR

Prolene Polypropylene Mesh

Intervention Type: DEVICE

The Lichtenstein tension-free hernioplasty consists of a swatch of polypropylene mesh, partway slit 1 cm from its inferior edge to accommodate the spermatic cord. The mesh is sutured circumferentially to the internal oblique abdominal muscle, the rectus sheath and the shelving edge of the inguinal ligament. The tails of the mesh are drawn around the cord and the inferior edge of each tail is sutured to the inguinal ligament. In case of direct hernias, no effort is made to repair the hernia itself. In indirect hernias the sac is excised, except for sliding hernias. The polypropylene mesh group: in this group of patients the polypropylene mesh will be fixed by the above mentioned sutures in Prolene 3/0.

2

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.

Group Type: EXPERIMENTAL

Surgisis Inguinal Hernia Matrix

Intervention Type: DEVICE

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.

Interventions

Prolene Polypropylene Mesh

The Lichtenstein tension-free hernioplasty consists of a swatch of polypropylene mesh, partway slit 1 cm from its inferior edge to accommodate the spermatic cord. The mesh is sutured circumferentially to the internal oblique abdominal muscle, the rectus sheath and the shelving edge of the inguinal ligament. The tails of the mesh are drawn around the cord and the inferior edge of each tail is sutured to the inguinal ligament. In case of direct hernias, no effort is made to repair the hernia itself. In indirect hernias the sac is excised, except for sliding hernias. The polypropylene mesh group: in this group of patients the polypropylene mesh will be fixed by the above mentioned sutures in Prolene 3/0.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

PP; SIHM

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Unit of Surgery, St.Orsola-Malpighi Hospital - University of Bologna

Principal Investigators

Luca Ansaloni, MD

Role: PRINCIPAL_INVESTIGATOR

St.Orsola-malpighi Hospital

Locations

St.Orsola-Malpighi University Hospital

Bologna, , Italy

Countries

Italy

Other Identifiers

81/2002/O

Identifier Type: -

Identifier Source: org_study_id