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

Prospective Randomized, Double-blind, Controlled Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis ES Soft Tissue Graft

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Device: Prolene Polypropylene Mesh; Device: Surgisis Inguinal Hernia Matrix

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • St.Orsola-Malpighi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; The Lichtenstein tension-free hernioplasty with polypropylene mesh	Device: 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.; Other Names: PP
EXPERIMENTAL: 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.	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.; Other Names: SIHM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
to rate the wound infection risk.	1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years
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 measure the recurrence rate	1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Luca Ansaloni, MD, St.Orsola-malpighi Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (ACTUAL): December 1, 2003
• Study Completion (ACTUAL): December 1, 2003

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: February 12, 2008
• First Posted (ESTIMATE): February 13, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: xenograft; polypropylene; extracellular matrix; Hernioplasty
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 81/2002/O