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

NCT00614419 | Completed Phase 4

• 1 other identifier: 81/2002/O
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Keywords

Hernioplasty; polypropylene; extracellular matrix; xenograft

Outcome Measures

Primary Outcomes (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

  1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

Secondary Outcomes (4)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

The Lichtenstein tension-free hernioplasty with polypropylene mesh

Device: Prolene Polypropylene Mesh

2

EXPERIMENTAL

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

Interventions

Prolene Polypropylene Mesh 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.

Also known as: PP

1

Surgisis Inguinal Hernia Matrix 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.

Also known as: SIHM

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

St.Orsola-Malpighi University Hospital

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Luca Ansaloni, MD

  St.Orsola-malpighi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2003
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

IT (1)