Skip to main content
OpenTrials
Completed

NCT Number: NCT00614419

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

St.Orsola-Malpighi University Hospital

Bologna, 40138, Italy

About this study

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:

  • to determine the safety of the Lichtenstein's hernioplasty with Surgisis ES by noting any complications observed intraoperatively and postoperatively
  • 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:

  • 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.
  • to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
  • to measure the postoperative health general status and quality of life with the Short Form 36 (SF-36) questionnaire.
  • to rate the wound infection risk.
  • to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
  • to measure the recurrence rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PP

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.

Other names: SIHM

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

    Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

Secondary outcomes

  1. to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).

    Time frame: 3, 6 months, 1, 2, 3, 4, 5 years

  2. to rate the wound infection risk.

    Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

  3. to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.

    Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

  4. to measure the recurrence rate

    Time frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Feb 13, 2008
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.