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

Purpose

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.

Condition	Intervention	Phase
Hernia, Inguinal	Device: Prolene Polypropylene Mesh Device: Surgisis Inguinal Hernia Matrix	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Prospective Randomized, Double-Blind, Controlled Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis ES Soft Tissue Graft

Resource links provided by NLM:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
to rate the wound infection risk. [ Time Frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
to measure the recurrence rate [ Time Frame: 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	January 2003
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: SIHM

Arms

Assigned Interventions

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 Name: 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 Name: SIHM

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:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614419

Locations

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

Sponsors and Collaborators

St. Orsola Hospital

Investigators

Principal Investigator:

Luca Ansaloni, MD

St.Orsola-malpighi Hospital

More Information

No publications provided

Responsible Party:	Dr. Luca Ansaloni, Unit of Surgery, St.Orsola-Malpighi Hospital - University of Bologna
ClinicalTrials.gov Identifier:	NCT00614419 History of Changes
Other Study ID Numbers:	81/2002/O
Study First Received:	January 31, 2008
Last Updated:	February 12, 2008
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by St. Orsola Hospital:

Hernioplasty
polypropylene
extracellular matrix
xenograft

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on June 18, 2013