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

PHASE4CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

December 31, 2003

Study Completion Date

December 31, 2003

Conditions
Hernia, Inguinal
Interventions
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.

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.

Trial Locations (1)

40138

St.Orsola-Malpighi University Hospital, Bologna

All Listed Sponsors
lead

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

NCT00614419 - Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis | Biotech Hunter | Biotech Hunter