Parietex Progrip Study

Medtronic

Status and phase: Completed; Phase 4

Conditions: Hernia, Inguinal

Treatments: Device: Parietex Progrip; Device: Low weight polypropylene mesh

Study type: Interventional

Funder types: Industry

Identifiers

NCT00827944

SC 0607/1

Details and patient eligibility

About

The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.

Full description

• Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
• Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures.
• Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study.
• 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.

Enrollment: 603 patients

Sex: Male

Ages: 31 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All male patients at participating centers with a primary, uncomplicated inguinal hernia.
• Collar of the defect ≤ 4 cm
• Signed informed consent

Exclusion criteria

• 30 years ≥ Age ≥ 75 years
• Emergency procedure
• Inclusion in other trials
• Bilateral inguinal hernia
• Recurrence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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603 participants in 2 patient groups

1

Active Comparator group

Description:

Parietex ProGrip

Treatment:

Device: Parietex Progrip

2

Active Comparator group

Description:

Low weight polypropylene mesh

Treatment:

Device: Low weight polypropylene mesh