This trial is active, not recruiting.

Condition hernia, inguinal
Treatments parietex progrip, low weight polypropylene mesh
Phase phase 4
Sponsor Sofradim Production
Collaborator Covidien
Start date October 2008
End date June 2012
Trial size 600 participants
Trial identifier NCT00827944, SC 0607/1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
Parietex ProGrip
parietex progrip
Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
(Active Comparator)
Low weight polypropylene mesh
low weight polypropylene mesh
Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Primary Outcomes

Pain assessment during the first three months and at one year after surgery using a visual analogue scale (VAS) and a Surgical Pain Scales
time frame: Preop, discharge, D7, M1, M3, M12 months after surgery.

Secondary Outcomes

Pain inducing social consequences using the Activity Assessment Scale investigating functional status
time frame: Preop, M1, M3, M12 months after surgery.
Foreign body sensation
time frame: M1, M3, M12 months after surgery.
Chronic pain defined as pain lasting more than 3 months using VAS score.
time frame: 3 months
Wound complications and hernia recurrences
time frame: Whole follow up
Other post-operative complications
time frame: Whole follow up
Return to normal daily activities and to work
time frame: Effective date
Safety (incidence of serious adverse events and serious incidents)
time frame: Whole follow up

Eligibility Criteria

Male participants from 31 years up to 74 years old.

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 - bBilateral inguinal hernia - Recurrence

Additional Information

Official title ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Sofradim Production.