Parietex Progrip Study

ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia

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.

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.

Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.

Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures

Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)

Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.

Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)

Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).

Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.

Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.

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

Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.