Parietex Progrip Study

Phase 4

Completed

Interventions: Device: Parietex Progrip
Device: Low weight polypropylene mesh

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	Parietex Progrip	Parietex ProGrip
2	Low weight polypropylene mesh	Low weight polypropylene mesh

Primary Outcome Measures

Name	Time	Method
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)	M3, M12 after surgery	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).
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)	M3, M12 after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Other Post-operative Complications	M12 after surgery
Return to Work and to Normal Daily Activities	Effective date
Wound Complications and Hernia Recurrences	M12 after surgery
Foreign Body Sensation	M1, M3, M12 months after surgery	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	3 months after surgery	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.

Locations (9): Klinikum Bremen-Mitte
🇩🇪
Bremen, Germany
Catharina-ziekenhuis
🇳🇱
Eindhoven, Netherlands
Medical Center Linköping
🇸🇪
Linköping, Sweden
Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik
🇩🇪
Fulda, Germany
Centre of clinical research
🇸🇪
Västeras-, Sweden
Imperial College London / Faculty of Medecine
🇬🇧
London, United Kingdom
Western Infirmary
🇬🇧
Glasgow, United Kingdom
Derriford Hospital
🇬🇧
Plymouth, United Kingdom
Universitaire Ziekenhuizen Leuven
🇧🇪
Leuven, Belgium