Parietex Progrip Study
|Hernia, Inguinal||Device: Parietex Progrip Device: Low weight polypropylene mesh||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia|
- Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) [ Time Frame: 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.
- Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS) [ Time Frame: 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).
- Foreign Body Sensation [ Time Frame: 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 [ Time Frame: 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.
- Wound Complications and Hernia Recurrences [ Time Frame: M12 after surgery ]
- Return to Work and to Normal Daily Activities [ Time Frame: Effective date ]
- Other Post-operative Complications [ Time Frame: M12 after surgery ]
|Study Start Date:||October 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Device: Parietex Progrip
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
Active Comparator: 2
Low weight polypropylene mesh
Device: Low weight polypropylene mesh
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827944
|Universitaire Ziekenhuizen Leuven|
|Leuven, Belgium, 3000|
|Bremen, Germany, 28177|
|Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik|
|Fulda, Germany, D- 36039 Fulda|
|Eindhoven, Netherlands, 5623 EJ|
|Medical Center Linköping|
|Linköping, Sweden, 582 24|
|Centre of clinical research|
|Västeras-, Sweden, 721 89|
|Glasgow, United Kingdom, G11 6NT|
|Imperial College London / Faculty of Medecine|
|London, United Kingdom, W2 1NY|
|Plymouth, United Kingdom, PL6|