Interventional, prospective, multicenter, post-marketing clinical follow-up study. After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health. As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.
The primary objective of this investigation is to confirm the efficacy of ProGrip™ Self-gripping Polyester Mesh to reduce the incidence of incisional hernia within 24 months post-operatively in subjects undergoing procedures with midline laparotomies. Secondary Objective The secondary objective of this investigation is to confirm the safety of ProGrip™ Self-gripping Polyester Mesh through the occurrence of adverse device effects or procedure related adverse events following the use of ProGrip™ Self- gripping Polyester Mesh in subjects undergoing procedures with midline laparotomies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh
CHU Besançon
Besançon, France
CHU de Bordeaux
Bordeaux, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Bordeaux, France
CHU Lille
Lille, France
Incisional Hernia Rate
Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination.
Time frame: 24 months
Adverse Event
AE incidence reported by number, seriousness, and relationship to the procedure and device from the surgery to the 24-month visit
Time frame: From the surgery to the 24-month visit
Time to Incisional Hernia Occurrence
Time to incisional hernia occurrence from the surgery to the 24-month visit
Time frame: From the surgery to the 24-month visit
Post-operative Pain at the Site of Surgery
Post-operative pain at the site of the surgery was measured at days 0, 1, 8 and months 1, 12, 24 using a Visual Analog Scale - a psychometric response scale (0-10) (0 no pain, 10 the worst) either during systematic clinical visit or by phone call when a subject is already discharged. (Worst pain experienced over the last 24 hours).
Time frame: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
Quality of Life Questionnaire (QOL) for Patient
Assessment with Club Hernie Registry QOL questionnaire of patients treated with ProGrip Self-Gripping Polyester Mesh for suture line mesh reinforcement. . Two sets of self-administered QOL were administered; one for 1 month and one for 12- and 24-month.
Time frame: Month 1, Month 12, Month 24
Surgeon Satisfaction
Surgeon satisfaction on mesh ease of use and manipulability.
Time frame: Day 0
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HCL Louis Pradel
Lyon, France
CHU de Nantes
Nantes, France
CHU de Nîmes
Nîmes, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, France
CHU Hopitaux de Rouen
Rouen, France
...and 1 more locations
Patient Satisfaction
The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement.
Time frame: Month 12, Month 24
Surgeon Satisfaction
Time to position the mesh
Time frame: Day 0