ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
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|ClinicalTrials.gov Identifier: NCT03912662|
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : October 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Incisional Hernia||Device: Mesh augmented reinforcement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Poetry Study - PrOGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia|
|Actual Study Start Date :||September 18, 2019|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
|Hernia prevention cohort||
Device: Mesh augmented reinforcement
Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh
- Incisional hernia rate [ Time Frame: 24 months ]Occurence of incisional hernia assessed by clinical examination and abdominal CT scan
- Adverse event [ Time Frame: From the surgery to the 24-month visit ]Adverse event incidence reported by number, severity, and relationship to the procedure and device
- Time to incisional hernia occurrence [ Time Frame: From the surgery to the 24-month visit ]Time to incisional hernia occurrence
- Post-operative pain at the site of surgery with Visual Analog Scale (VAS) [ Time Frame: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24 ]
Assessment of post-operative pain using a 0 to 10 Visual Analogic Scale. Worst pain experienced over the last 24 hours.
Mild pain for VAS score between 0 and 3. Moderate pain for VAS score >3 and ≤6. Severe pain for VAS score >6.
- Quality of life questionnaire (QOL) for patient [ Time Frame: Month 12, Month 24 ]Assessment with Club Hernie registry QOL questionnaire of patient treated for suture line mesh reinforcement for long follow-up. Two sets of self-administered QOL and patient satisfaction questionnaire will be administered by phone call at 12 and 24 months.
- Quality of life questionnaire (QOL) for patient [ Time Frame: Month 1 ]Assessment with Club Hernie registry QOL questionnaire of patient treated for suture line mesh reinforcement for long follow-up. A self-administered QOL questionnaire will be administered at 1 month.
- Surgeon satisfaction [ Time Frame: Day 0 ]Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912662
|Contact: Houria Belalit, MS||+33 (0) 4 74 08 90 00 (#1381)||email@example.com|
|Contact: Julie Pillat, PharmD||+33 (0) 474 089 000 (#1527)||firstname.lastname@example.org|
|CHU de Bordeaux||Not yet recruiting|
|Bordeaux, France, 33076|
|Clinique Saint-Charles||Not yet recruiting|
|La Roche-sur-Yon, France, 85016|
|CHU de Nantes||Not yet recruiting|
|Nantes, France, 44000|
|CHU de Nîmes||Not yet recruiting|
|Nîmes, France, 30029|
|Centre Hospitalier Lyon Sud||Recruiting|
|Pierre-Bénite, France, 69310|
|CHU de Rennes - Hôpital Pontchaillou||Not yet recruiting|
|Rennes, France, 35033|
|Centre Hospitalier Valenciennes||Not yet recruiting|
|Valenciennes, France, 59322|
|Principal Investigator:||Michel Prudhomme, MD||CHU de Nîmes|