Back to resultsProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention (POETRY)
Primary Purpose
Incisional Hernia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mesh augmented reinforcement
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia
Eligibility Criteria
Inclusion Criteria:
- Subject has provided informed consent.
- Subject is ≥ 18 years of age at the time of consent.
- Subject will be undergoing an elective midline laparotomy.
Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include:
- High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism
- Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI < 35; ii.Age > 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery
Exclusion Criteria:
- Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.
Subject for which the device is used outside the product IFU, including;
- Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
- Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics
- Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).
- Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.
- Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.
- Subject has participated in an investigational drug or device research study within 30 days of enrollment.
- Subject has a life expectancy of <2 years.
- Subject has an ASA Physical Status Classification System score >3.
- Subject has >5 total risk factors or >2 high-risk factors
Sites / Locations
- CHU Besançon
- CHU de Bordeaux
- CHU de Bordeaux - Hôpital Haut-Lévêque
- CHU Lille
- HCL Louis Pradel
- CHU de Nantes
- CHU de Nîmes
- Centre Hospitalier Lyon Sud
- CHU de Rennes - Hôpital Pontchaillou
- CHU Hopitaux de Rouen
- CHU Strasbourg - Nouvel Hôpital Civil
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hernia prevention cohort
Arm Description
single arm safety study, no control arm
Outcomes
Primary Outcome Measures
Incisional hernia rate
Occurence of incisional hernia assessed by clinical examination and abdominal CT scan
Secondary Outcome Measures
Adverse event
Adverse event incidence reported by number, severity, and relationship to the procedure and device
Time to incisional hernia occurrence
Time to incisional hernia occurrence
Post-operative pain at the site of surgery with Visual Analog Scale (VAS)
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
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
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
Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03912662
Brief Title
ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
Acronym
POETRY
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the high number of AE, it has been determined that it is no longer feasible to clinically interpret the evidence from this study due to the complex factors presented in this patient population, and thus an early termination is justified.
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
September 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hernia prevention cohort
Arm Type
Other
Arm Description
single arm safety study, no control arm
Intervention Type
Device
Intervention Name(s)
Mesh augmented reinforcement
Intervention Description
Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh
Primary Outcome Measure Information:
Title
Incisional hernia rate
Description
Occurence of incisional hernia assessed by clinical examination and abdominal CT scan
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Adverse event
Description
Adverse event incidence reported by number, severity, and relationship to the procedure and device
Time Frame
From the surgery to the 24-month visit
Title
Time to incisional hernia occurrence
Description
Time to incisional hernia occurrence
Time Frame
From the surgery to the 24-month visit
Title
Post-operative pain at the site of surgery with Visual Analog Scale (VAS)
Description
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.
Time Frame
Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
Title
Quality of life questionnaire (QOL) for patient
Description
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.
Time Frame
Month 12, Month 24
Title
Quality of life questionnaire (QOL) for patient
Description
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.
Time Frame
Month 1
Title
Surgeon satisfaction
Description
Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has provided informed consent.
Subject is ≥ 18 years of age at the time of consent.
Subject will be undergoing an elective midline laparotomy.
Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include:
High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism
Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI < 35; ii.Age > 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery
Exclusion Criteria:
Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death.
Subject for which the device is used outside the product IFU, including;
Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics
Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV).
Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia.
Investigator determined that a planned future surgery would interfere with application of mesh reinforcement.
Subject has participated in an investigational drug or device research study within 30 days of enrollment.
Subject has a life expectancy of <2 years.
Subject has an ASA Physical Status Classification System score >3.
Subject has >5 total risk factors or >2 high-risk factors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Bertrand, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Bordeaux - Hôpital Haut-Lévêque
City
Bordeaux
Country
France
Facility Name
CHU Lille
City
Lille
Country
France
Facility Name
HCL Louis Pradel
City
Lyon
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Hopitaux de Rouen
City
Rouen
Country
France
Facility Name
CHU Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
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