Incisional Hernia
Conditions
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.
Interventions
DEVICEMesh augmented reinforcement
Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has provided informed consent. 2. Subject is ≥ 18 years of age at the time of consent. 3. Subject will be undergoing an elective midline laparotomy. 4. 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: 1. 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 2. 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
1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death. 2. Subject for which the device is used outside the product IFU, including; 1. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period 2. 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 3. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV). 3. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia. 4. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement. 5. Subject has participated in an investigational drug or device research study within 30 days of enrollment. 6. Subject has a life expectancy of \<2 years. 7. Subject has an ASA Physical Status Classification System score \>3. 8. Subject has \>5 total risk factors or \>2 high-risk factors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Hernia Rate | 24 months | Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Incisional Hernia Occurrence | From the surgery to the 24-month visit | Time to incisional hernia occurrence from the surgery to the 24-month visit |
| Post-operative Pain at the Site of Surgery | Day 0, Day 1, Day 8, Month 1, Month 12, Month 24 | 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). |
| Adverse Event | From the surgery to the 24-month visit | AE incidence reported by number, seriousness, and relationship to the procedure and device from the surgery to the 24-month visit |
| Surgeon Satisfaction | Day 0 | Surgeon satisfaction on mesh ease of use and manipulability. |
| Patient Satisfaction | Month 12, Month 24 | The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement. |
| Quality of Life Questionnaire (QOL) for Patient | Month 1, Month 12, Month 24 | 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. |
Countries
France
Participant flow
Pre-assignment details
A subject is considered enrolled in the study when it is confirmed they meet all pre-operative inclusion and no exclusion criteria, the Informed Consent Form is signed and they have been implanted with the device.
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With ProGrip™ Self-Gripping Polyester Mesh ProGrip™ Self-Gripping Polyester Mesh: All subjects enrolled who received the ProGrip™ Self-Gripping Polyester Mesh | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Adverse Event and Death | 1 |
| Overall Study | Death | 1 |
| Overall Study | Discontinued: Eligible consented subjects who did not undergo the procedure with the study device. | 2 |
| Overall Study | Early study termination | 20 |
| Overall Study | Mesh Removal | 1 |
| Overall Study | Screen Failure: Subjects who provide study consent, but then were determined to be ineligible. | 1 |
Baseline characteristics
| Characteristic | Patients Treated With ProGrip™ Self-Gripping Polyester Mesh | — |
|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 13.19 | — |
| BMI | 25.5 kg/m^2 STANDARD_DEVIATION 5.66 | — |
| Height | 169.5 cm STANDARD_DEVIATION 9.26 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
| Sport Activity Intense (>1x/week) | 3 Participants | — |
| Sport Activity Moderate (1x/week) | 14 Participants | — |
| Sport Activity None | 14 Participants | — |
| Sport Activity Sporadic | 1 Participants | — |
| Weight | 73.6 kg STANDARD_DEVIATION 17.96 | — |
| Work Administrative work | 4 Participants | — |
| Work Moderately physical labor | 5 Participants | — |
| Work Not Provided | 4 Participants | — |
| Work Physical labor | 3 Participants | — |
| Work Unemployed | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 32 |
| other Total, other adverse events | 17 / 32 |
| serious Total, serious adverse events | 10 / 32 |
Outcome results
Primary
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
Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Incisional Hernia Rate | 1 Participants |
Secondary
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
Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by Relation to Study Device: Not Related | 31 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by Relation to Study Device: Related | 8 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Total Number of Adverse Events | 39 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of SAEs | 25 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of non-Serious AEs | 14 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of Device-Related AEs | 8 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of Mesh Placement Procedure-related AEs | 5 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of Device-related SAEs | 6 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of Mesh Placement Procedure-related SAEs | 3 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of Index Procedure related AEs | 27 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of Index Procedure related SAEs | 14 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | Number of AEs with action taken | 38 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by reason for Seriousness: Hospitalization | 18 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by reason for Seriousness: Death | 2 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by reason for Seriousness: Life threatening illness or injury | 8 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by reason for Seriousness: Permanent impairment of a body structure or body function | 1 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by reason for Seriousness: Medical or surgical intervention | 19 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by Relation to Index Procedure: Not Related | 12 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by Relation to Index Procedure: Related | 27 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by Relation to Mesh Placement Procedure: Not Related | 24 Adverse Events |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Adverse Event | AEs by Relation to Mesh Placement Procedure: Related | 4 Adverse Events |
Secondary
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
Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 12: Repeat Procedure Performed = No | 14 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 12: Repeat Procedure Performed = Response Missing | 2 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 12: Strength of abdominal wall = Excellent | 5 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 12: Strength of abdominal wall = Good | 5 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 12: Strength of abdominal wall = Moderate | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 12: Strength of abdominal wall = Poor | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 12: Strength of abdominal wall = response missing | 4 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 24: Repeat Procedure Performed = No | 4 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 24: Strength of abdominal wall = Excellent | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 24: Strength of abdominal wall = Good | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Patient Satisfaction | Month 24: Strength of abdominal wall = Poor | 0 participants |
Secondary
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
Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Post-operative Pain at the Site of Surgery | EVA (VAS) Day 0 | 3.8 score on a scale of 0-10 | Standard Deviation 2.94 |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Post-operative Pain at the Site of Surgery | EVA (VAS) Day 1 | 3.7 score on a scale of 0-10 | Standard Deviation 2.73 |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Post-operative Pain at the Site of Surgery | EVA (VAS) Day 8 | 1.9 score on a scale of 0-10 | Standard Deviation 2.42 |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Post-operative Pain at the Site of Surgery | EVA (VAS) Month 1 | 0.4 score on a scale of 0-10 | Standard Deviation 0.91 |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Post-operative Pain at the Site of Surgery | EVA (VAS) Month 12 | 0.5 score on a scale of 0-10 | Standard Deviation 1.81 |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Post-operative Pain at the Site of Surgery | EVA (VAS) Month 24 | 0 score on a scale of 0-10 | Standard Deviation 0 |
Secondary
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
Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1 : Post-operative discomfort: No symptoms | 16 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1 : Post-operative discomfort: Discomfort | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Post-operative discomfort: Tingling (dyesthesia, hyperesthesia, hyperpathia) | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Post-operative discomfort: Reduced sensitivity | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Post-operative discomfort: Moderated pain per Visual Analog Scale (VAS) | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Post-operative discomfort: Other symptoms | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Post-operative discomfort: Response missing | 8 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12 : Post-operative discomfort: No symptoms | 14 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Post-operative discomfort: Significant pain | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Post-operative discomfort: Other symptoms | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24 : Post-operative discomfort: No symptoms | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Post-operative discomfort: Reduced sensitivity | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Location of symptoms: Not applicable | 17 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Location of symptoms: Side operated on | 6 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Location of symptoms: Contralateral | 2 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Location of symptoms: Elsewhere | 2 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Location of symptoms: Response missing | 7 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Timing of symptoms: Not applicable | 19 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Timing of symptoms: after exertion or end of day | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Timing of symptoms: Anytime | 2 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Timing of symptoms: During other activities | 2 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Timing of symptoms: Response missing | 7 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Frequency of symptoms: Not applicable | 19 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Frequency of symptoms: Several times per day | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Frequency of symptoms: Often during day | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Frequency of symptoms: All day | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Frequency of symptoms: 24 hours a day | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Frequency of symptoms: Response missing | 7 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Impact of symptoms on activities: Not applicable | 19 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Impact of symptoms on activities: prohibits certain activities | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Impact of symptoms on activities: temporary stop of activities | 2 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Impact of symptoms on activities: continue activities | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: Impact of symptoms on activities: response missing | 7 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: pre- and post-operative pain: Not applicable | 21 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: pre- and post-operative pain: post-operative discomfort < Hernia discomfort | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 1: pre- and post-operative pain: response missing | 7 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Location of symptoms: Not applicable | 15 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Location of symptoms: Elsewhere | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Timing of symptoms: Not applicable | 15 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Timing of symptoms: After exertion or end of day | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Frequency of symptoms: Not applicable | 15 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Frequency of symptoms: Often during day | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Impact of symptoms on activities: Not applicable | 15 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Impact of symptoms on activities: Prohibits certain activities | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: pre- and post-operative pain: Not applicable | 14 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: pre- and post-operative pain: Response missing | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Location of symptoms: Not applicable | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Location of symptoms: Bilateral | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Timing of symptoms: Not applicable | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Timing of symptoms: Anytime | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Frequency of symptoms: Not applicable | 4 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Impact of symptoms on activities: Not applicable | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Impact of symptoms on activities: Does not disrupt activities | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: pre- and post-operative pain: Not applicable | 3 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: pre- and post-operative pain: post-operative discomfort < Hernia discomfort | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Perception of structure of abdominal wall: Solid | 16 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Perception of lump in abdominal wall: No | 15 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 12: Perception of lump in abdominal wall: Elsewhere | 1 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Perception of structure of abdominal wall: Solid | 4 participants |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Quality of Life Questionnaire (QOL) for Patient | Month 24: Perception of lump in abdominal wall: No | 4 participants |
Secondary
Surgeon Satisfaction
Surgeon satisfaction on mesh ease of use and manipulability.
Time frame: Day 0
Population: Surgeons who placed the ProGrip Self-Gripping Polyester Mesh during midline laparotomy procedures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Flexibility of the Mesh : Not Stated | 1 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Cuttable : Satisfactory | 24 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Cuttable : Not Stated | 2 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh shape memory : Satisfactory | 24 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Flexibility of the Mesh : Satisfactory | 25 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh shape memory : Unsatisfactory | 1 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh shape memory : Not Stated | 1 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh placement - adhesion to the wall | 17 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh placement - absence of laying direction | 8 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh placement - shape memory | 5 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh placement - transparency | 8 surgeons |
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | Mesh placement - easy to reposition | 12 surgeons |
Secondary
Surgeon Satisfaction
Time to position the mesh
Time frame: Day 0
Population: Surgeons who placed the ProGrip Self-Gripping Polyester Mesh during midline laparotomy procedures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Surgeon Satisfaction | 8.0 minutes | Standard Deviation 6.34 |
Secondary
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
Population: Patients who received ProGrip Self-Gripping Polyester Mesh for suture line reinforcement after midline laparotomy, met all of the inclusion criteria, and none of the exclusion criteria.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With ProGrip Self-Gripping Polyester Mesh and 24-Months of Study Follow-up | Time to Incisional Hernia Occurrence | 384 Days to hernia occurrence |