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Surgical complications arose early in the study, mainly due to patient complexity, not to study device or implantation. Despite refining protocol to exclude highly complex patients, these issues persisted, leading to the study's early termination.
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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 ProGripâ„¢ 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 ProGripâ„¢ Self-gripping Polyester Mesh through the occurrence of adverse device effects or procedure related adverse events following the use of ProGripâ„¢ Self- gripping Polyester Mesh in subjects undergoing procedures with midline laparotomies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hernia prevention cohort | Other | single arm safety study, no control arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh augmented reinforcement | Device | Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incisional Hernia Rate | Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | AE incidence reported by number, seriousness, and relationship to the procedure and device from the surgery to the 24-month visit | From the surgery to the 24-month visit |
| Time to Incisional Hernia Occurrence |
Not provided
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:
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;
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
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| Name | Affiliation | Role |
|---|---|---|
| Martin Bertrand, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Besançon | France | ||||
| CHU de Bordeaux |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Consented for POETRY Study | Patients consented for POETRY Study and may recieve ProGripâ„¢ Self-Gripping Polyester Mesh. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With ProGripâ„¢ Self-Gripping Polyester Mesh | ProGripâ„¢ Self-Gripping Polyester Mesh: All subjects enrolled who received the ProGripâ„¢ Self-Gripping Polyester Mesh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incisional Hernia Rate | Incisional hernia rate within 24 months of midline laparotomy assessed by CT-scan and physical examination including hernia clinical examination. | 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. | Posted | Count of Participants | Participants | No | 24 months |
|
|
surgery to the 24-month visit
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Treated With ProGripâ„¢ Self-Gripping Polyester Mesh | ProGripâ„¢ Self-Gripping Polyester Mesh: All subjects enrolled will receive the ProGripâ„¢ Self-Gripping Polyester Mesh |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
Due to unsuccessful attempts to limit inclusion of complex patients with severe and multiple comorbidities at high risk of surgical complications that are not related to study device, and due to limited sample size, it was no longer feasible to clinically interpret the evidence from this study, leading to its early termination. Consequently, most planned analyses were not able to be performed. Limited data were collected, which affected the primary and secondary endpoint analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marion Blanc | Medtronic | +33 4 74 08 90 00 | marion.blanc@medtronic.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2020 | Nov 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2021 | Nov 25, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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Time to incisional hernia occurrence from the surgery to the 24-month visit
| 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). | 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. | Month 1, Month 12, Month 24 |
| Surgeon Satisfaction | Surgeon satisfaction on mesh ease of use and manipulability. | Day 0 |
| Patient Satisfaction | The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement. | Month 12, Month 24 |
| Surgeon Satisfaction | Time to position the mesh | Day 0 |
| Bordeaux |
| 33076 |
| France |
| CHU de Bordeaux - Hôpital Haut-Lévêque | Bordeaux | France |
| CHU Lille | Lille | France |
| HCL Louis Pradel | Lyon | France |
| CHU de Nantes | Nantes | 44000 | France |
| CHU de Nîmes | Nîmes | 30029 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | 35033 | France |
| CHU Hopitaux de Rouen | Rouen | France |
| CHU Strasbourg - Nouvel Hôpital Civil | Strasbourg | 67000 | France |
| Screen Failure: Subjects who provide study consent, but then were determined to be ineligible. |
|
| Mesh Removal |
|
| Discontinued: Eligible consented subjects who did not undergo the procedure with the study device. |
|
| Early study termination |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Work | Count of Participants | Participants |
|
| Sport Activity | Count of Participants | Participants |
|
| Counts |
|---|
| 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 | 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. | Posted | Number | Adverse Events | From the surgery to the 24-month visit |
|
|
|
| Secondary | Time to Incisional Hernia Occurrence | Time to incisional hernia occurrence from the surgery to the 24-month visit | 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. | Posted | Median | Full Range | Days to hernia occurrence | From the surgery to the 24-month visit |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale of 0-10 | Day 0, Day 1, Day 8, Month 1, Month 12, Month 24 |
|
|
|
| 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. | 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. | Posted | Number | participants | Month 1, Month 12, Month 24 |
|
|
|
| Secondary | Surgeon Satisfaction | Surgeon satisfaction on mesh ease of use and manipulability. | Surgeons who placed the ProGrip Self-Gripping Polyester Mesh during midline laparotomy procedures. | Posted | Number | surgeons | Day 0 |
|
|
|
| Secondary | Patient Satisfaction | The Club Hernie Patient Satisfaction Survey is used to determine how satisfied a subject is with the mesh placement. | 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. | Posted | Number | participants | Month 12, Month 24 |
|
|
|
| Secondary | Surgeon Satisfaction | Time to position the mesh | Surgeons who placed the ProGrip Self-Gripping Polyester Mesh during midline laparotomy procedures. | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
|
| 2 |
| 32 |
| 10 |
| 32 |
| 17 |
| 32 |
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Vasoplegia syndrome | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Small intestinal resection | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Fistula of small intestine | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Gastrointestinal fistula | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Steatorrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Vascular device infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Vasoplegia syndrome | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Wound evisceration | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Investigation | Investigations | MedDRA 25.0 | Non-systematic Assessment |
|
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Small intestinal resection | Surgical and medical procedures | MedDRA 25.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D010335 | Pathologic Processes |
| Title | Measurements |
|---|---|
|
| Number of Device-Related AEs |
|
| Number of Mesh Placement Procedure-related AEs |
|
| Number of Device-related SAEs |
|
| Number of Mesh Placement Procedure-related SAEs |
|
| Number of Index Procedure related AEs |
|
| Number of Index Procedure related SAEs |
|
| Number of AEs with action taken |
|
| AEs by reason for Seriousness: Hospitalization |
|
| AEs by reason for Seriousness: Death |
|
| AEs by reason for Seriousness: Life threatening illness or injury |
|
| AEs by reason for Seriousness: Permanent impairment of a body structure or body function |
|
| AEs by reason for Seriousness: Medical or surgical intervention |
|
| AEs by Relation to Study Device: Not Related |
|
| AEs by Relation to Study Device: Related |
|
| AEs by Relation to Index Procedure: Not Related |
|
| AEs by Relation to Index Procedure: Related |
|
| AEs by Relation to Mesh Placement Procedure: Not Related |
|
| AEs by Relation to Mesh Placement Procedure: Related |
|
|
| EVA (VAS) Day 8 |
|
|
| EVA (VAS) Month 1 |
|
|
| EVA (VAS) Month 12 |
|
|
| EVA (VAS) Month 24 |
|
|
|
| Month 1: Post-operative discomfort: Tingling (dyesthesia, hyperesthesia, hyperpathia) |
|
|
| Month 1: Post-operative discomfort: Reduced sensitivity |
|
|
| Month 1: Post-operative discomfort: Moderated pain per Visual Analog Scale (VAS) |
|
|
| Month 1: Post-operative discomfort: Other symptoms |
|
|
| Month 1: Post-operative discomfort: Response missing |
|
|
| Month 12 : Post-operative discomfort: No symptoms |
|
|
| Month 12: Post-operative discomfort: Significant pain |
|
|
| Month 12: Post-operative discomfort: Other symptoms |
|
|
| Month 24 : Post-operative discomfort: No symptoms |
|
|
| Month 24: Post-operative discomfort: Reduced sensitivity |
|
|
| Month 1: Location of symptoms: Not applicable |
|
|
| Month 1: Location of symptoms: Side operated on |
|
|
| Month 1: Location of symptoms: Contralateral |
|
|
| Month 1: Location of symptoms: Elsewhere |
|
|
| Month 1: Location of symptoms: Response missing |
|
|
| Month 1: Timing of symptoms: Not applicable |
|
|
| Month 1: Timing of symptoms: after exertion or end of day |
|
|
| Month 1: Timing of symptoms: Anytime |
|
|
| Month 1: Timing of symptoms: During other activities |
|
|
| Month 1: Timing of symptoms: Response missing |
|
|
| Month 1: Frequency of symptoms: Not applicable |
|
|
| Month 1: Frequency of symptoms: Several times per day |
|
|
| Month 1: Frequency of symptoms: Often during day |
|
|
| Month 1: Frequency of symptoms: All day |
|
|
| Month 1: Frequency of symptoms: 24 hours a day |
|
|
| Month 1: Frequency of symptoms: Response missing |
|
|
| Month 1: Impact of symptoms on activities: Not applicable |
|
|
| Month 1: Impact of symptoms on activities: prohibits certain activities |
|
|
| Month 1: Impact of symptoms on activities: temporary stop of activities |
|
|
| Month 1: Impact of symptoms on activities: continue activities |
|
|
| Month 1: Impact of symptoms on activities: response missing |
|
|
| Month 1: pre- and post-operative pain: Not applicable |
|
|
| Month 1: pre- and post-operative pain: post-operative discomfort < Hernia discomfort |
|
|
| Month 1: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort |
|
|
| Month 1: pre- and post-operative pain: response missing |
|
|
| Month 12: Location of symptoms: Not applicable |
|
|
| Month 12: Location of symptoms: Elsewhere |
|
|
| Month 12: Timing of symptoms: Not applicable |
|
|
| Month 12: Timing of symptoms: After exertion or end of day |
|
|
| Month 12: Frequency of symptoms: Not applicable |
|
|
| Month 12: Frequency of symptoms: Often during day |
|
|
| Month 12: Impact of symptoms on activities: Not applicable |
|
|
| Month 12: Impact of symptoms on activities: Prohibits certain activities |
|
|
| Month 12: pre- and post-operative pain: Not applicable |
|
|
| Month 12: pre- and post-operative pain: Post-operative discomfort > Hernia discomfort |
|
|
| Month 12: pre- and post-operative pain: Response missing |
|
|
| Month 24: Location of symptoms: Not applicable |
|
|
| Month 24: Location of symptoms: Bilateral |
|
|
| Month 24: Timing of symptoms: Not applicable |
|
|
| Month 24: Timing of symptoms: Anytime |
|
|
| Month 24: Frequency of symptoms: Not applicable |
|
|
| Month 24: Impact of symptoms on activities: Not applicable |
|
|
| Month 24: Impact of symptoms on activities: Does not disrupt activities |
|
|
| Month 24: pre- and post-operative pain: Not applicable |
|
|
| Month 24: pre- and post-operative pain: post-operative discomfort < Hernia discomfort |
|
|
| Month 12: Perception of structure of abdominal wall: Solid |
|
|
| Month 12: Perception of lump in abdominal wall: No |
|
|
| Month 12: Perception of lump in abdominal wall: Elsewhere |
|
|
| Month 24: Perception of structure of abdominal wall: Solid |
|
|
| Month 24: Perception of lump in abdominal wall: No |
|
|
| Title | Measurements |
|---|---|
|
| Cuttable : Satisfactory |
|
|
| Cuttable : Not Stated |
|
|
| Mesh shape memory : Satisfactory |
|
|
| Mesh shape memory : Unsatisfactory |
|
|
| Mesh shape memory : Not Stated |
|
|
| Mesh placement - adhesion to the wall |
|
|
| Mesh placement - absence of laying direction |
|
|
| Mesh placement - shape memory |
|
|
| Mesh placement - transparency |
|
|
| Mesh placement - easy to reposition |
|
|
|
| Month 12: Strength of abdominal wall = Excellent |
|
|
| Month 12: Strength of abdominal wall = Good |
|
|
| Month 12: Strength of abdominal wall = Moderate |
|
|
| Month 12: Strength of abdominal wall = Poor |
|
|
| Month 12: Strength of abdominal wall = response missing |
|
|
| Month 24: Repeat Procedure Performed = No |
|
|
| Month 24: Strength of abdominal wall = Excellent |
|
|
| Month 24: Strength of abdominal wall = Good |
|
|
| Month 24: Strength of abdominal wall = Poor |
|
|