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| Name | Class |
|---|---|
| FGK Clinical Research GmbH | INDUSTRY |
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Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resorbable Mesh | Other | Phasix Mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resorbable Mesh | Device | Phasix Mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence Rate | Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence. | 60 Months |
| Surgical Site Infections | Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections | 60 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog Scale | Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception. |
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Inclusion Criteria:
Subjects must have met all of the criteria listed below to be enrolled in the study:
1. Subject must have been 18 years of age or older 2. Subject or subject's legally authorized representative must have given written informed consent 3. Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4) 3. Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0) 4. Subject must have had a hernia greater than 10 cm2 and ≤350 cm2 5. Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4) 5. Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0) 6. Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol) 7. Subjects must have had 1 or more of the following pre-study conditions:
Exclusion Criteria:
Subjects were excluded from study enrollment if any of the following criteria were met:
1. Subject's hernia had recurred more than once (protocol version 1.4)
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| Name | Affiliation | Role |
|---|---|---|
| Scott Roth, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92103 | United States | ||
| Florida Hospital/Celebration Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36102523 | Derived | Roth JS, Anthone GJ, Selzer DJ, Poulose BK, Pierce RA, Bittner JG, Hope WW, Dunn RM, Martindale RG, Goldblatt MI, Earle DB, Romanelli JR, Mancini GJ, Greenberg JA, Linn JG, Parra-Davila E, Sandler BJ, Deeken CR, Badhwar A, Salluzzo JL, Voeller GR. Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up. J Am Coll Surg. 2022 Dec 1;235(6):894-904. doi: 10.1097/XCS.0000000000000363. Epub 2022 Nov 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phasix Mesh Group | Patients requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2017 | Oct 23, 2020 |
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| 60 Months |
| Device Related Adverse Events | Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term "incidence" is an error and is reported here as the rate of device related adverse events. | 60 Months |
| Rate of Re-operation Due to the Index Hernia Repair | Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair. | 60 Months |
| Carolinas Comfort Scale® (CCS) | Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-Month follow-up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results. | 60 Months |
| SF-12 Questionnaire | The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 60 Months |
| Surgical Procedure Time as Measured From Incision to Closure | Surgical procedure time as measured from incision to closure (skin to skin) | 1 day |
| Length of Hospital Stay | Time in days from hospital admission to discharge | 35 days |
| Celebration |
| Florida |
| 34747 |
| United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40506 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| University of Massachusetts Worcester | Worcester | Massachusetts | 01655 | United States |
| Methodist Health System | Omaha | Nebraska | 68114 | United States |
| Southeast Area Health and Education Center | Wilmington | North Carolina | 28403 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Univerity of Tennessee Health Science Center | Germantown | Tennessee | 38163 | United States |
| University of Tennessee Health Sciences Center | Knoxville | Tennessee | 37996 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| University of Wisconsin System | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phasix Mesh | Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Hernia Recurrence Rate | Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence. | Posted | Count of Participants | Participants | 60 Months |
|
|
| |||||||||||||||||||||||||||
| Primary | Surgical Site Infections | Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections | Posted | Count of Participants | Participants | 60 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Pain Visual Analog Scale | Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception. | Posted | Mean | Standard Deviation | cm | 60 Months |
|
| |||||||||||||||||||||||||||
| Secondary | Device Related Adverse Events | Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term "incidence" is an error and is reported here as the rate of device related adverse events. | Posted | Count of Participants | Participants | 60 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Rate of Re-operation Due to the Index Hernia Repair | Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair. | Posted | Count of Participants | Participants | 60 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Carolinas Comfort Scale® (CCS) | Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-Month follow-up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results. | The number of participants noted at each time point differ from the overall number (121) due to only having the eligible questionnaires being analyzed. The number of eligible questionnaires range from 52 to 111. | Posted | Mean | Standard Error | Score on a scale | 60 Months |
| |||||||||||||||||||||||||||
| Secondary | SF-12 Questionnaire | The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Posted | Mean | Standard Deviation | Absolute Change from Baseline | 60 Months |
|
| |||||||||||||||||||||||||||
| Secondary | Surgical Procedure Time as Measured From Incision to Closure | Surgical procedure time as measured from incision to closure (skin to skin) | Posted | Mean | Full Range | Minutes | 1 day |
|
| |||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay | Time in days from hospital admission to discharge | Posted | Median | Full Range | Days | 35 days |
|
|
60 Months
In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate.
Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phasix Mesh | Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL). | 7 | 121 | 49 | 121 | 104 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cardio-respiratory Arrest | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal Adhesions | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal Wall Disorder | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Colonic Pseudo-obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Peptic Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Generalized Oedema | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Clostidium Deficile Infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Post-operative Wound Infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Cardiac Valve Replacement Complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Incision Site Erythema | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Incision Site Haematoma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Incisional Hernia, Obstructive | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Post Procedural Haematoma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Postoperative Wound Complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Skin Flap Necrosis | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Ureteric Injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Muscle Necrosis | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Pseudomyxoma Peritonei | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| Embolic Cerebral Infarction | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Serotonin Syndrome | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Adnexa Uteri Cyst | Reproductive system and breast disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Restrictive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Skin Necrosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Aortic Aneurysm | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Intra-abdominal Haematoma | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
|
The study was designed as a single arm observational trial without pre-defined statistical hypotheses (theories) to test; therefore, data can only be described and no treatment or conclusions can be made.
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer / Sr. Director Medical Affairs | Becton Dickinson | 401-479-1253 | dawn.heimer@bd.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2018 | Oct 26, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
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