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The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbsorbaTack | Device | Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm. Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable". | Discharge, Month 1, Month 6, Month 12 |
| Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life. The Physical Composite Score was computed using the scores of twelve questions and 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Rosen | Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals at Case Medical Center | Cleveland | Ohio | 44194 | United States | ||
| Greenville Hospital System |
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Between November 4, 2008 and November 4, 2010, 117 subjects signed informed consent for the inguinal hernia arm of the study and 113 for the ventral arm. Of those subjects who consented, 106 and 110 were randomized to a treatment group (either AbsorbaTack™ or ProTack™) for inguinal and ventral hernia repair, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inguinal Arm | Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types. |
| FG001 | Ventral Arm | Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 inguinal pt assigned to receive AbsorbaTack was treated with ProTack and one patient assigned to receive ProTack received AbsorbaTack. These patients are included in the "intent to treat" population above, but were omitted from the safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inguinal Arm - AbsorbaTack | Inguinal hernia study arm with AbsorbaTack as treatment. |
| BG001 | Inguinal Arm - ProTack | Inguinal hernia study arm with ProTack as treatment. |
| 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 | Postoperative Pain | Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm. Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable". | 1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Discharge, Month 1, Month 6, Month 12 |
|
Adverse events collected from time of randomization through 1 year.
Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set.
Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set
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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 | Inguinal Arm - AbsorbaTack | Inguinal hernia study arm with AbsorbaTack as treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Carlson, Clinical Project Manager | Covidien | (203) 821-4734 | jessica.carlson@covidien.com |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006555 | Hernia, Ventral |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ProTack | Device | Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body. |
|
| Pre-op, Month 1, Month 6, 1 year |
| Hernia Recurrence | Discharge, 1 Month, 6 Month, 1 year |
| Greenville |
| South Carolina |
| 29605 |
| United States |
| BG002 | Ventral Arm - Absorbatack | Ventral hernia study arm with AbsorbaTack as treatment. |
| BG003 | Ventral Arm - ProTack | Ventral hernia study arm with ProTack as treatment. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Ventral Arm - Absorbatack |
| OG003 | Ventral Arm - ProTack |
|
|
| Primary | Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events | Posted | Number | participants | One year |
|
|
|
| Secondary | Quality of Life | Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life. The Physical Composite Score was computed using the scores of twelve questions and 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. | Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively. | Posted | Mean | Standard Deviation | units on a scale | Pre-op, Month 1, Month 6, 1 year |
|
|
|
| Secondary | Hernia Recurrence | Posted | Number | participants | Discharge, 1 Month, 6 Month, 1 year |
|
|
|
| 6 |
| 53 |
| 17 |
| 53 |
| EG001 | Inguinal Arm - ProTack | Inguinal hernia study arm with ProTack as treatment. | 6 | 51 | 20 | 51 |
| EG002 | Ventral Arm - Absorbatack | Ventral hernia study arm with AbsorbaTack as treatment. | 8 | 55 | 24 | 55 |
| EG003 | Ventral Arm - ProTack | Ventral hernia study arm with ProTack as treatment. | 9 | 54 | 33 | 54 |
| Dysphagia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| GI hemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hernia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Oesophagectomy | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal laminectomy | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Adrenocortical Insufficiency Acute | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Suture Related Complication | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Kidney transplant rejection | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Laparotomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Prostatectomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| 1 Month |
|
| 6 Month |
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| 1 year |
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| 1 Month |
|
| 6 Month |
|
| 1 Year |
|