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This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.
The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepramesh Group |
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| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. | A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure. | 12 months or greater (average follow-up time of 3 years; range 13-65 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Complications in Subjects With Hernias Repaired With Sepramesh. | Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination). | 12 months or greater (average follow-up time of 3 years; range 13-65 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have been treated with Sepramesh at least 12 months before starting in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew L Archer, MD | Providence Medical Group and Cornerstone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Medical Center | Centerville | Ohio | 45459 | United States |
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Between October 2010 and February 2011, a total of 90 subjects were enrolled at a single study site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sepramesh Group | Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sepramesh Group | Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment. |
| 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 | Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. | A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure. | All enrolled subjects were included in the analysis. | Posted | Number | participants | 12 months or greater (average follow-up time of 3 years; range 13-65 months) |
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|
Protocol defined adverse events were collected for a period of 12 months or greater, with the collection period beginning at the time of the index procedure and ending at the time of the subject's last study contact.
Adverse events (or complications) were defined as any undesirable clinical event occurring in the abdominal skin, abdominal wall, involving abdominal organs and/or any other event judged to be related to the surgical procedure of Sepramesh Composite.
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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 | Sepramesh Group | Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (12.0) | This event is the hernia recurrence identified in the primary outcome analysis. It was reported approximately 14 months after the hernia repair procedure. Event was reported as serious but mild and possibly related to the hernia repair procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (12.0) |
Study was designed to use existing data. Limitations include: limited data generalizability given the retrospective, single center study design; incomplete documentation did not permit evaluation of recovery time as pre-specified secondary endpoint.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer/Director, Clinical Affairs | C.R. Bard: Davol, Inc. | 401-825-8681 | dawn.heimer@crbard.com |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Procedural Time for Sepramesh Placement. | Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin). | Day 0 |
| Recovery Time Associated With Hernias Repaired With Sepramesh. | Recovery time will be defined as the time it took for the subject to return to work. | 12 months or greater (average follow-up time of 3 years; range 13-65 months) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| Height | Mean | Standard Deviation | centimeters |
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| Body Mass Index | Mean | Standard Deviation | kilograms per square meter |
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| Hernia Classification | Type of hernia subject had repaired during the index procedure: umbilical, incisional, or umbilical and incisional. | Number | participants |
|
| Participants |
|
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| Secondary | Complications in Subjects With Hernias Repaired With Sepramesh. | Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination). | All enrolled subjects were included in the analysis. | Posted | Number | participants | 12 months or greater (average follow-up time of 3 years; range 13-65 months) |
|
|
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| Secondary | Procedural Time for Sepramesh Placement. | Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin). | All enrolled subjects were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Day 0 |
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| Secondary | Recovery Time Associated With Hernias Repaired With Sepramesh. | Recovery time will be defined as the time it took for the subject to return to work. | Data not available: none of the subject medical records reported return to work data. Secondary endpoint analysis could not be performed. | Posted | 12 months or greater (average follow-up time of 3 years; range 13-65 months) |
|
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| Post-Hoc | Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh. | A recurrent incisional hernia is an incisional hernia, confirmed by the Investigator at any point after the surgery, in the same location as the incisional hernia that was repaired in the index procedure. | The analysis population included the 42 subjects who underwent surgery to repair incisional hernias in the index procedure. | Posted | Number | participants | 12 months or greater |
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| Post-Hoc | Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh. | A recurrent umbilical hernia is an umbilical hernia, confirmed by the Investigator at any point after the surgery, in the same location as the umbilical hernia that was repaired in the index procedure. | The analysis population included the 43 subjects who underwent surgery to repair umbilical hernias in the index procedure. | Posted | Number | participants | 12 months or greater |
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| Post-Hoc | Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias | A recurrent hernia is a hernia (either umbilical or incisional), confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure. | This analysis included the 5 subjects who underwent surgery to repair both incisional and umbilical hernias in the index procedure. | Posted | Number | participants | 12 months or greater |
|
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| 3 |
| 90 |
| 1 |
| 90 |
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| Seroma | Injury, poisoning and procedural complications | MedDRA (12.0) | Postoperative seroma reported following a procedure which was unrelated to both the study device or procedure. Event was reported as serious but mild and unrelated to both the device and the procedure. |
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| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA (12.0) | Subject developed a new (non-study) hernia at an instrument insertion site used during the procedure to repair the study hernia. Event was reported as serious but mild, unrelated to the device and definitely related to the procedure. |
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