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Interoperability issue between necessary devices.
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This is a prospective cohort study. Patients have an incisional or parastomal hernia with >20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal wall tension | Device | Abdominal wall tension measurement All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer." |
| |
| Intra-abdominal pressure | Device | Intra-abdominal pressure All patients will have their intra-abdominal pressure continuously monitored using Sentinel's FDA approved TraumaGuard catheter, a pressure-sensing urinary catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications | Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Post-operative complications measured in proportion of events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs) | Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs) | 1 year |
| Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with an incisional or parastomal hernia with a >20 cm fascial defect on pre-operative imaging who undergo an anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement will be included. The investigators anticipate that patients with very large defects will experience the greatest changes in abdominal wall tension and intra-abdominal pressure.
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin T Miller, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| 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 |
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Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs) Hernia defect size (length and width in cm) |
| 1 year |
| Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O) | Intra-abdominal pressure using TraumaGuard catheter in mmHg Abdominal wall tension measured using tensiometer in pounds Airway pressure measured on mechanical ventilator in cmH2O | 1 year |
| Temporal changes in renal function (serum Creatinine) | Creatinine reported on routine laboratory blood work (comprehensive metabolic panel) measured over time | 1 year |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |