Incisional Hernia, Parastomal Hernia, Ventral Hernia
Conditions
Brief summary
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.
Interventions
DEVICEAbdominal wall tension
Abdominal wall tension measurement All patients will have the tension of their abdominal wall measured during surgery using a tension scale or tensiometer.
DEVICEIntra-abdominal pressure
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.
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients ≥ 18 years of age * Incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging * Anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement
Exclusion criteria
* Pregnant patients * Require a Legally Authorized Representative (LAR) to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications | 1 year | Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Post-operative complications measured in proportion of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs) | 1 year | Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Abdominal wall tension measured using tensiometer in pounds (lbs) |
| Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm) | 1 year | 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) |
| Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O) | 1 year | Intra-abdominal pressure using TraumaGuard catheter in mmHg Abdominal wall tension measured using tensiometer in pounds Airway pressure measured on mechanical ventilator in cmH2O |
| Temporal changes in renal function (serum Creatinine) | 1 year | Creatinine reported on routine laboratory blood work (comprehensive metabolic panel) measured over time |
Countries
United States
Outcome results
None listed