Hernia, Abdominal, Hernia Abdominal Wall, Hernia, Ventral
Conditions
Brief summary
The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation. 1. What is the abdominal wall tension for hernias repaired without a component separation? 2. What patient factors contribute to greater abdominal wall tension? 3. Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes? Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.
Detailed description
This is a prospective cohort study. Patients who undergo hernia repair without component separation will have their abdominal wall tension measured using a tension scale. The scale is an investigational (experimental) device that works by attaching to surgical clamps during surgery to measure the tension on the abdominal wall. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.
Interventions
OTHERAbdominal wall tension measurement
All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."
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
1. Patients who are planned to undergo ventral hernia repair without component separation 2. Midline hernia
Exclusion criteria
1. Mesh excision for reasons other than mesh infection 2. Prior component separation 3. Isolated flank hernia 4. Patients under the age of 18 years 5. Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal wall tension in patients hernia repair without component separation | 2 year | The abdominal wall tension prior to closure will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient factors that contribute to greater abdominal wall tension | 2 year | Patient demographics, comorbidities, operative history, operative details, hernia size and width and abdominal wall tension will be collected and analyzed to determine what factors contribute to abdominal wall tension. |
| Association between abdominal wall tension and patient outcomes | 2 year | Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Miller, MD
The Cleveland Clinic
Outcome results
None listed