Tension in Posterior Component Separation for Abdominal Wall Reconstruction
- Conditions
- Ventral Incisional Hernia
- Registration Number
- NCT05142761
- Lead Sponsor
- Michael Rosen
- Brief Summary
The purpose of this study is to measure the changes in tension after each release in a standard posterior component separation during abdominal wall reconstruction.
- Detailed Description
Myofascial component separation techniques are purported to reduce tension in abdominal wall reconstruction, but few objective data exist regarding tension reduction with posterior component separation (PCS) techniques. PCS techniques include several unique steps: division of the posterior rectus sheath, division of the posterior lamella of the internal oblique aponeurosis, and transversus abdominis release. Each of these releases carries a certain amount of morbidity, including neurovascular injuries, posterior sheath breakdowns, and musculofascial disruptions resulting in lateral hernias, and thus should only be undertaken if necessary to achieve physiologic tension. More importantly, during a PCS, the surgeon must achieve posterior elements apposition in the midline to allow an adequate pocket to deploy the mesh and avoid breakdown and interstitial hernias and recurrences. Further, the anterior sheath should be reapproximated to complete a functional abdominal wall reconstruction. During each procedure, the surgeon must assess the tension on the posterior closure and decide whether further release is necessary to achieve a safe, durable repair of the posterior elements.
Demographic information, including patient age, gender, BMI, history of diabetes, chronic immunosuppression, smoking history, and history of prior ventral hernia repairs will be captured in the Abdominal Core Health Quality Collaborative (ACHQC), per the investigators' practice standard. Additional intraoperative information collected will be hernia size, extent of posterior component separation, mesh size and type, and location of mesh placement. The ACHQC is a hernia-specific, nationwide registry for quality improvement, featuring prospectively-collected, surgeon-entered data.
The aim of this study is to determine the changes in abdominal wall tension with progressive PCS in abdominal wall reconstruction. The investigators also aim to quantify the reduction in tension on both the anterior and posterior elements of a PCS.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Candidates for abdominal wall reconstruction
- Patients able to provide informed consent
- Patients unable to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tension changes in posterior component separation Tension measurements will be recorded immediately during surgery The tension required to bring the anterior and posterior elements of the abdominal wall to the midline after each step of the posterior component separation will be measured with a scale designed by Cleveland Clinic Mechanical Prototype machinists. The scale, hooked to a clamp on the edge of the abdominal wall, will measure tension in pounds.
- Secondary Outcome Measures
Name Time Method Short term hernia recurrences 30 days Recurrence of hernia following study procedures
Ileus 30 days after surgery Number of Ileus events in study subjects
Pulmonary complications 30 days after surgery Number of pulmonary complications in study subjects
Wound Morbidity 30 days after surgery Reoperation 30 days after surgery Reoperation on abdominal wall reconstruction
Readmission 30 days after surgery Readmission to the hospital
Trial Locations
- Locations (1)
Cleveland Clinic Comprehensive Hernia Center
🇺🇸Cleveland, Ohio, United States