Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05142761
Study type Observational [Patient Registry]
Source The Cleveland Clinic
Contact
Status Completed
Phase
Start date December 2, 2021
Completion date September 2, 2022

See also
  Status Clinical Trial Phase
Terminated NCT03034213 - Gentrix™ Versus Biological or Prosthetic Mesh N/A
Enrolling by invitation NCT06306976 - Shear-Wave Elastography N/A
Not yet recruiting NCT06183840 - Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair N/A
Completed NCT02206828 - The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair
Not yet recruiting NCT04624100 - Quality Control of Ventral Hernia Surgery by Prospective Registration
Active, not recruiting NCT03324854 - Use of Mosquito Net Mesh for Ventral Hernia Repair N/A
Not yet recruiting NCT05575141 - Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias N/A
Completed NCT01325792 - Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement N/A
Terminated NCT03317665 - Observational Biologic or Prosthetic Mesh
Recruiting NCT05576753 - Preperitoneal Umbilical Mesh Area N/A
Recruiting NCT03255239 - Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias N/A
Completed NCT03043079 - Ultrasound Assessment of Ventral Hernia Defects N/A
Completed NCT02129140 - Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)