Cleveland Clinic Comprehensive Hernia Center
Cleveland, Ohio, 44195, United States
NCT Number: NCT05142761
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 30 days after surgery
Time frame: 30 days after surgery
Readmission to the hospital
Time frame: 30 days after surgery
Reoperation on abdominal wall reconstruction
Time frame: 30 days after surgery
Number of Ileus events in study subjects
Time frame: 30 days after surgery
Number of pulmonary complications in study subjects
Time frame: 30 days
Recurrence of hernia following study procedures
Michael Rosen
Other
Quantitative Tension in Posterior Component Separation for Abdominal Wall Reconstruction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02206828
Hernia, Pathological Conditions, Anatomical
Montrouge, France
View Trial DetailsNCT02129140
Ventral Incisional Hernia
New York, United States
View Trial DetailsNCT03043079
Ventral Incisional Hernia
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT01325792
Ventral Incisional Hernia
San Diego, California, United States
View Trial Details