Skip to main content
OpenTrials
Completed

NCT Number: NCT05142761

Tension in Posterior Component Separation for Abdominal Wall Reconstruction

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Comprehensive Hernia Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidates for abdominal wall reconstruction
  • Patients able to provide informed consent

Exclusion criteria

  • Patients unable to provide informed consent

Treatment and study plan

Primary outcomes

  1. Tension changes in posterior component separation

    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.

Secondary outcomes

  1. Wound Morbidity

    Time frame: 30 days after surgery

  2. Readmission

    Time frame: 30 days after surgery

    Readmission to the hospital

  3. Reoperation

    Time frame: 30 days after surgery

    Reoperation on abdominal wall reconstruction

  4. Ileus

    Time frame: 30 days after surgery

    Number of Ileus events in study subjects

  5. Pulmonary complications

    Time frame: 30 days after surgery

    Number of pulmonary complications in study subjects

  6. Short term hernia recurrences

    Time frame: 30 days

    Recurrence of hernia following study procedures

Sponsors and collaborators

Lead sponsor

Michael Rosen

Other

Registry information

Official study title

Quantitative Tension in Posterior Component Separation for Abdominal Wall Reconstruction

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2021
Registry last updated
Mar 30, 2023

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.