Tension in Posterior Component Separation for Abdominal Wall Reconstruction

Ventral Incisional Hernia Clinical Trial

Official title:

Quantitative Tension in Posterior Component Separation for Abdominal Wall Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142761
• Other study ID #: 21-1034
• Status: Completed
• Start date: December 2, 2021
• Est. completion date: September 2, 2022

Study information

• Verified date: March 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidates for abdominal wall reconstruction

• Patients able to provide informed consent

Exclusion Criteria:

• Patients unable to provide informed consent

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Ventral Incisional Hernia

Locations

Country	Name	City	State
United States	Cleveland Clinic Comprehensive Hernia Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Michael Rosen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tension changes in posterior component separation	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.	Tension measurements will be recorded immediately during surgery
Secondary	Wound Morbidity		30 days after surgery
Secondary	Readmission	Readmission to the hospital	30 days after surgery
Secondary	Reoperation	Reoperation on abdominal wall reconstruction	30 days after surgery
Secondary	Ileus	Number of Ileus events in study subjects	30 days after surgery
Secondary	Pulmonary complications	Number of pulmonary complications in study subjects	30 days after surgery
Secondary	Short term hernia recurrences	Recurrence of hernia following study procedures	30 days