- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06306976
Predicting Fascial Closure in Midline Incisional Hernias Using Shear-Wave Elastography
This clinical trial investigates the use of shear-wave elastography (SWE) as a predictive tool for fascial closure in patients with midline incisional hernias. The study aims to assess abdominal wall muscle elasticity preoperatively and correlate these measurements with surgical outcomes. By evaluating the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles, researchers hope to improve surgical planning and reduce complications.
Study Objectives:
- Measure abdominal wall muscle elasticity using SWE in patients with varying hernia complexities.
- Correlate SWE findings with the extent of myofascial release (MFR) required for fascial closure.
- Compare SWE results with intraoperative tension measurements using a spring-tensiometer.
Methodology:
The study includes 70 participants divided into three groups: patients with midline incisional hernias (study group) and two control groups (healthy volunteers and patients undergoing elective midline laparotomy). All participants will undergo ultrasound imaging with SWE, while the study group and one control group will also receive surgical intervention.
Key Procedures:
- Ultrasound imaging with SWE at specific abdominal landmarks
- Open retromuscular hernia repair with mesh reinforcement for study patients
- Tensiometry during surgery to measure closure tension
Potential Impact:
This research could revolutionize preoperative planning for hernia repairs by providing objective measurements of abdominal wall compliance. If successful, SWE may become a standard tool for predicting surgical outcomes and tailoring operative approaches to individual patient anatomy.
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