NCT06051578

Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation. 1. What is the abdominal wall tension for hernias repaired without a component separation? 2. What patient factors contribute to greater abdominal wall tension? 3. Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes? Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.

Detailed description

This is a prospective cohort study. Patients who undergo hernia repair without component separation will have their abdominal wall tension measured using a tension scale. The scale is an investigational (experimental) device that works by attaching to surgical clamps during surgery to measure the tension on the abdominal wall. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.

Conditions

• Hernia, Ventral
• Hernia, Abdominal
• Hernia Abdominal Wall

Interventions

Type	Name	Description
OTHER	Abdominal wall tension measurement	All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."

Timeline

• Start date: 2023-09-08
• Primary completion: 2025-05-22
• Completion: 2026-05-01
• First posted: 2023-09-25
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States