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

NCT06051578 | Active Not Recruiting

• 1 other identifier: 23-857
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.What is the abdominal wall tension for hernias repaired without a component separation?
2. 2.What patient factors contribute to greater abdominal wall tension?
3. 3.Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes?

Conditions

Hernia, Ventral; Hernia, Abdominal; Hernia Abdominal Wall

Outcome Measures

Primary Outcomes (1)

• Abdominal wall tension in patients hernia repair without component separation

  The abdominal wall tension prior to closure will be measured

  2 year

Secondary Outcomes (2)

• Patient factors that contribute to greater abdominal wall tension

  2 year

• Association between abdominal wall tension and patient outcomes

  2 year

Interventions

Abdominal wall tension measurement OTHER

All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 50 patients who have been evaluated by a surgeon and will undergo a hernia repair without component separation.

You may qualify if:

• Patients who are planned to undergo ventral hernia repair without component separation
• Midline hernia

You may not qualify if:

• Mesh excision for reasons other than mesh infection
• Prior component separation
• Isolated flank hernia
• Patients under the age of 18 years
• Pregnant patients

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin Miller, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: September 8, 2023
• Primary Completion: May 22, 2025
• Study Completion: May 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)