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

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.

Study Overview

• Status: Recruiting
• Conditions: Hernia, Abdominal; Hernia, Ventral; Hernia Abdominal Wall
• Intervention / Treatment: Other: Abdominal wall tension measurement

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Benjamin Miller, MD; Phone Number: 2164068573; Email: millerb35@ccf.org
• Study Contact Backup: Name: Daphne Remulla, MD; Phone Number: 2163997047; Email: remulld@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Benjamin Miller, MD; Phone Number: 216-406-8573; Email: millerb35@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

1. Patients who are planned to undergo ventral hernia repair without component separation
2. Midline hernia

Exclusion Criteria:

1. Mesh excision for reasons other than mesh infection
2. Prior component separation
3. Isolated flank hernia
4. Patients under the age of 18 years
5. Pregnant patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal wall tension in patients hernia repair without component separation	The abdominal wall tension prior to closure will be measured	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient factors that contribute to greater abdominal wall tension	Patient demographics, comorbidities, operative history, operative details, hernia size and width and abdominal wall tension will be collected and analyzed to determine what factors contribute to abdominal wall tension.	2 year
Association between abdominal wall tension and patient outcomes	Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence	2 year

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Benjamin Miller, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): September 8, 2025
• Study Completion (Estimated): September 8, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: 23-857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No