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Active, Not Recruiting

NCT Number: NCT06051578

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HERNIA, VENTRAL Hernia Hernia Abdominal Wall Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Abdominal wall tension measurement

Other

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

Primary outcomes

  1. Abdominal wall tension in patients hernia repair without component separation

    Time frame: 2 year

    The abdominal wall tension prior to closure will be measured

Secondary outcomes

  1. Patient factors that contribute to greater abdominal wall tension

    Time frame: 2 year

    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. Association between abdominal wall tension and patient outcomes

    Time frame: 2 year

    Abdominal wall tension will be determined and patient outcomes will be analyzed including complications, wound morbidity, recurrence

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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