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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06051578
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Benjamin T. Miller, The Cleveland Clinic

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. 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.


Condition or disease Intervention/treatment
Hernia, Ventral Hernia, Abdominal Hernia Abdominal Wall 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
Actual Study Start Date : September 8, 2023
Estimated Primary Completion Date : September 8, 2025
Estimated Study Completion Date : September 8, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia


Intervention Details:
  • Other: Abdominal wall tension measurement
    All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051578


Contacts
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Contact: Benjamin Miller, MD 2164068573 millerb35@ccf.org
Contact: Daphne Remulla, MD 2163997047 remulld@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Benjamin Miller, MD    216-406-8573    millerb35@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Benjamin Miller, MD The Cleveland Clinic
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Responsible Party: Benjamin T. Miller, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT06051578    
Other Study ID Numbers: 23-857
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Hernia, Abdominal
Internal Hernia
Pathological Conditions, Anatomical