Hernia, VentralNCT06051578
Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
An observational study of Hernia, Ventral and Hernia, Abdominal, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
- What is being tested?
- Abdominal wall tension measurement
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 1 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients who are planned to undergo ventral hernia repair without component separation
- Midline hernia
Who cannot join
- Mesh excision for reasons other than mesh infection
- Prior component separation
- Isolated flank hernia
- Patients under the age of 18 years
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
- What is the abdominal wall tension for hernias repaired without a component separation?
- What patient factors contribute to greater abdominal wall tension?
- 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.
Read the 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
- Being tested
- Abdominal wall tension measurement
- Medical subject headings
- Hernia, Ventral, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal wall tension measurementOther
All patients will have the tension of their abdominal wall measured during surgery using a tension scale or "tensiometer."
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall tension in patients hernia repair without component separation
The abdominal wall tension prior to closure will be measured
Measured: 2 year
Secondary outcomes (2)
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.
Measured: 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
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start8 Sep 2023
- Primary completion22 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin T. Miller, The Cleveland Clinic
- Investigators
- Benjamin Miller, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051578
- Sponsor's protocol ID
- 23-857
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No