ClinicalTrials.gg
Active, not recruitingNCT06051578Updated Aug 4, 2026

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

An observational study in Hernia, Ventral, Hernia, Abdominal and Hernia Abdominal Wall, sponsored by The Cleveland Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hernia, Ventral
  • Hernia, Abdominal
  • Hernia Abdominal Wall
03

In context

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's planned enrollment of 50 is below the median of 132 across 65 observational studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • OtherAbdominal wall tension measurement

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

06

What researchers measure

Primary outcomes

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

    The abdominal wall tension prior to closure will be measured

    Time frame: 2 year

Secondary outcomes

  1. 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.

    Time frame: 2 year

  2. 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

    Time frame: 2 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for May 2027, 44 months after the start.

Of 20 observational studies under Hernia, Ventral, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 72. This study's planned 44 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2023
First posted
Sep 25, 2023
StartActual
Sep 8, 2023
Primary completionEst.
May 22, 2027
CompletionEst.
Jul 1, 2027
Last update
Aug 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06051578
Responsible party
Benjamin T. Miller (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Sep 25, 2023
Start date
Sep 8, 2023
Primary completion
May 22, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Aug 4, 2026

Study contacts

Benjamin Miller, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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