Abdominal Wall DefectNCT05579652
Change in Fascial Tension in Open Abdomens
An observational study of Abdominal Wall Defect and Incisional Hernia, run by Benjamin T. Miller at 1 site in United States.
Trial summary
The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Wall Defect, Incisional Hernia
- What is being tested?
- Abdominal tension measurement
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 29 Mar 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 investigators will identify patients with an open abdomen following laparotomy with plans to return to the operating room for re-exploration. Previous laparotomy, presence of a stoma, and presence of a previous hernia repair without component separation will not exclude patients from this study.
Who may be able to join
- Adult patients with an open abdomen and plan for abdominal re-exploration
Who cannot join
- patients under the age of 18 years
- pregnant patients
- patients who have no available Legally Authorized Representative to provide consent.
- patients with a current hernia
- patients with a prior component separation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Change in Tension of the Abdominal Wall Tension in Open Abdomens
The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.
Read the detailed description
For subjects undergoing damage control and decompressive laparotomy, surgeons frequently elect to keep the abdomen open in anticipation of multiple re-explorations or to prevent and/or treat abdominal compartment syndrome. The eventual goal is to definitively close the abdomen, including the fascia, when medically and surgically safe. The natural tendency with prolonged open abdomen is lateralization of the fascia, making closure of the fascia progressively more difficult as time passes. Though this is subjectively observed in the operating room as increased tension during fascial closure, there is no quantitative data describing how duration of open abdomen affects tension on the abdominal wall. This information has potential implications on the likelihood of successful primary closure, risk of dehiscence, and long term hernia development. This study aims to quantitatively measure the changes in tension of the abdominal wall over time in subjects with an open abdomen. A tensiometer will be used to measure the tension needed to approximate each side of the abdominal fascia to midline with each re-exploration until definitive abdominal wall closure.
- Conditions
- Abdominal Wall Defect, Incisional Hernia
- Being tested
- Abdominal tension measurement
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal tension measurementDiagnostic test
A tensiometer scale will be used to measure the tension needed to pull each side of the abdominal wall to midline
| Study group | Role | What they receive |
|---|---|---|
| Patients with open abdomen | All non-pregnant adults with an open abdomen who are consentable or who have a legally authorized representative will have the tension on each side of their abdominal wall measured using a tensiometer at each abdominal exploration Receives: Diagnostic Test: Abdominal tension measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tension over time
The progressive change in abdominal wall tension will be analyzed
Measured: 1.5 years
Secondary outcomes (3)
Subject factors affecting abdominal wall tension over time
Investigators will evaluate the relationship of BMI and age to the change in tension over time
Measured: 1.5 years
Operative factors affecting abdominal wall tension over time
Investigators will evaluate the relationship of incision width and length, time in days that the abdomen was open, number of reoperations, and abdominal wall tension change over time.
Measured: 1.5 years
Medical care factors affecting abdominal wall tension over time
Investigators will evaluate the relationship of volume and type of intravenous fluid administered, blood transfusion, diuresis, and vasopressor use and the change in abdominal wall tension over time.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start17 Oct 2022
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall DefectStudies of the same condition, open and under way.
- 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
- 45 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Benjamin T. Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin T. Miller, The Cleveland Clinic
- Investigators
- Benjamin Miller, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579652
- Sponsor's protocol ID
- 22-845
- Status last verified
- May 2024
- First submitted
- 11 Oct 2022
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change in Tension of the Abdominal Wall Tension in Open Abdomens
- ClinicalTrials.gov ID
- NCT05579652
- Acronym / sponsor ID
- 22-845
- Conditions
- Abdominal Wall Defect, Incisional Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Benjamin T. MillerUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.
Detailed description
For subjects undergoing damage control and decompressive laparotomy, surgeons frequently elect to keep the abdomen open in anticipation of multiple re-explorations or to prevent and/or treat abdominal compartment syndrome. The eventual goal is to definitively close the abdomen, including the fascia, when medically and surgically safe. The natural tendency with prolonged open abdomen is lateralization of the fascia, making closure of the fascia progressively more difficult as time passes. Though this is subjectively observed in the operating room as increased tension during fascial closure, there is no quantitative data describing how duration of open abdomen affects tension on the abdominal wall. This information has potential implications on the likelihood of successful primary closure, risk of dehiscence, and long term hernia development. This study aims to quantitatively measure the changes in tension of the abdominal wall over time in subjects with an open abdomen. A tensiometer will be used to measure the tension needed to approximate each side of the abdominal fascia to midline with each re-exploration until definitive abdominal wall closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with open abdomen | – | Diagnostic Test: Abdominal tension measurementAll non-pregnant adults with an open abdomen who are consentable or who have a legally authorized representative will have the tension on each side of their abdominal wall measured using a tensiometer at each abdominal exploration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will identify patients with an open abdomen following laparotomy with plans to return to the operating room for re-exploration. Previous laparotomy, presence of a stoma, and presence of a previous hernia repair without component separation will not exclude patients from this study.
Key inclusion criteria (1 listed)
- Adult patients with an open abdomen and plan for abdominal re-exploration
Key exclusion criteria (5 listed)
- patients under the age of 18 years
- pregnant patients
- patients who have no available Legally Authorized Representative to provide consent.
- patients with a current hernia
- patients with a prior component separation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal tension measurementA tensiometer scale will be used to measure the tension needed to pull each side of the abdominal wall to midline | Diagnostic test | Patients with open abdomen |
Primary outcome
Change in tension over time
Time frame: 1.5 years
The progressive change in abdominal wall tension will be analyzed
3 secondary outcomes
Subject factors affecting abdominal wall tension over time
Time frame: 1.5 years
Operative factors affecting abdominal wall tension over time
Time frame: 1.5 years
Medical care factors affecting abdominal wall tension over time
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Miller, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wall Defect and Incisional Hernia, run by Benjamin T. Miller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tension over time (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.