Clinical trial NCT05579652: Change in Fascial Tension in Open Abdomens
Official title: The Change in Tension of the Abdominal Wall Tension in Open Abdomens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Wall Defect
Incisional Hernia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients with an open abdomen and plan for abdominal re-exploration

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in tension over time
timeFrame: 1.5 years
Secondary outcomes:
measure: Subject factors affecting abdominal wall tension over time
timeFrame: 1.5 years
measure: Operative factors affecting abdominal wall tension over time
timeFrame: 1.5 years
measure: Medical care factors affecting abdominal wall tension over time
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Benjamin Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: