Change in Fascial Tension in Open Abdomens

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Wall Defect; Incisional Hernia
• Intervention / Treatment: Diagnostic test: Abdominal tension measurement

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Abdominal tension measurement; A tensiometer scale will be used to measure the tension needed to pull each side of the abdominal wall to midline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tension over time	The progressive change in abdominal wall tension will be analyzed	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject factors affecting abdominal wall tension over time	Investigators will evaluate the relationship of BMI and age to the change in tension over time	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.	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.	1.5 years

Collaborators and Investigators

• Sponsor: Benjamin T. Miller
• Investigators: Principal Investigator: Benjamin Miller, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 22-845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No