Trial Outcomes & Findings for Ultrasound Assessment of Ventral Hernia Defects (NCT NCT03043079)

NCT ID: NCT03043079

Last Updated: 2020-03-24

Results Overview

Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: study intiation ultrasound scan lasting up to 45 minutes
• Results posted on: 2020-03-24

Participant Flow

Participant milestones

Measure	Ventral Hernia Twenty-One patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Healthy Volunteers Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Active Health Volunteers Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Overall Study STARTED	21	14	10
Overall Study COMPLETED	21	14	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Assessment of Ventral Hernia Defects

Baseline characteristics by cohort

Measure	Ventral Hernia n=21 Participants Twenty-one patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Healthy Volunteers n=14 Participants Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Active Health Volunteers n=10 Participants Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	38 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Age, Continuous	58.3 years STANDARD_DEVIATION 7.9 • n=5 Participants	60.5 years STANDARD_DEVIATION 5.4 • n=7 Participants	27.0 years STANDARD_DEVIATION 3.17 • n=5 Participants	48.6 years STANDARD_DEVIATION 14.7 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	14 participants n=7 Participants	10 participants n=5 Participants	45 participants n=4 Participants
9L4 No Pressure External Oblique Shear Wave Velocity	1.94 meters per second n=5 Participants	1.9 meters per second n=7 Participants	1.97 meters per second n=5 Participants	1.9 meters per second n=4 Participants

PRIMARY outcome

Timeframe: study intiation ultrasound scan lasting up to 45 minutes

Population: 21 ventral hernia age and BMI matched to 14 health volunteers with 10 active volunteers

Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients

Outcome measures

Measure	Ventral Hernia n=21 Participants Twenty-one patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Healthy Volunteers n=14 Participants Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Active Health Volunteers n=10 Participants Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall	1.89 meters per second Standard Deviation .31	1.92 meters per second Standard Deviation .46	1.89 meters per second Standard Deviation .13

SECONDARY outcome

Timeframe: through study completion, an up to 26 weeks postoperative

Differences in the shear wave velocity measurements in the abdominal wall of preoperative hernia scan and postoperative scan 26 weeks after surgical ventral hernia repair

Outcome measures

Measure	Ventral Hernia n=21 Participants Twenty-one patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Healthy Volunteers Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Active Health Volunteers Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair	1.726 meters per second Standard Deviation 0.36	—	—

SECONDARY outcome

Timeframe: 1 year

Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging

Outcome measures

Measure	Ventral Hernia n=21 Participants Twenty-one patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Healthy Volunteers Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)	Active Health Volunteers Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
Incidental Findings and Ultrasound Safety	0 Participants	—	—

Adverse Events

Ventral Hernia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Health Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ventral Hernia n=24 participants at risk Twenty-one patients diagnosed with ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) No adverse events Related to study	Healthy Volunteers n=14 participants at risk Fourteen volunteers without ventral hernia Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) No adverse events Related to study	Active Health Volunteers n=10 participants at risk Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) No adverse events Related to study
Investigations Incidental Finding	0.00% 0/24 • Hernia patients were followed for adverse events for an average of 12 months. There were seen in the outpatuent clinic following typical standard of care guidelines, which is typically 2 weeks and 3 months. Healthy and active volunteers were followed during the initial ultrasound, up to 45 minutes. Adverse events were defined as any event that harmed subjects related to the study protocol. Adverse events related to the hernia surgery itself were not included in the study adverse events as the surgery plan was not affected by study participation. All subjects got the same surgical care that they would have if they were not enrolled in the study.	0.00% 0/14 • Hernia patients were followed for adverse events for an average of 12 months. There were seen in the outpatuent clinic following typical standard of care guidelines, which is typically 2 weeks and 3 months. Healthy and active volunteers were followed during the initial ultrasound, up to 45 minutes. Adverse events were defined as any event that harmed subjects related to the study protocol. Adverse events related to the hernia surgery itself were not included in the study adverse events as the surgery plan was not affected by study participation. All subjects got the same surgical care that they would have if they were not enrolled in the study.	0.00% 0/10 • Hernia patients were followed for adverse events for an average of 12 months. There were seen in the outpatuent clinic following typical standard of care guidelines, which is typically 2 weeks and 3 months. Healthy and active volunteers were followed during the initial ultrasound, up to 45 minutes. Adverse events were defined as any event that harmed subjects related to the study protocol. Adverse events related to the hernia surgery itself were not included in the study adverse events as the surgery plan was not affected by study participation. All subjects got the same surgical care that they would have if they were not enrolled in the study.

Additional Information

Dr. John P Fischer

University of Pennsylvania

Phone: 2156627300

Email: john.fischer2@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place