Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia

Incisional Hernia Clinical Trial

— VAGSI  

Official title:

Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321059
• Other study ID #: H-1-2014-008
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: June 25, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists score 1-3

• Age equal to or above 18

• Ventral incisional hernia OR intact abdominal wall

Exclusion Criteria:

• Pregnancy

• Severe heart disease (New York Heart Association class III-IV)

• Severe pulmonary disease

• Severe musculoskeletal disease

• Systemic treatment with glucocorticoid

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Device:
• Measurement of abdominal wall strength
Test-retest examination of the reliability of the Goodstrength trunk dynamometer

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal wall strength measured by the Goodstrength system	Change in abdominal wall strength from baseline to follow-up.	One week	No
Secondary	Physical activity the last week, assessed by the International Physical Activity Questionnaire		Once, at baseline examination	No
Secondary	Self-assessed abdominal wall strength, as measured on a visual analogue scale		Once, at baseline examination	No
Secondary	Trunk extensor strength measured by the Goodstrength system	Change in trunk extensor strength from baseline to follow-up.	One week	No