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

Completed

• Conditions: Incisional Hernia
• Interventions: Device: Measurement of abdominal wall strength

• Registration Number: NCT02321059
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-22
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No incisional hernia group	Measurement of abdominal wall strength	Healthy volunteers with an intact abdominal wall.
Incisional hernia group	Measurement of abdominal wall strength	Patients with a ventral incisional hernia.

Primary Outcome Measures

Name	Time	Method
Abdominal wall strength measured by the Goodstrength system	One week	Change in abdominal wall strength from baseline to follow-up.

Secondary Outcome Measures

Name	Time	Method
Physical activity the last week, assessed by the International Physical Activity Questionnaire	Once, at baseline examination
Trunk extensor strength measured by the Goodstrength system	One week	Change in trunk extensor strength from baseline to follow-up.
Self-assessed abdominal wall strength, as measured on a visual analogue scale	Once, at baseline examination

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Copenhagen, Denmark