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

NCT02321059 | Completed DMC

• 1 other identifier: H-1-2014-008
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia

Keywords

incisional hernia; hernia; abdominal wall strength; validation; physical activity

Outcome Measures

Primary Outcomes (1)

• Abdominal wall strength measured by the Goodstrength system

  Change in abdominal wall strength from baseline to follow-up.

  One week

Secondary Outcomes (3)

• Physical activity the last week, assessed by the International Physical Activity Questionnaire

  Once, at baseline examination

• Self-assessed abdominal wall strength, as measured on a visual analogue scale

  Once, at baseline examination

• Trunk extensor strength measured by the Goodstrength system

  One week

Study Arms (2)

No incisional hernia group

Healthy volunteers with an intact abdominal wall.

Device: Measurement of abdominal wall strength

Incisional hernia group

Patients with a ventral incisional hernia.

Device: Measurement of abdominal wall strength

Interventions

Measurement of abdominal wall strength DEVICE

Test-retest examination of the reliability of the Goodstrength trunk dynamometer

Incisional hernia group; No incisional hernia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on waiting list for repair of a ventral incisional hernia and healthy volunteers.

You may qualify if:

• American Society of Anesthesiologists score 1-3
• Age equal to or above 18
• Ventral incisional hernia OR intact abdominal wall

You may not qualify if:

• Pregnancy
• Severe heart disease (New York Heart Association class III-IV)
• Severe pulmonary disease
• Severe musculoskeletal disease
• Systemic treatment with glucocorticoid

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Incisional Hernia; Hernia; Motor Activity

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Behavior

Study Officials

• Kristian K Jensen, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: December 22, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

DK (1)