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

NCT ID: NCT02321059

Last Updated: 2015-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Incisional Hernia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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No incisional hernia group

Healthy volunteers with an intact abdominal wall.

Measurement of abdominal wall strength

Intervention Type DEVICE

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

Incisional hernia group

Patients with a ventral incisional hernia.

Measurement of abdominal wall strength

Intervention Type DEVICE

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

Interventions

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Measurement of abdominal wall strength

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristian Kiim Jensen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristian K Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen NV, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-1-2014-008

Identifier Type: -

Identifier Source: org_study_id

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