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Midline restoration after HYbriD incisional hernia RepAir (HYDRA) with the SymbotexTM mesh

Conditions
littekenbreuk
Incisional hernia
ventral hernia
10041297
Registration Number
NL-OMON56620
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
49
Inclusion Criteria

- 18 years or older
- Elective HYDRA-surgery
- Midline incisional hernia larger than 4 centimetres in mean width
- Sufficient knowledge of the Dutch language to be able to understand and fill
in the questionnaires
- Signed informed consent form by patient

Exclusion Criteria

- Pregnant at inclusion - Inclusion in other trials with interference of the
primary and secondary endpoints - ASA >3 - Hernia defect larger than 10
centimetres in mean width - Incarcerated hernias or emergency procedure -
Unable to perform a trunk flexion - Incapacitated patients

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary objective of this study is to assess anatomical restoration and<br /><br>function of the linea alba one year after surgery by ultrasonography and<br /><br>measuring the mean peak torque during trunk flexion using a BioDexTM machine.</p><br>
Secondary Outcome Measures
NameTimeMethod
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