Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)
NCT ID: NCT06286124
Last Updated: 2024-02-29
Study Results
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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NOT_YET_RECRUITING
52 participants
OBSERVATIONAL
2024-04-30
2028-04-30
Brief Summary
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Detailed Description
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Objective: The main objective is to asses functional anatomical restoration of the linea alba through functioning in mean peak torque, and ultrasound examination.
Study design: Multicentre prospective cohort study. Study population: Adult patients with a midline incisional hernia ≥4 cm and ≤10 cm.
Intervention: Not applicable. Main study parameters/endpoints: The primary objective of this study is to assess anatomical restoration and function of the linea alba one year after surgery by ultrasonography and measuring the mean peak torque during trunk flexion using a BioDex(trademark) machine.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risk is associated with participation other than known complications for incisional hernia repair. HYDRA is part of standard care in the Alrijne Hospital, and the technique has previously been published. The mesh used in this study is being used on a world-wide scale. We do not expect additional risks with this study. As participants have to visit the Erasmus Medical Center (Erasmus MC) an additional three times and have to fill in additional questionnaires, there is a burden for enrolled patients.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Incisional Hernia patients
Patients with an Incisional Hernia, who present in the participating center
Hybrid Surgery
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)
Interventions
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Hybrid Surgery
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for 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
* Inclusion in other trials with interference of the primary and secondary endpoints
* American Society of Anesthesiologists Classification (ASA Classification) \> 3
* Hernia defect larger than 10 centimetres in mean width
* Incarcerated hernias or emergency procedure
* Unable to perform a trunk flexion
* Incapacitated patients
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Alrijne Hospital
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Prof. dr. Pieter J Tanis
Prof. dr.
Principal Investigators
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Pieter Tanis, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Alrijne Hospital
Leiden, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Willem Hueting, MSc
Role: primary
References
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van den Dop LM, de Smet GHJ, Bus MPA, Lange JF, Koch SMP, Hueting WE. A new three-step hybrid approach is a safe procedure for incisional hernia: early experiences with a single centre retrospective cohort. Hernia. 2021 Dec;25(6):1693-1701. doi: 10.1007/s10029-020-02300-9. Epub 2020 Sep 12.
Other Identifiers
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8612
Identifier Type: -
Identifier Source: org_study_id