Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hybrid Surgery.
- Who it may be relevant to
- Registry conditions: Incisional Hernia of Midline of Abdomen. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Midline Restoration After HYbriD Incisional Hernia RepAir (HYDRA) With the SymbotexTM Mesh
Overview
The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine.
Detailed description
Rationale: Abdominal wall functioning has been reported to be higher in patients that underwent open incisional hernia repair compared to laparoscopic incisional hernia repair. With the use of a recently developed hybrid approach, we aim for a functional anatomical restoration of the linea alba while also achieving the technical advantages of the hybrid approach.
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.
Interventions
- Procedure Hybrid Surgery
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)
Primary outcome measures
- Mean peak torque 1 year [Time frame: 12 months]
Secondary outcome measures (8)
- Mean peak torque 2 years [Time frame: 24 months]
- Recurrent Incisional Hernia [Time frame: 1 month, 12 months and 24 months]
- Severity of surgical complications [Time frame: 1 month]
- Surgical complications [Time frame: 1 month]
- General Quality of Life [Time frame: pre-operative, 12 months and 24 months]
- Mesh specific Quality of Life [Time frame: 1 month, 12 months and 24 months]
- Scar satisfaction [Time frame: pre-operative, 1 day, 1 month]
- Pain in the abdominal region [Time frame: pre-operative, 1 day, 1 month]
Eligibility criteria
Inclusion criteria
- 18 years or older
- 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
- Pregnant at inclusion
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Alrijne Hospital — Leiden
Publications
- 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. PMID 32920734
Identifiers
NCT: NCT06286124 · 8612