Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Hybrid Surgery.
- Кому может быть актуально
- Состояния в реестре: Incisional Hernia of Midline of Abdomen. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Midline Restoration After HYbriD Incisional Hernia RepAir (HYDRA) With the SymbotexTM Mesh
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Hybrid Surgery
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)
Первичные конечные точки
- Mean peak torque 1 year [Срок оценки: 12 months]
Вторичные конечные точки (8)
- Mean peak torque 2 years [Срок оценки: 24 months]
- Recurrent Incisional Hernia [Срок оценки: 1 month, 12 months and 24 months]
- Severity of surgical complications [Срок оценки: 1 month]
- Surgical complications [Срок оценки: 1 month]
- General Quality of Life [Срок оценки: pre-operative, 12 months and 24 months]
- Mesh specific Quality of Life [Срок оценки: 1 month, 12 months and 24 months]
- Scar satisfaction [Срок оценки: pre-operative, 1 day, 1 month]
- Pain in the abdominal region [Срок оценки: pre-operative, 1 day, 1 month]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- Alrijne Hospital — Leiden
Публикации
- 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
Идентификаторы
NCT: NCT06286124 · 8612