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Набор скоро начнётся NCT07422441

Compliance-Guided Abdominal Wall Closure Strategy in Large Ventral Hernia Repair

Без фазы С лечением Hernia, Ventral Hernia Incisional Postoperative Complications Respiratory Insufficiency

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: Compliance-Guided Abdominal Wall Closure Decision Strategy.
Кому может быть актуально
Состояния в реестре: Hernia, Ventral, Hernia Incisional, Postoperative Complications, Respiratory Insufficiency. 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
Список центров уточняется — проверьте первичный протокол.
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

Impact of a Compliance-Guided Intraoperative Abdominal Wall Closure Decision Strategy on Early Postoperative Respiratory Failure After Large Ventral Hernia Repair Following Preoperative Botulinum Toxin A

Обзор

People undergoing repair of large ventral hernias can develop breathing problems after surgery, especially around the time when the abdominal wall is closed. During closure, pressure inside the abdomen may increase and lung mechanics can worsen. This study will evaluate a structured intraoperative decision approach that uses standard anesthesia measurements of static respiratory system compliance at predefined timepoints to support the choice of abdominal wall closure technique. The main goal is to assess the rate of early postoperative respiratory failure within 72 hours after surgery.

Подробное описание

This is a prospective, single-arm, decision-guided interventional study in adults undergoing elective repair of large ventral hernias after preoperative botulinum toxin A preparation as part of the local prehabilitation pathway. The study focuses on the intraoperative abdominal wall closure phase, when physiological changes may increase the risk of early postoperative respiratory complications.

Mechanical ventilation is standardized during measurement timepoints using volume-controlled ventilation with tidal volume set to 6 mL per kg of ideal body weight and a positive end-expiratory pressure of 10 cmH2O. Full neuromuscular blockade is ensured to minimize measurement variability. Static respiratory system compliance is recorded at three predefined timepoints: after endotracheal intubation before skin incision (baseline), during abdominal wall closure (decision timepoint), and before extubation. The intraoperative decision strategy considers a closure physiologically tolerable when static compliance remains at least 70 percent of the baseline value. If compliance falls below this threshold at the closure decision timepoint, the surgical team considers avoiding tension closure and may use a bridging or alternative closure approach according to clinical judgment. When intra-abdominal pressure is measured as part of routine care, these values are recorded as an additional physiological parameter.

Perioperative data are captured in a dedicated case report form, and patients are observed for early respiratory outcomes during the first 72 hours after surgery.

Вмешательства

  • Другое Compliance-Guided Abdominal Wall Closure Decision Strategy
    A predefined intraoperative decision strategy that uses standardized measurements of static respiratory system compliance (Cstat) during abdominal wall closure to support selection of closure technique, with a predefined physiological tolerance threshold based on the baseline measurement.

Первичные конечные точки

  • Incidence of postoperative respiratory failure within 72 hours [Срок оценки: Within 72 hours after surgery]
Вторичные конечные точки (3)
  • Change in static respiratory system compliance from baseline to closure decision [Срок оценки: Intraoperative (baseline to closure decision timepoint)]
  • Proportion of cases requiring change in abdominal wall closure strategy [Срок оценки: Intraoperative (during abdominal wall closure)]
  • Intra-abdominal pressure during abdominal wall closure [Срок оценки: Intraoperative (at time of measurement)]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Elective repair of a large ventral abdominal wall hernia (including incisional hernia)
  • Preoperative botulinum toxin A preparation performed as part of the local prehabilitation pathway
  • Preoperative abdominal CT available
  • General anesthesia with mechanical ventilation and feasibility of standardized intraoperative respiratory mechanics measurements

Критерии исключения

  • Severe preoperative respiratory failure judged to preclude standardized intraoperative respiratory mechanics assessment
  • Inability to obtain reliable static respiratory system compliance measurements at predefined timepoints
  • Hemodynamic instability preventing protocolized measurements (as judged by the anesthesiologist)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07422441 · CLOSE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗