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Идёт набор NCT07549113

Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias

Без фазы С лечением Incisional Hernia Repair Ventral Hernia Repair

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: Botulinum Toxin A (Botox ), Progressive Preoperative Pneumoperitoneum, Combined Preoperative Preparation, Standard Preoperative Management.
Кому может быть актуально
Состояния в реестре: Incisional Hernia Repair, Ventral Hernia Repair. 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
Россия
Следующий шаг
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Официальное название

Comparative Evaluation of Different Preoperative Optimization Strategies in Patients With Large, Complex, and Giant Incisional Hernias

Обзор

Patients with large, complex, or giant incisional hernias often require advanced preoperative optimization to facilitate safe abdominal wall reconstruction and reduce postoperative complications. Several strategies are currently used in clinical practice, including botulinum toxin A injection, progressive preoperative pneumoperitoneum, and their combination. However, the optimal differentiated approach based on hernia characteristics and abdominal wall tissue deficiency remains unclear. This study aims to compare the effectiveness and safety of different preoperative preparation strategies in patients with large postoperative ventral hernias and loss of abdominal wall domain. Outcomes of patients receiving botulinum toxin A, progressive preoperative pneumoperitoneum, combined preparation, or no specific preparation will be analyzed. The study will evaluate operative feasibility, ability to achieve fascial closure, postoperative complications, recurrence, and overall treatment outcomes.

Подробное описание

Large and giant incisional hernias remain a major challenge in abdominal wall surgery. In patients with loss of domain, reduced abdominal cavity volume, lateral muscle retraction, and soft tissue deficiency, standard hernia repair may be associated with high tension closure, respiratory compromise, abdominal compartment syndrome, wound complications, and recurrence.

Preoperative optimization techniques such as chemical component relaxation with botulinum toxin A and progressive preoperative pneumoperitoneum have been increasingly used to improve abdominal wall compliance and restore abdominal domain. Combined use of these methods may provide additional benefit in selected patients.

The present prospective comparative study is designed to assess a differentiated treatment strategy in which the method of preoperative preparation is selected according to clinical and anatomical characteristics of the hernia defect.

Participants will be allocated to one of the following groups:

Botulinum toxin A Progressive preoperative pneumoperitoneum Combined botulinum toxin A plus pneumoperitoneum No specific preoperative preparation

Primary and secondary outcomes may include technical feasibility of repair, need for component separation, successful fascial closure, perioperative morbidity, hospital stay, recurrence rate, and patient recovery.

The results of this study may help optimize patient selection and develop evidence-based algorithms for management of complex abdominal wall defects.

Вмешательства

  • Препарат Botulinum Toxin A (Botox )
    Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature.
  • Процедура Progressive Preoperative Pneumoperitoneum
    Gradual insufflation of the peritoneal cavity before surgery.
  • Процедура Combined Preoperative Preparation
    Combination of botulinum toxin A and progressive pneumoperitoneum.
  • Другое Standard Preoperative Management
    Routine preparation without specific optimization techniques.

Первичные конечные точки

  • Successful Midline Fascial Closure Rate [Срок оценки: Intraoperative assessment]
Вторичные конечные точки (4)
  • Postoperative Complication Rate [Срок оценки: 30 days after surgery]
  • Length of Hospital Stay [Срок оценки: From operation to discharge (up to 30 days)]
  • Hernia Recurrence Rate [Срок оценки: 12 months after surgery]
  • Need for Component Separation Technique [Срок оценки: Intraoperative assessment]

Критерии участия

Критерии включения

  • Adults aged 18 years or older
  • Patients with ventral incisional hernia requiring elective surgical repair
  • Large and/or complex hernia defects requiring preoperative preparation
  • Ability to provide informed consent

Критерии исключения

  • Age under 18 years
  • Emergency surgery
  • Pregnancy
  • Contraindications to botulinum toxin A injection or progressive pneumoperitoneum
  • Severe uncontrolled comorbidities precluding surgery
  • Inability or refusal to provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Россия · 1 центр
  • Ochapovsky Regional Clinical Hospital No.1 — Krasnodar

Идентификаторы

NCT: NCT07549113 · AWR-PPP-BTA-2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗