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Идёт набор NCT07159659

Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection

Без фазы С лечением Thoracic Neoplasms

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: MCT Diet.
Кому может быть актуально
Состояния в реестре: Thoracic Neoplasms. Базовые параметры: 18 лет — 80 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Lung resection, a critical treatment for various thoracic diseases, including lung cancer, often necessitates prolonged hospitalization due to rare but severe postoperative complications such as chyle leaks, with an occurrence of 0.25%-3%, prolonging chest drainage, and delaying recovery. Therefore, effective postoperative care is essential for optimizing outcomes, reducing complications, and expediting recovery. Recent studies have highlighted the significant potential of medium-chain triglyceride (MCT) diets, owing to their unique absorption pathway and metabolic properties. MCT contains mainly medium-chain fatty acids (MCFA), which is absorbed in the intestine and transported to the liver via the portal system instead of the lymphatic system. This helps to bypass the lymphatic system, thereby reducing the volume of lymph. MCFAs also provide better energy utilization in stressed condition since it does not require carnitine shuttle upon metabolism, which is beneficial to post-operation recovery. Several studies have demonstrated the benefits of MCT diets in managing chyle leaks and supporting gastrointestinal recovery, particularly in conditions that strain the lymphatic system. For instance, short-term MCT-enriched diets have been associated with improved post-operation recovery of gastrointestinal, hepatic and renal functions, reduced total chest drainage volumes, and shorter hospital stay when compared to regular diet groups. Patients with post-operative chyle leak following thoracic surgery are often given an MCT diet to reduce chest drain volume and hence shorten hospital stay. Based on the successful use of MCT diet on patients with chyle leak after lobectomy, it is hypothesized that patients with chylothorax provided with post-operative MCT diet can also shorten hospital stay by decreasing chest drainage. Therefore, a prospective and randomized trial is designed to investigate how post-operative MCT diet in lung resection patients without chylothorax may affect hospital stay and post-operative recovery.

Подробное описание

This study is a single-center, prospective, randomized trial designed to investigate how a post-operative diet enriched with MCT affects recovery in patients undergoing video-assisted thoracic surgery (VATS). Medical students from the Chinese University of Hong Kong, under the supervision of the principal investigator, will conduct the study, including obtaining consent and collecting data. Experienced surgeons at the Prince of Wales Hospital will perform the VATS procedures.

2.2 Hypotheses

1. MCT diet can speed up post-operative recovery and shorten hospital length of stay. 2. MCT diet poses no adverse effects in post-operative recovery for patients without chyle leak following lung surgery. 3. The use of MCT diet after discharge for 2 weeks can enhance patient recovery and possibly reduce readmissions or complications.

Вмешательства

  • Пищевая добавка MCT Diet
    MCT diet for patients following lung resection

Первичные конечные точки

  • hospital length of stay (LOS) [Срок оценки: From the end of the lung resection procedure until the time of patient discharge, assessed up to 7 days post-surgery]
Вторичные конечные точки (5)
  • Total Chest Drain Output (mL) [Срок оценки: From the end of the lung resection procedure until the time of chest drain removal assessed up to 7 days post-surgery]
  • Patient Satisfaction and Tolerability [Срок оценки: Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge]
  • Number of Participants with Symptoms Associated with MCT Diet [Срок оценки: Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge]
  • Number of patients with Infection symptoms [Срок оценки: Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge]
  • Number of patients with infection risk [Срок оценки: Upon discharge (assessed up to 7 days post-surgery), 2 weeks post discharge, 3 months post discharge]

Критерии участия

Критерии включения

General Inclusion Criteria for All procedures:

  • Age between 18 - 80 years
  • Body mass index <35 kg/m2
  • Suitable for minimally invasive surgery
  • Willingness to participate as demonstrated by giving informed consent

Project-specific Criteria:

1\. Patients performed lobectomy with lymph node dissection

Критерии исключения

Patient general exclusion criteria:

  • Contraindication to general anesthesia
  • Severe concomitant illness that drastically shortens life expectancy or increases the risk of therapeutic intervention
  • Untreated active infection
  • Non-correctable coagulopathy
  • Emergency surgery
  • Vulnerable population (e.g. mentally disabled, pregnancy)

Project-specific Criteria

  • Segmentectomy
  • Pleurodesis
  • Esophageal procedures
  • Redo/readmitted patients for lung resection
  • Chylothorax (Triglyceride > 110 mL, excluded at day 1 routine lab check)
  • Air leak (> 30 mL/min when back to ward)
  • Heart Failure
  • Renal failure (estimated GFR < 30; CKD grading stage 4-5)
  • Moderate to severe adhesion (defined at randomization by surgeon; criteria include estimated surface area of adhesion and staging)
  • History of tuberculosis or empyema

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Гонконг · 1 центр
  • Prince of Wales Hospital — Shatin

Идентификаторы

NCT: NCT07159659 · MCT Study Protocol version 1.1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗