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Набор скоро начнётся NCT07599501

Nutritional Supplementation to Improve Colorectal Cancer Surgery

Без фазы С лечением Colorectal Cancer Colorectal Surgery

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: Diet Optimization (DO), Oral Nutritional Supplement (ONS).
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Colorectal Surgery. 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
Италия
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

Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial

Обзор

This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.

Подробное описание

The rate of postoperative complications after colorectal cancer surgery is around 35%. The preoperative nutritional status significantly influences the postoperative outcomes, and several studies have investigated the effect of perioperative nutritional interventions with mixed results. This study aims to explore the effect of perioperative Oral Nutritional Supplementation (ONS) on the postoperative outcomes of colorectal cancer patients receiving preoperative dietary optimization. Participants scheduled for elective curative colorectal cancer surgery will undergo a detailed preoperative nutritional screening and will be randomized to receive either an optimized diet alone or an optimized diet and perioperative ONS. Postoperative complications will be collected and registered until 60 days after surgery. The participants' nutritional status will be evaluated 60 days and 180 days after surgery.

Вмешательства

  • Другое Diet Optimization (DO)
    Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments.
  • Пищевая добавка Oral Nutritional Supplement (ONS)
    ONS will consist of LH Blu® (Lionhealth Italia Srl). LH Blu® is categorized as a food for special medical purposes and is indicated for the treatment of malnourished patients. ONS will start 14 days before the planned intervention with a tailored dosage decided according to the malnutrition risk (low vs medium).

Первичные конечные точки

  • Postoperative complications [Срок оценки: 30 days from surgery]
Вторичные конечные точки (9)
  • Postoperative septic complications [Срок оценки: 30 days from surgery]
  • Comprehensive Complication Index (CCI) [Срок оценки: 30 days from surgery]
  • Length of hospital stay [Срок оценки: 30 days from surgery]
  • Hospital readmission [Срок оценки: 30 days from surgery]
  • Sarcopenia [Срок оценки: Six months after surgery]
  • Normal weight [Срок оценки: 60 days after surgery]
  • Mini Nutritional Assessment (MNA) score [Срок оценки: 60 days after surgery]
  • EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score [Срок оценки: 60 days after surgery]
  • Proctitis [Срок оценки: Six months after surgery]

Критерии участия

Критерии включения

  • Participants aged more than 18 years old.
  • Histological diagnosis of colorectal adenocarcinoma.
  • Participants scheduled for elective minimally invasive colorectal resection.
  • Participants with a preoperative MUST score equal to or below 2. Exclusion criteria
  • Any condition that, in the opinion of the investigator, may interfere with the study procedures.
  • Emergent surgery.
  • Planned open surgery. Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.
  • Any concomitant surgery unrelated to the primitive colorectal cancer (for example, concomitant liver metastasis resection).
  • Participants with preoperative MUST score > 2.
  • Pregnant or breastfeeding participants. Women of childbearing potential must agree to use a reliable contraceptive method. Otherwise, a pregnancy urine test must be performed at each study visit to exclude a potential pregnancy.

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Италия · 1 центр
  • IRCCS Humanitas Research Hospital — Rozzano

Идентификаторы

NCT: NCT07599501 · CHR1-11-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗