A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction
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: algorithm.
- Кому может быть актуально
- Состояния в реестре: Small Bowel Obstruction. 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
- Франция
- Следующий шаг
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Официальное название
Impact of a Procalcitonin-based Algorithm on Quality of Management in Patients With Uncomplicated Adhesion-related Small Bowel Obstruction Assessed by Textbook Outcome: a Multicenter Cluster-randomized Open-label Controlled Trial. (ALPROC)
Обзор
Adhesion-related small bowel obstruction is a common digestive emergency that can be managed either conservatively or surgically. However, the choice between these two approaches can be difficult due to the absence of specific signs. The objective of this study is to evaluate the clinical impact of a procalcitonin-based algorithm.
Подробное описание
Acute adhesion-related small bowel obstruction (ASBO) is a common digestive emergency accounting for 1% to 3% of all digestive emergencies. It is associated with a mortality rate of between 2% and 8%, although this figure may be as high as 25% when surgical treatment is delayed. In 2013, the World Society of Emergency Surgery's working group on ASBO suggested two distinct approaches for the management of acute ASBO. Conservative management includes the use of a nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 24 to 72 hours or surgical management. However, the efficacy of conservative management in this setting is a subject of debate, as it might delay the decision to perform surgery and increase the frequency of bowel resection (e.g. in the presence of bowel necrosis) or, in contrast, prompt an excessive number of unnecessary laparotomies. The efficacy of water-soluble contrast medium in this setting is also subject to debate, as data from a recent randomized clinical trial including 242 patients (ABOD study) combined with a meta-analysis in 2015 including 990 patients failed to demonstrate any value of gastrografin to reduce the surgery rate and length of stay. Three years ago, our team proposed the use of a marker of bacterial infection and bowel ischemia, procalcitonin (PCT), to help distinguish patients in whom conservative management is likely to be successful from those in whom surgical management was mandatory. Cutoffs of 0.2 µg/L (for failure of conservative management ) and 0.6 µg/L (for need for surgery) accurately identified more than 80% of patients. These cutoffs and data were confirmed in a second independent cohort, and were then used to propose an algorithm for the management of patients with ASBO. In this single-center, retrospective , case-control study, the investigators showed that introduction of this algorithm into patient management reduced i/ the time to surgery with no increase of the surgical management rate; ii/ the length of stay (with a 2-day difference). The investigators propose the hypothesis that introduction of the PCT-based algorithm improves the quality of management of patients with ASBO.
Вмешательства
- Диагностический тест algorithm
clinical examination and procalcitonin assessment
Первичные конечные точки
- proportion of patients achieving textbook outcome [Срок оценки: within 90 days after randomization.]
Вторичные конечные точки (6)
- 1-, 3-, 6-, 9-, 12-month recurrence rates [Срок оценки: within 12 postoperative months]
- QSH45 (questionnaire for satisfaction of hospitalized patients) score evaluating patient satisfaction at postoperative month 1 [Срок оценки: postoperative month 1]
- Clavien score postoperative month 1 [Срок оценки: postoperative month 1]
- CCI score [Срок оценки: postoperative month 1]
- Hospital length of stay [Срок оценки: postoperative month 12]
- Cumulative length of stay [Срок оценки: postoperative month 12]
Критерии участия
Критерии включения
- Uncomplicated acute adhesion-related small bowel obstruction (ASBO)
- Adults
- Patients able to express consent
- Signed written informed consent form
- Covered by national health insurance
Критерии исключения
- Disease-related criteria:
- Large bowel obstruction
- No previous abdominal surgery
- Signs of peritonitis or strangulation requiring emergency surgery)
- Obstruction within 4 weeks following previous surgery
- Ongoing or history of bowel cancer
- Ongoing or in history of inflammatory bowel disease
- History of abdominal radiotherapy
- Active infection
- Contraindication to contrast-enhanced CT scan
- Minors
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Pregnancy or breastfeeding
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
- Диагностика
Центры проведения
Франция · 1 центр
- Amiens Universitary Hospital — Amiens
Публикации
- Sabbagh C, Mauvais F, Tuech JJ, Tresallet C, Ortega-Debalon P, Mathonnet M, Lefevre JH, Lakkis Z, Fuks D, Muscari F, Dron B, Couderc P, Alves A, Regimbeau JM. Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial. BMC PMID 35236281
Идентификаторы
NCT: NCT03905239 · PI2018_843_0029