Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Postoperative Complication, Recovery, Physiological. 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery: Single-center Prospective Study - FLATQUAL- Abdominal Surgery and Gas Transit
Обзор
The recovery of transit after surgery is an important parameter in postoperative evaluation. It generally reflects simple postoperative outcomes and allows the patient to return home. The quality of gas recovery after surgery has not been studied to our knowledge, but it is not uncommon for an operated patient to emit some gas considered as a recovery of transit when it is ultimately a false transit preceding a postoperative ileus. Furthermore, intestinal gases and their composition reflect the intestinal microbiota. This microbiota has been shown to be predictive of the appearance of an operative complication. As the analysis of this microbiota cannot be carried out routinely, it is important to be able to use a reflection of this microbiota in routine practice and to correlate it with the surgical outcomes. Intestinal gas therefore seems to be the tool of choice. The main objective is to evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality. The secondary objectives are to compare the quantity and quality of gases pre- and post-operatively and to define a predictive score for surgical complications, based on the number and quality of post-surgical gases. Data regarding gas transit are collected by the patient in a questionnaire the two days before the surgery and until the patient leaves hospital (or until day 15 post-operative if the patient is still hospitalized). Data regarding possible complications ((defined according to Dindo-Clavien as any deviation from the expected postoperative outcomes within 90 days following surgery) are collected throughout the hospital stay (day 0 : surgery to day 15 post-operatively), during the post-operative consultation (day 30) and during a telephone call to the patient (day 90). The expected results are to highlight a correlation between the quality/quantity of gases and post-operative outcomes. A predictive score for complications could then be proposed and validated during this study.
Первичные конечные точки
- To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality. [Срок оценки: From Day 0 (surgery) to the 90 post-operative days +/- 15 days.]
- To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality. [Срок оценки: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized.From Day 0 (surgery) to the 90 post-operative days +/- 15 days.]
- To evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality. [Срок оценки: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized.From Day 0 (surgery) to the 90 post-operative days +/- 15 days]
Вторичные конечные точки (4)
- to compare the quantity of gas pre- and post-operative [Срок оценки: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized]
- to compare the quantity of stools pre- and post-operative [Срок оценки: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized]
- to compare the quality of gases pre- and post-operative [Срок оценки: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized]
- to compare the quality of stool pre- and post-operative [Срок оценки: The 2 days before surgery and up to 15 days post-operative if the patient is still hospitalized]
Критерии участия
Критерии включения
- Patients ≥18 years old
- Indication for open or laparoscopic abdominal surgery
- Whose expected length of stay is ≥ 2 days
Non Inclusion Criteria:
- Patients requiring a stomy on the initial surgery
- Need for immediate postoperative intensive care
- Emergency surgery
- Patient not knowing how to read or write
- Poor understanding of the French language
- Person deprived of liberty by judicial or administrative decision
- Person subject to psychiatric care under duress
- Person subject to a legal protection measure
- Person unable to express consent
- Person objecting to participating in research
Критерии исключения
-Immediate post-operative intensive care
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Angers Hospital (visceral surgery department) — Angers
Идентификаторы
NCT: NCT06675097 · 49RC24_0335