Меню
Идёт набор NCT06108011

Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children

Без фазы С лечением Ileus Postoperative

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: Lollipop.
Кому может быть актуально
Состояния в реестре: Ileus Postoperative. Базовые параметры: до 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Lollipop on Postoperative Gastrointestinal Recovery in Children: A Randomised Controlled Trial

Обзор

Postoperative ileus is common in children. There are various method to prevent postoperative ileus. In this study, the investigators will explore the role of sucking lollipop after operation on the recovery of gastrointestinal function in children.

Подробное описание

Postoperative ileus is a common occurrence among children undergoing major operations, including gastrointestinal and spinal surgeries. It can result in physical discomfort, extended hospital stays, delayed resumption of activity and poor satisfaction with surgical care. The pathophysiology and course of postoperative ileus occurs in three phases: increased sympathetic activity, release of inflammatory mediators and vagal activation as ileus resolves. Multiple risk factors of postoperative ileus have been identified in various studies, including general risk factors such as significant blood loss, male gender and medical comorbidities like chronic obstructive pulmonary disease (COPD), as well as risk factors specific to the surgery, such as the laparotomy approach, emergency surgery and stoma formation.

Chewing gum, as a form of sham feeding, has been employed in adults and children as a modality to decrease risk of postoperative ileus. There has been concrete evidence that it could result in expedited recovery of gastrointestinal function after surgery in adult populations. However, it may not be a feasible option for infants and young children. Lollipop, on the other hand, is easier to apply in children which only require the action of sucking. It can stimulate the cephalic phase of digestion via vagal cholinergic stimulation and release of gastrointestinal hormone (gastrin and motilin) through its taste and absorption of sugar. The current evidence of lollipop in the recovery of postoperative gastrointestinal function in children is limited with only two randomised controlled trial published so far with satisfactory outcomes, yet both were not indexed and were not carried out in accordance with Consolidated Standards of Reporting Trials (CONSORT). Based on these reasons, the investigators plan to carry out a prospective, multiple-centred, non-blinded, randomized controlled trial using a parallel arm design on the effect of lollipop on recovery of gastrointestinal function after operation in children. Children recruited will be randomly assigned into either lollipop group or non-treatment group; lollipop will be given to children in treatment group after operation. Their outcomes will be compared.

Вмешательства

  • Другое Lollipop
    sucking of lollipop after operation

Первичные конечные точки

  • Time for participants to return of flatus [Срок оценки: 1 week]
  • Time for participants to first stool passage [Срок оценки: 1 week]
Вторичные конечные точки (3)
  • Time for participants to resumption of feeding [Срок оценки: 1 month]
  • Time for participants to discharge from hospital after operation [Срок оценки: 1 month]
  • Presence of any complications in participants [Срок оценки: 1 month]

Критерии участия

Критерии включения

  • Patients receiving major abdominal surgery (e.g.appendicectomy, choledochal cyst surgery, bowel resection etc)

Критерии исключения

  • Patients with neurological conditions that preclude sucking/swallowing.
  • Patients under sedation and/or mechanical ventilation and/or ionotropic support in the post operative period.
  • Patients with known food allergy or allergy to food coloring agents

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
Профилактика

Центры проведения

Гонконг · 1 центр
  • Department of Surgery, University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06108011 · LollipopTrial

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗