跳至主要内容
临床试验/NCT06108011
NCT06108011招募中不适用

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

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Time for participants to return of flatus

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Time for participants to return of flatus

时间窗: 1 week

the time needed for flatus to happen after operation, in term as hours

Time for participants to first stool passage

时间窗: 1 week

The time needed for stool passage, in terms of hours

次要结局

  • Time for participants to resumption of feeding(1 month)
  • Time for participants to discharge from hospital after operation(1 month)
  • Presence of any complications in participants(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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