临床试验/NCT05962320

NCT05962320已完成不适用

Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial

Karadeniz Technical University1 个研究点分布在 1 个国家目标入组 82 人开始时间: 2023年10月1日最近更新: 2025年10月3日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Karadeniz Technical University
入组人数: 82
试验地点: 1
主要终点: Postoperative length of hospital stay

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Acute appendicitis is the most common abdominal emergency with more than 15 million cases reported worldwide. Although appendectomy is considered a safe surgical procedure, the incidence of complications is up to 10%. The Enhanced Recovery After Surgery (ERAS) has developed guidelines to improve postoperative patient outcomes. The protocol, which consists of more than 20 interventions in the preoperative, intraoperative and postoperative periods, shows that early discharge can be possible with multidisciplinary care given to surgical patients without risking patient safety.

详细描述

Appendicitis is a common clinical condition and often requires emergency treatment. Although appendectomy is a safe surgical procedure, there is a risk of complications. Pain is common, especially in the postoperative period, and the lack of care management leads to delayed mobilization and oral intake, delayed recovery and prolonged length of hospital stay. However, pain, nausea-vomiting, thirst, fear and stress could be managed with perioperative care. In addition, it is reported that the care provided based on the ERAS protocol shortens the length of hospital stay. In this respect, the aim of this study was to investigate the effect of ERAS protocol-based care on the length of hospital stay of children who were planned to undergo appendectomy. Postoperative pain level, stress and fear level, time to first mobilization, flatulence, defecation and oral intake, nausea, thirst were the secondary outcomes of this study.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None (Outcomes Assessor)

入排标准

年龄范围: 6 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥6 years and ≤17 years, girls or boys
•Underwent appendectomy
•Written informed consent or requirements of local/national ethical committee

排除标准

•ASA (American Society of Anesthesiologists, ASA) score of ≥ 3
•Any comorbidity/contraindication that may prevent mobilization and oral feeding
•The withdrawal criteria:
•During the surgery, the surgeon classified appendicitis as grade 0 (no appendicitis) or grade IIIB and above,
•during the postoperative period need for intensive care hospitalization patients in the control or the mERAS protocol group were staying in the same room,
•contraindications to the application of any intervention in the intervention group and/or the primary physician not approving the application of the intervention,
•the compliance rate of the interventions determined in the modified ERAS protocol being below 80%,
•the development of any other comorbidity (urinary calculi, intussusception, etc.),
•the change in the type of surgery during the operation, conversion from laparoscopic to open appendectomy.

研究组 & 干预措施

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Management of thirsty (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Education and counselling (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Avoiding the use of nasogastric catheters, drains and urinary catheters (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Stimulation of intestinal motility in the postoperative period (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Initiation of oral intake in the early postoperative period (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Early removal of the patient by reducing postoperative IV fluid infusion (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Initiation of early mobilization of the patient in the postoperative period (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Reducing opioid use and ensuring pain management (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Implement nausea and vomiting prophylaxis (Other)

mERAS Group

Experimental

Education and counselling of patients and their parents
Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible
Stimulation of intestinal motility in the postoperative period
Initiation of oral intake in the early postoperative period
Early removal of the patient by reducing postoperative IV fluid infusion
Initiation of early mobilization of the patient in the postoperative period
Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
Non-pharmacological interventions in management nausea and vomiting
Management of thirsty through non-pharmacological interventions
Management of fear and anxiety through non-pharmacological interventions

干预措施: Management of fear and stress (Other)

Standart Care Group

No Intervention

Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.

结局指标

主要结局

Postoperative length of hospital stay

时间窗: From the end of surgery until hospital discharge, up to 10 days

The postoperative length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.

次要结局

Complications(up to 30 days after discharge)
Readmission(up to 30 days after discharge)
Postoperative thirst(up to the first oral intake, an average 2 days)
Time of first mobilization(up to the first mobilization, an average 12 hours)
Time of first defecation(up to the first defecation, an average 3 days)
Complications(up to 30 days after discharge)
Readmission(up to 30 days after discharge)
Postoperative pain(Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours)
Postoperative fear(Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours)
Postoperative anxiety(Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours)
Postoperative nausea-vomiting(Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours)
Postoperative thirst(up to the first oral intake, an average 2 days)
Time of first mobilization(up to the first mobilization, an average 12 hours)
Time of first defecation(up to the first defecation, an average 3 days)

研究者

发起方

Karadeniz Technical University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Buket MERAL

Research asistant - MSc

Karadeniz Technical University

研究点 (1)

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