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临床试验/NCT06981572
NCT06981572已完成不适用

Comparison of the Effectiveness of Implementing Modified ERAS Protocols vs. Standard Management in Pediatric Patients Undergoing Major Gastrointestinal Surgery

Indonesia University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Length of stay

研究概览

简要总结

Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which can cause pain, stress, and slowing down the recovery time for normal bowel function, thus further prolonging the patient's stay in hospital. Enhanced recovery after surgery (ERAS) is a concept that seeks faster recovery times for pediatric patients and shortens the length of hospital stay while still improving postoperative outcomes. The ERAS modification protocol aims to optimize inpatient care and minimize patient discomfort. Studies show that implementing the modified ERAS protocol can reduce the duration of hospitalization and the incidence of postoperative complications as well as speedy recovery. However, currently the standard ERAS protocol is difficult to apply to pediatric patients. This study will determine the comparison of the effectiveness of the ERAS modification protocol with the standard protocol in reducing length of stay and improving postoperative outcomes for pediatric patients at RSCM who underwent major gastrointestinal surgery using the ERAS modification method.

详细描述

Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which can cause pain, stress, and slowing down the recovery time for normal bowel function, thus further prolonging the patient's stay in hospital. Enhanced recovery after surgery (ERAS) is a concept that seeks faster recovery times for pediatric patients and shortens the length of hospital stay while still improving postoperative outcomes. ERAS was first introduced by a Danish surgeon, Henrik Kehlet in the 1990s to reduce perioperative stress and organ dysfunction in surgical patients. ERAS is an evidence-based technique and combines and optimizes various multidisciplinary methods used in conventional surgical management, includes surgery, anesthesia, nursing, and nutrition. ERAS emphasizes perioperative preparation including preoperative counseling, limited time in preoperative fasting, optimal anesthesia, minimally invasive techniques, immediate postoperative oral nutrition and mobilization, and non-routine use of drainage and surgical tubes. The ERAS modification protocol aims to optimize inpatient care and minimize patient discomfort. Studies show that implementing the modified ERAS protocol can reduce the duration of hospitalization and the incidence of postoperative complications as well as speedy recovery. However, currently the standard ERAS protocol is difficult to apply to pediatric patients because several conditions are not possible in pediatric patients, for example, administering anticoagulants, post-operative fasting, etc., thus requiring modifications that are tailored to the characteristics of the patients at Ciptomangunkusumo Hospital. Children experience a more complex surgical stress response than adult patients. Conventional perioperative management in children often results in greater physical stress. Therefore, perioperative management in children needs to be optimized.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
1 Month 至 2 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 1 month to 2 years
  • •The patient underwent major gastrointestinal surgery
  • •ASA 1 and 2 physical status
  • •The patient will undergo elective lower abdominal surgery with general and regional anesthesia

排除标准

  • •Patients with cyanotic congenital heart defects
  • •Patients with metabolic disorders
  • •Patients with decreased consciousness
  • •Patients with severe cognitive impairment
  • •Patients with relaparotomy due to surgical complications

研究组 & 干预措施

modified ERAS protocol applied

Active Comparator

patients modified ERAS protocol applied

干预措施: Modified Enhanced Recovery After Surgery Protocol (Procedure)

standart protocol applied

No Intervention

patients with standart protocol applied

结局指标

主要结局

Length of stay

时间窗: The timeframe is calculated from when the patient undergoes preoperative assessment until discharge from the hospital, up to 3 months.

Patients' length of stay in the hospital, measured in days

次要结局

  • Blood glucose level (mg/dL)(The time frame includes 1 day before surgery (preoperative), during surgery (intraoperative), and on the 3rd and 5th days after surgery (postoperative))
  • Blood electrolyte levels (Na, K, Cl)(Blood electrolyte levels assessed 1 day before surgery (preoperative) and on the 3rd day after surgery (postoperative))
  • Oral Nutrition Initiation Time(The time frame is calculated from the end of the surgery and will be evaluated up to the time of the patient's discharge from the hospital)
  • Time to mobilization(The time frame is calculated from the end of surgery and will be evaluated up to the time of the patient's discharge from the hospital)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andi Ade Wijaya Ramlan

Head of Department of Anesthesiology and Intensive Therapy

Indonesia University

研究点 (1)

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