Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Appendicitis; ERAS
• Intervention / Treatment: Other: Education and counselling; Other: Avoiding the use of nasogastric catheters, drains and urinary catheters; Other: Stimulation of intestinal motility in the postoperative period; Other: Initiation of oral intake in the early postoperative period; Other: Early removal of the patient by reducing postoperative IV fluid infusion; Other: Initiation of early mobilization of the patient in the postoperative period; Other: Reducing opioid use and ensuring pain management; Other: Implement nausea and vomiting prophylaxis; Other: Management of thirsty; Other: Management of fear and stress

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Trabzon
    • Trabzon, Trabzon, Turkey (Türkiye), 61080
      • Karadeniz Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standart Care Group; Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.
Experimental: mERAS Group; 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	Other: Education and counselling; Education and counselling of patients and their parents; Other: Avoiding the use of nasogastric catheters, drains and urinary catheters; Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible; Other: Stimulation of intestinal motility in the postoperative period; Stimulation of intestinal motility in the postoperative period; Other: Initiation of oral intake in the early postoperative period; Initiation of oral intake in the early postoperative period; Other: Early removal of the patient by reducing postoperative IV fluid infusion; Early removal of the patient by reducing postoperative IV fluid infusion; Other: Initiation of early mobilization of the patient in the postoperative period; Initiation of early mobilization of the patient in the postoperative period; Other: Reducing opioid use and ensuring pain management; Reducing opioid use and ensuring pain management; Other: Implement nausea and vomiting prophylaxis; Implement nausea and vomiting prophylaxis; Other: Management of thirsty; Management of thirsty; Other: Management of fear and stress; Use of recommended non-pharmacological interventions in the management of fear and stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of hospital stay	The postoperative length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.	From the end of surgery until hospital discharge, up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Postoperative minor and major complications will be recorded.	up to 30 days after discharge
Readmission	Readmission to the hospital will be recorded in hours.	up to 30 days after discharge
Postoperative thirst	Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.	up to the first oral intake, an average 2 days
Time of first mobilization	The first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.	up to the first mobilization, an average 12 hours
Time of first defecation	The first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.	up to the first defecation, an average 3 days
Postoperative pain	Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome	Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours
Postoperative fear	Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe fear, worse outcome.	Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
Postoperative anxiety	Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe anxiety, worse outcome.	Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
Postoperative nausea-vomiting	Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe nause, worse outcome	Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Buket MERAL, Msc, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Nurse; Child; Pain; Anxiety; Vomiting; Fear; Length of Stay; Appendectomy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Signs and Symptoms, Digestive; Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Vomiting; Appendicitis; Therapeutics; Surgical Procedures, Operative; Equipment and Supplies; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Socioeconomic Factors; Population Characteristics; Behavioral Disciplines and Activities; Mental Health Services; Catheters; Educational Status; Drainage; Counseling; Urinary Catheters
• Other Study ID Numbers: KaradenizTU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The individual participant data, with identifying information concealed, forming the basis of the results reported in this article, will be made available upon reasonable request to the corresponding author 6-12 months after publication of the article. Researchers should contact the corresponding author to request access to the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No