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

NCT05962320 | Completed

• 1 other identifier: KaradenizTU
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ERAS; Surgery; Appendicitis

Keywords

Appendectomy; Nurse; Child; Pain; Length of Stay; Anxiety; Fear; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

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

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

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.

Interventions

Education and counselling OTHER

Education and counselling of patients and their parents

mERAS Group

Avoiding the use of nasogastric catheters, drains and urinary catheters OTHER

Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible

mERAS Group

Stimulation of intestinal motility in the postoperative period OTHER

Stimulation of intestinal motility in the postoperative period

mERAS Group

Initiation of oral intake in the early postoperative period OTHER

Initiation of oral intake in the early postoperative period

mERAS Group

Early removal of the patient by reducing postoperative IV fluid infusion OTHER

Early removal of the patient by reducing postoperative IV fluid infusion

mERAS Group

Initiation of early mobilization of the patient in the postoperative period OTHER

Initiation of early mobilization of the patient in the postoperative period

mERAS Group

Reducing opioid use and ensuring pain management OTHER

Reducing opioid use and ensuring pain management

mERAS Group

Implement nausea and vomiting prophylaxis OTHER

Implement nausea and vomiting prophylaxis

mERAS Group

Management of thirsty OTHER

Management of thirsty

mERAS Group

Management of fear and stress OTHER

Use of recommended non-pharmacological interventions in the management of fear and stress

mERAS Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Appendicitis; Pain; Anxiety Disorders; Vomiting

Interventions

Educational Status; Counseling; Drainage; Urinary Catheters

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Therapeutics; Surgical Procedures, Operative; Catheters; Equipment and Supplies

Study Officials

• Buket MERAL, Msc

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research asistant - MSc

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 27, 2023
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 31, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

TU (1)