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

September 30, 2025 updated by: Buket MERAL, Karadeniz Technical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative length of hospital stay
Time Frame: 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.
From the end of surgery until hospital discharge, up to 10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: up to 30 days after discharge
Postoperative minor and major complications will be recorded.
up to 30 days after discharge
Readmission
Time Frame: up to 30 days after discharge
Readmission to the hospital will be recorded in hours.
up to 30 days after discharge
Postoperative thirst
Time Frame: up to the first oral intake, an average 2 days
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
Time Frame: up to the first mobilization, an average 12 hours
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
Time Frame: up to the first defecation, an average 3 days
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
Time Frame: Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours
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
Time Frame: Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
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
Time Frame: Assessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hours
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
Time Frame: Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Buket MERAL, Msc, Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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