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NCT Number: NCT05962320

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

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.

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Key information

Conditions

ERAS Anxiety Disorders Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Surgery Vomiting

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education and counselling

Other

Education and counselling of patients and their parents

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

Stimulation of intestinal motility in the postoperative period

Other

Stimulation of intestinal motility in the postoperative period

Initiation of oral intake in the early postoperative period

Other

Initiation of oral intake in the early postoperative period

Early removal of the patient by reducing postoperative IV fluid infusion

Other

Early removal of the patient by reducing postoperative IV fluid infusion

Initiation of early mobilization of the patient in the postoperative period

Other

Initiation of early mobilization of the patient in the postoperative period

Reducing opioid use and ensuring pain management

Other

Reducing opioid use and ensuring pain management

Implement nausea and vomiting prophylaxis

Other

Implement nausea and vomiting prophylaxis

Management of thirsty

Other

Management of thirsty

Management of fear and stress

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complications

    Time frame: up to 30 days after discharge

    Postoperative minor and major complications will be recorded.

  2. Readmission

    Time frame: up to 30 days after discharge

    Readmission to the hospital will be recorded in hours.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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