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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05962320
Enrollment
82
Registered
2023-07-27
Start date
2023-10-01
Completion date
2024-05-31
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, ERAS, Surgery

Keywords

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

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.

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.

Interventions

OTHEREducation and counselling

Education and counselling of patients and their parents

OTHERAvoiding 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

OTHERStimulation of intestinal motility in the postoperative period

Stimulation of intestinal motility in the postoperative period

OTHERInitiation of oral intake in the early postoperative period

Initiation of oral intake in the early postoperative period

OTHEREarly removal of the patient by reducing postoperative IV fluid infusion

Early removal of the patient by reducing postoperative IV fluid infusion

OTHERInitiation of early mobilization of the patient in the postoperative period

Initiation of early mobilization of the patient in the postoperative period

OTHERReducing opioid use and ensuring pain management

Reducing opioid use and ensuring pain management

OTHERImplement nausea and vomiting prophylaxis

Implement nausea and vomiting prophylaxis

OTHERManagement of thirsty

Management of thirsty

OTHERManagement of fear and stress

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

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative length of hospital stayFrom the end of surgery until hospital discharge, up to 10 daysThe postoperative length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.

Secondary

MeasureTime frameDescription
Readmissionup to 30 days after dischargeReadmission to the hospital will be recorded in hours.
Postoperative painAssessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hoursPostoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome
Postoperative fearAssessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hoursPostoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe fear, worse outcome.
Postoperative anxietyAssessed 2 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 12 hoursPostoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe anxiety, worse outcome.
Complicationsup to 30 days after dischargePostoperative minor and major complications will be recorded.
Postoperative thirstup to the first oral intake, an average 2 daysPostoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.
Time of first mobilizationup to the first mobilization, an average 12 hoursThe first time of postoperative mobilization will be recorded in hours. Higher scores indicate delayed mobilization. This means a worse outcome.
Time of first defecationup to the first defecation, an average 3 daysThe first time of postoperative defecation will be recorded in hours. Higher scores indicate delayed defecation. This means a worse outcome.
Postoperative nausea-vomitingAssessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hoursPostoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe nause, worse outcome

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026