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

Karadeniz Technical University82 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Interventions

Education and counsellingOTHER

Education and counselling of patients and their parents

Avoiding the use of nasogastric catheters, drains and urinary cathetersOTHER

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 periodOTHER

Stimulation of intestinal motility in the postoperative period

Initiation of oral intake in the early postoperative periodOTHER

Initiation of oral intake in the early postoperative period

Early removal of the patient by reducing postoperative IV fluid infusionOTHER

Early removal of the patient by reducing postoperative IV fluid infusion

Initiation of early mobilization of the patient in the postoperative periodOTHER

Initiation of early mobilization of the patient in the postoperative period

Reducing opioid use and ensuring pain managementOTHER

Reducing opioid use and ensuring pain management

Implement nausea and vomiting prophylaxisOTHER

Implement nausea and vomiting prophylaxis

Management of thirstyOTHER

Management of thirsty

Management of fear and stressOTHER

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From the end of surgery until hospital discharge, up to 10 days

Secondary Outcomes

Complications

Postoperative minor and major complications will be recorded.

Time frame: up to 30 days after discharge

Readmission

Readmission to the hospital will be recorded in hours.

Time frame: up to 30 days after discharge

Postoperative pain

Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Assessed 5 times on the day of surgery (Postoperative Day 0) after patient awakening, approximately every 4-6 hours

Postoperative thirst

Postoperative thirst will be evaluated with Numeric Thirst Scale. Higher scores mean more severe pain, worse outcome.

Time frame: 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.

Time frame: 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.

Time frame: up to the first defecation, an average 3 days