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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ERAS, Surgery, Appendicitis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥6 years and ≤18 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mERAS Group<br>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 Reducing opioid use and ensuring pain management Implement nausea and vomiting prophylaxis Management of thirsty Management of fear and stress | Other: Education and counselling<br>* Education and counselling of patients and their parents<br>Other: Avoiding the use of nasogastric catheters, drains and urinary catheters<br>* Avoiding the use of nasogastric catheters, drains and urinary catheters or/and removing them as early as possible<br>Other: Stimulation of intestinal motility in the postoperative period<br>* Stimulation of intestinal motility in the postoperative period<br>Other: Initiation of oral intake in the early postoperative period<br>* Initiation of oral intake in the early postoperative period<br>Other: Early removal of the patient by reducing postoperative IV fluid infusion<br>* Early removal of the patient by reducing postoperative IV fluid infusion<br>Other: Initiation of early mobilization of the patient in the postoperative period<br>* Initiation of early mobilization of the patient in the postoperative period<br>Other: Reducing opioid use and ensuring pain management<br>* Reducing opioid use and ensuring pain management<br>Other: Implement nausea and vomiting prophylaxis<br>* Implement nausea and vomiting prophylaxis<br>Other: Management of thirsty<br>* Management of thirsty<br>Other: Management of fear and stress<br>* Use of recommended non-pharmacological interventions in the management of fear and stress<br>|
| No Intervention: Standart Care Group<br>Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | The length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome. | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Postoperative minor and major complications will be recorded. | up to 30 days after discharge | 
| Readmission | Readmission to the hospital will be recorded in hours. | 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 | up to 2 weeks | 
| Postoperative fear | Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome. | up to 2 weeks | 
| Postoperative anxiety | Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome. | up to 2 weeks | 
| Postoperative nausea-vomiting | Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome | up to 2 weeks | 
| Postoperative thirst | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendectomy, Nurse, Child, Pain, Length of Stay, Anxiety, Fear, Vomiting