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

Not Applicable

Recruiting

• Conditions: ERAS; Surgery; Appendicitis

• Registration Number: NCT05962320
• Lead Sponsor: Karadeniz Technical University

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.

Study Timeline

• Study First Submitted: 2023-06-18
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-27
• Study Start: 2023-08-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	up to 2 weeks	The length of hospital stay will be calculated in hours. Higher scores indicate delayed discharge. This means a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Readmission	up to 30 days after discharge	Readmission to the hospital will be recorded in hours.
Time of first mobilization	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.
Complications	up to 30 days after discharge	Postoperative minor and major complications will be recorded.
Postoperative pain	up to 2 weeks	Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome
Postoperative fear	up to 2 weeks	Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome.
Postoperative anxiety	up to 2 weeks	Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome.
Postoperative nausea-vomiting	up to 2 weeks	Postoperative nausea-vomiting will be evaluated with Baxter Retching Faces Scale. Higher scores mean more severe pain, worse outcome
Postoperative thirst	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.
Time of first defecation	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.

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey