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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962320
• Other study ID #: KaradenizTU
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: Karadeniz Technical University
• Contact: Buket MERAL, Msc
• Phone: +90 4622300476
• Email: buketguvenir[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• ERAS
• Surgery

Intervention

Other:
• Education and counselling
Education and counselling of patients and their parents
• Avoiding 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
• Stimulation of intestinal motility in the postoperative period
Stimulation of intestinal motility in the postoperative period
• Initiation of oral intake in the early postoperative period
Initiation of oral intake in the early postoperative period
• Early removal of the patient by reducing postoperative IV fluid infusion
Early removal of the patient by reducing postoperative IV fluid infusion
• Initiation of early mobilization of the patient in the postoperative period
Initiation of early mobilization of the patient in the postoperative period
• Reducing opioid use and ensuring pain management
Reducing opioid use and ensuring pain management
• Implement nausea and vomiting prophylaxis
Implement nausea and vomiting prophylaxis
• Management of thirsty
Management of thirsty
• Management of fear and stress
Use of recommended non-pharmacological interventions in the management of fear and stress

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications	Postoperative minor and major complications will be recorded.	up to 30 days after discharge
Secondary	Readmission	Readmission to the hospital will be recorded in hours.	up to 30 days after discharge
Secondary	Postoperative pain	Postoperative pain will be evaluated with Numeric Pain Scale. Higher scores mean more severe pain, worse outcome	up to 2 weeks
Secondary	Postoperative fear	Postoperative fear will be evaluated with Children's Fear Scale. Higher scores mean more severe pain, worse outcome.	up to 2 weeks
Secondary	Postoperative anxiety	Postoperative anxiety will be evaluated with Children's State Anxiety. Higher scores mean more severe pain, worse outcome.	up to 2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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