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

NCT ID: NCT05962320

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-05-31

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.

Conditions

ERAS; Surgery; Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

mERAS Group

• 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
• Providing pain management with opioid-limiting pharmacologic and non-pharmacological interventions
• Non-pharmacological interventions in management nausea and vomiting
• Management of thirsty through non-pharmacological interventions
• Management of fear and anxiety through non-pharmacological interventions

Group Type: EXPERIMENTAL

Implement nausea and vomiting prophylaxis

Intervention Type: OTHER

Implement nausea and vomiting prophylaxis

Management of thirsty

Intervention Type: OTHER

Management of thirsty

Education and counselling

Intervention Type: OTHER

Education and counselling of patients and their parents

Avoiding the use of nasogastric catheters, drains and urinary catheters

Intervention Type: OTHER

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

Intervention Type: OTHER

Stimulation of intestinal motility in the postoperative period

Initiation of oral intake in the early postoperative period

Intervention Type: OTHER

Initiation of oral intake in the early postoperative period

Early removal of the patient by reducing postoperative IV fluid infusion

Intervention Type: OTHER

Early removal of the patient by reducing postoperative IV fluid infusion

Initiation of early mobilization of the patient in the postoperative period

Intervention Type: OTHER

Initiation of early mobilization of the patient in the postoperative period

Reducing opioid use and ensuring pain management

Intervention Type: OTHER

Reducing opioid use and ensuring pain management

Management of fear and stress

Intervention Type: OTHER

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

Standart Care Group

Patients in this group will receive standard care according to the practices of the clinic where the study will be conducted.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implement nausea and vomiting prophylaxis

Implement nausea and vomiting prophylaxis

Intervention Type: OTHER

Management of thirsty

Management of thirsty

Intervention Type: OTHER

Education and counselling

Education and counselling of patients and their parents

Intervention Type: OTHER

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

Intervention Type: OTHER

Stimulation of intestinal motility in the postoperative period

Stimulation of intestinal motility in the postoperative period

Intervention Type: OTHER

Initiation of oral intake in the early postoperative period

Initiation of oral intake in the early postoperative period

Intervention Type: OTHER

Early removal of the patient by reducing postoperative IV fluid infusion

Early removal of the patient by reducing postoperative IV fluid infusion

Intervention Type: OTHER

Initiation of early mobilization of the patient in the postoperative period

Initiation of early mobilization of the patient in the postoperative period

Intervention Type: OTHER

Reducing opioid use and ensuring pain management

Reducing opioid use and ensuring pain management

Intervention Type: OTHER

Management of fear and stress

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Buket MERAL

Research asistant - MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Buket MERAL, Msc

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Locations

Karadeniz Technical University

Trabzon, Trabzon, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KaradenizTU

Identifier Type: -

Identifier Source: org_study_id