Clinical trial NCT05962320: Effect of Modified ERAS Protocol on Clinical Outcomes in Pediatric Patients With Appendectomy
Official title: Effect of Enhanced Recovery After Surgery Protocol Based Care on Patient Outcomes in Children With Appendicitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ERAS
Surgery
Appendicitis
Keywords: Appendectomy
Nurse
Child
Pain
Length of Stay
Anxiety
Fear
Vomiting
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital length of stay
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Complications
timeFrame: up to 30 days after discharge
measure: Readmission
timeFrame: up to 30 days after discharge
measure: Postoperative pain
timeFrame: up to 2 weeks
measure: Postoperative fear
timeFrame: up to 2 weeks
measure: Postoperative anxiety
timeFrame: up to 2 weeks
measure: Postoperative nausea-vomiting
timeFrame: up to 2 weeks
measure: Postoperative thirst
timeFrame: up to the first oral intake, an average 2 days
measure: Time of first mobilization
timeFrame: up to the first mobilization, an average 12 hours
measure: Time of first defecation
timeFrame: up to the first defecation, an average 3 days
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Buket MERAL, Msc
role: PRINCIPAL_INVESTIGATOR
References: