CompletedNot Applicable

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

Turkey (Türkiye)82 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative length of hospital stay

Timeframe: From the end of surgery until hospital discharge, up to 10 days

Trial details

NCT IDNCT05962320

SponsorKaradeniz Technical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

View on ClinicalTrials.gov More ERAS trials