Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Официальное название

Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial

Обзор

To evaluate whether a postoperative therapeutic strategy, Fast Track, aimed at shortening hospital stay in pediatric patients undergoing laparoscopic appendectomy for complicated acute appendicitis, yields outcomes that are not inferior to the standard therapeutic model in terms of the combined variable of adverse events within 30 days postoperatively (including postoperative abdominal abscess, peritonitis, surgical wound complications, reintervention, sepsis, or death).

Подробное описание

Complicated appendicitis is defined as the finding in the intraoperative study of a perforated, gangrenous or contaminated appendix with the presence of periappendicular abscess. Currently, the therapeutic approach for complicated appendicitis is based on monotherapy antibiotic management (except for drug allergies, appendicular peritonitis, immunosuppression or nosocomial acquisition) in the postoperative period, with a minimum duration of 5 days (intravenous treatment). Therefore, the minimum hospital stay in these patients is expected to be equal to or more than 5 days.

Acute appendicitis represents the most frequent cause of acute abdomen in pediatric patients older than two years. It affects approximately 80,000 children in the European Union, making appendectomy one of the most frequent non-elective pediatric interventions performed by pediatric surgeons.

In recent years, several ambispective studies have been carried out at national level applying new therapeutic models that allow shortening the hospital stay by applying more lax discharge criteria and reducing the duration of intravenous antibiotic treatment, without significant alterations in the rate of postoperative complications.

By reducing hospital stay, the fast-track model not only brings clinical benefits to patients, but also economic benefits to the healthcare system.

Вмешательства

• Препарат Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)
  Inpatient postoperative intravenous treatment according to the established protocol in each center for 3 days, followed of oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) for two more days at home
• Препарат Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center
  Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days

Первичные конечные точки

• Adverse events [Срок оценки: 30 days]

Вторичные конечные точки (9)

• Individualized incidence of adverse events [Срок оценки: 30 days]
• Hospital readmission rate [Срок оценки: 30 days]
• Adverse reactions related to antibiotic treatment [Срок оценки: 14 days]
• Need for percutaneous drainage [Срок оценки: 30 days]
• Quality of life measure [Срок оценки: day 2, and at 5, 14, and 30 postoperative days]
• Client Satisfaction Questionnaire (CSQ-18) [Срок оценки: day 5, and day 30]
• Procalcitonina value [Срок оценки: 3 days]
• Antibiotic consumption [Срок оценки: 30 days]
• Associated costs [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.

Критерии исключения

• Peritonitis with sepsis criteria. Catarrhal or phlegmonous appendicitis. History of cystic fibrosis, Crohn's disease, or transplant that may interfere with the usual postoperative course of laparoscopic appendectomy.

Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 7 центров

• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Germans Trias i Pujol — Badalona
• Hospital del Mar — Barcelona
• Hospital Sant Joan de Deu — Esplugues de Llobregat
• Hospital Universitario Dr. Josep Trueta — Girona
• Complejo Universitario Hospitalario de Santiago de Compostela — Santiago de Compostela
• Hospital Joan XXIII — Tarragona

Публикации

• 17th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT). Eur J Clin Pharmacol. 2025 Jun;81(Suppl 1):1-63. doi: 10.1007/s00228-025-03859-x. No abstract available. PMID 40493059

Идентификаторы

NCT: NCT05761080 · IIBSP-FAS-2020-120 · 2025-520777-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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