Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics (FTAA)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Complicated Appendicitis; Laparoscopic Appendectomy; Periappendicular Abscess
• Intervention / Treatment: Drug: Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day); Drug: Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 772
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Maria Jose Martinez-Zapata, MD, PhD; Phone Number: +34935537901; Email: mmartinezz@santpau.cat
• Study Contact Backup: Name: Carlos Leganés Villanueva, MD; Phone Number: +34935537634; Email: cleganes@santpau.cat

Study Locations

• Spain
  • Badalona, Spain
    • Recruiting
    • Hospital Germans Trias i Pujol
    • Contact: Alba Martin Lluis, MD, PhD; Phone Number: +34 934651200; Email: martin.cirped@gmail.com
  • Barcelona, Spain
    • Recruiting
    • Hospital del Mar
    • Contact: Estela Membrilla Fernandez, MD, PhD; Phone Number: +34 932483207; Email: emembrilla@psmar.cat
  • Esplugues de Llobregat, Spain
    • Recruiting
    • Hospital Sant Joan de Deu
    • Contact: Pedro Palafon Belver, MD, PhD; Phone Number: +34 932532100; Email: pedro.palafon@sjd.es
  • Girona, Spain
    • Recruiting
    • Hospital Universitario Dr. Josep Trueta
    • Contact: Enrique Antonio Bordon Cabrera, MD, PhD; Phone Number: 2292 +34 972940200; Email: eabordon.girona.ics@gencat.cat
  • Santiago de Compostela, Spain
    • Recruiting
    • Complejo Universitario Hospitalario de Santiago de Compostela
    • Contact: Lorena Miguez Fortes, MD, PhD; Phone Number: +34 981950000; Email: lorena.maria.miguez.cortes@sergas.es
  • Tarragona, Spain
    • Recruiting
    • Hospital Joan XXIII
    • Contact: Carlos Pueyo Gil, MD, PhD; Phone Number: +34 977295800; Email: pueyogil@gmail.com
  • Barcelona
    • Barcelona, Barcelona, Spain
      • Recruiting
      • Hospital de la Santa Creu i Sant Pau
      • Contact: Carlos Leganes, MD; Phone Number: +34935537634; Email: cleganes@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Study Population

The population consists of patients diagnosed with acute appendicitis, clinical or radiological, in a pediatric patient. The total number of patients to be enrolled in this project will be 158 patients, equally distributed between the two groups (79 cases/group). The sample size has been calculated to demonstrate no superiority in the rate of abdominal abscesses in the Fast-Track group versus the conventional Management group. A loss-to-follow-up series of 5% expected to be recruited over a period of 2 to 3 years is assumed.

Description

Inclusion criteria:

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

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental branch; Inpatient postpoperative intravenous antibiotic 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	Drug: 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
Active Comparator: Control branch; Inpatient postoperative intravenous treatment according to the protocol established in each center, lasting 5 days	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	The primary outcome measure will be the composite variable "adverse events" occurring within the first 30 postoperative days, defined as the occurrence of any of the following events: intra-abdominal abscess, peritonitis, surgical wound complications, reoperation, sepsis, or death.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individualized incidence of adverse events	Individualized incidence of postoperative abdominal abscess, peritonitis, surgical wound complications (infection, hematoma, dehiscence, and seroma), reoperation, sepsis, and death during the 30-day follow-up period	30 days
Hospital readmission rate	Monitoring the number of patients who are unexpectedly readmitted to the hospital after appendicectomy	30 days
Adverse reactions related to antibiotic treatment	Adverse reactions related to antibiotic treatment up to 14 days of follow-up	14 days
Need for percutaneous drainage	Need for percutaneous drainage after surgery during the first 30 postoperative days.	30 days
Quality of life measure	Measured by EQ-5D-5L questionnaire	day 2, and at 5, 14, and 30 postoperative days
Client Satisfaction Questionnaire (CSQ-18)	Patient and/or family satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-18) on postoperative day 5 and at the end of follow-up (30 postoperative days).	day 5, and day 30
Procalcitonina value	Procalcitonin levels on the third postoperative day, measured by blood tests according to protocol.	3 days
Antibiotic consumption	Medications used to treat complications: the antibiotic used, its route of administration, and the duration of treatment	30 days
Associated costs	Costs derived from the hospital stay and other direct healthcare costs: quantification of healthcare resources used in laboratory tests, imaging tests, medications used, disposable materials, other complementary tests, and costs of complications.	30 days

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Study Chair: Maria Jose Martinez-Zapata, MD, PhD, Institut de Recerca Sant Pau

Publications and helpful links

General Publications

• 17th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT). Eur J Clin Pharmacol. 2025;81(Suppl 1):1-63. doi:10.1007/s00228-025-03859-x. Poster 374.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Complicated appendicitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Amides; Drug Combinations; Penicillin G; beta-Lactams; Lactams; Clavulanic Acid; Clavulanic Acids; Ampicillin; Penicillins; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: IIBSP-FAS-2020-120; 2025-520777-39-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No