Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Complicated Appendicitis Clinical Trial

— FTAA  

Official title:

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761080
• Other study ID #: IIBSP-FAS-2020-120
• Status: Recruiting
• Phase: Phase 4
• Start date: April 22, 2021
• Est. completion date: December 2026

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Carlos Leganes, MD
• Phone: +34935537635
• Email: cleganes[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the application of the new therapeutic model post Fast Track surgery, in complicated acute appendicitis, in pediatric population on the rate of complications postoperative in the form of abdominal abscesses.

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. In November 2005, the synthesis of an "Evidence-based clinical practice guide for acute appendicitis in pediatrics" at the Hospital Vall d'Hebron, the result of a committee of experts in the field. This protocol has been the guideline for our center in recent years. Currently, the therapeutic approach 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion criteria:

• Ages 2 to 16 years Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. 72 hours postoperative. Leukocyte count and C-reactive protein at 72 hours post-surgery increased (minimum 20% with respect to the preoperative baseline). Complete oral tolerance. Pain controlled with conventional analgesia.Afebrile (more than 24 hours).

Exclusion criteria:

• History of cystic fibrosis, Crohn's disease, transplant or appendicitis. Chronic requiring elective technique. Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.

Related Conditions & MeSH terms

• Appendicitis
• Complicated Appendicitis
• Laparoscopic Appendectomy
• Periappendicular Abscess

Intervention

Drug:
• Amoxicillin clavulanic acid IV during hospitalization
Amoxicillin clavulanic acid IV 5 days during hospitalization. Application of discharge criteria at 5 postoperative days, according to guidelines current clinic.
• Amoxicillin clavulanic acid IV 3 days and PO until day 5
Amoxicillin clavulanic acid IV 3 days during hospitalization and at discharge Amoxicillin clavulanic acid PO until day 5. Application of discharge criteria at 72 postoperative hours, administering oral antibiotic therapy with a spectrum similar to that of the control group total of 5 days and sending the patient home with oral analgesia.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Complication Rate		30 days
Secondary	Hospital readmission rate		30 days
Secondary	Procalcitonina value	Blood sample	3 days
Secondary	Antibiotic consumption		30 days
Secondary	Associated costs		30 days
Secondary	Quality of life measure	Measured by EQ-5D-5L questionnaire	30 days