Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

NCT ID: NCT05761080

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2027-12-31

Brief 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.

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. 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.

Conditions

Laparoscopic Appendectomy; Complicated Appendicitis; Periappendicular Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental branch

Patients will be included in the study during the anesthetic surgery evaluation.

The patient will be randomized at the time of informed consent to know the postoperative guideline to be used.

Randomization of patients on postoperative day 3.

If patient belong to the Fast Track group:

Application of discharge criteria in the experimental branch at 72 hours post-surgery, and administration of oral antibiotic therapy: Amoxicillin - clavulanic acid, dose: 100mg/Kg/day every 8 hours for a total of 5 days.

There will be a follow-up at 5, 7 and 30 days after discharge. In addition, there will be a face-to-face visit 2 weeks after the intervention.

Group Type: EXPERIMENTAL

Amoxicillin clavulanic acid IV 3 days and PO until day 5

Intervention Type: DRUG

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.

Control branch

Patients will be included in the study during the anesthetic surgery evaluation.

The patient will be randomized at the time of informed consent to know the postoperative guideline to be used.

Randomization of patients on postoperative day 3.

If patient belongs to the control group:

Application of discharge criteria in control branch 5 days postoperative, according to current clinic guidelines. Administration of Amoxicillin - clavulanic acid, dose: 100mg/Kg/day every 8 hours, intravenous during 5 days

There will be a follow-up at 5, 7 and 30 days after discharge. In addition, there will be a face-to-face visit 2 weeks after the intervention.

Group Type: ACTIVE_COMPARATOR

Amoxicillin clavulanic acid IV during hospitalization

Intervention Type: DRUG

Amoxicillin clavulanic acid IV 5 days during hospitalization. Application of discharge criteria at 5 postoperative days, according to guidelines current clinic.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Jose Martinez-Zapata, MD, PhD

Role: STUDY_CHAIR

Institut de Recerca Sant Pau

Locations

Hospital Germans Trias i Pujol

Badalona, , Spain

Site Status: RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status: RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status: RECRUITING

Hospital Sant Joan de Deu

Esplugues de Llobregat, , Spain

Site Status: RECRUITING

Hospital Universitario Dr. Josep Trueta

Girona, , Spain

Site Status: RECRUITING

Complejo Universitario Hospitalario de Santiago de Compostela

Santiago de Compostela, , Spain

Site Status: RECRUITING

Hospital Joan XXIII

Tarragona, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Maria Jose Martinez-Zapata, MD, PhD

Role: CONTACT

mmartinezz@santpau.cat

+34935537901

Claudia Delgado, MD

Role: CONTACT

cdelgadoe@santpau.cat

+34935537636

Facility Contacts

Alba Martin Lluis, MD, PhD

Role: primary

martin.cirped@gmail.com

+34 934651200

Carlos Leganes, MD

Role: primary

cleganes@santpau.cat

+34935537634

Estela Membrilla Fernandez, MD, PhD

Role: primary

emembrilla@psmar.cat

+34 932483207

Pedro Palafon Belver, MD, PhD

Role: primary

pedro.palafon@sjd.es

+34 932532100

Enrique Antonio Bordon Cabrera, MD, PhD

Role: primary

eabordon.girona.ics@gencat.cat

+34 972940200 ext. 2292

Lorena Miguez Fortes, MD, PhD

Role: primary

lorena.maria.miguez.cortes@sergas.es

+34 981950000

Carlos Pueyo Gil, MD, PhD

Role: primary

pueyogil@gmail.com

+34 977295800

Other Identifiers

IIBSP-FAS-2020-120

Identifier Type: -

Identifier Source: org_study_id