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

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

Status and phase: Enrolling; Phase 4

Conditions: Laparoscopic Appendectomy; Complicated Appendicitis; Periappendicular Abscess

Treatments: Drug: Amoxicillin clavulanic acid IV during hospitalization; Drug: Amoxicillin clavulanic acid IV 3 days and PO until day 5

Study type: Interventional

Funder types: Other

Identifiers

NCT05761080

IIBSP-FAS-2020-120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Experimental branch

Experimental group

Description:

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.

Treatment:

Drug: Amoxicillin clavulanic acid IV 3 days and PO until day 5

Control branch

Active Comparator group

Description:

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.

Treatment:

Drug: Amoxicillin clavulanic acid IV during hospitalization