Clinical trial NCT05761080: Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Official title: Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Laparoscopic Appendectomy
Complicated Appendicitis
Periappendicular Abscess
Keywords: Complicated appendicitis
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 158
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative Complication Rate
timeFrame: 30 days
Secondary outcomes:
measure: Hospital readmission rate
timeFrame: 30 days
measure: Procalcitonina value
timeFrame: 3 days
measure: Antibiotic consumption
timeFrame: 30 days
measure: Associated costs
timeFrame: 30 days
measure: Quality of life measure
timeFrame: 30 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: