Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Phase 4

Recruiting

• Conditions: Laparoscopic Appendectomy; Complicated Appendicitis; Periappendicular Abscess
• Interventions: Drug: Amoxicillin clavulanic acid IV during hospitalization; Drug: Amoxicillin clavulanic acid IV 3 days and PO until day 5

• Registration Number: NCT05761080
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study Start: 2021-04-22
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Status Verified: 2023-03
• Study First Posted: 2023-03-09
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control branch	Amoxicillin clavulanic acid IV during hospitalization	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.
Experimental branch	Amoxicillin clavulanic acid IV 3 days and PO until day 5	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Complication Rate	30 days

Secondary Outcome Measures

Name	Time	Method
Hospital readmission rate	30 days
Antibiotic consumption	30 days
Quality of life measure	30 days	Measured by EQ-5D-5L questionnaire
Procalcitonina value	3 days	Blood sample
Associated costs	30 days

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain