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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carlos Leganes, MD; Phone Number: +34935537635; Email: cleganes@santpau.cat
• Study Contact Backup: Name: Claudia Delgado, MD; Phone Number: +34935537636; Email: cdelgadoe@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Carlos Leganes, MD; Phone Number: +34935537634; Email: cleganes@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Study Population

The population consists of patients diagnosed with acute appendicitis, clinical or radiological, in a pediatric patient. The total number of patients to be enrolled in this project will be 158 patients, equally distributed between the two groups (79 cases/group). The sample size has been calculated to demonstrate no superiority in the rate of abdominal abscesses in the Fast-Track group versus the conventional Management group. A loss-to-follow-up series of 5% expected to be recruited over a period of 2 to 3 years is assumed.

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative Complication Rate	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Complicated appendicitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: IIBSP-FAS-2020-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No