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Clinical trial

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

ID
Name
IIBSP-FAS-2020-120
Description
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.
Trial arms
Trial start
2021-04-22
Estimated PCD
2026-09-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Control branch
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.
Arms:
Experimental branch
Size
158
Primary endpoint
Postoperative Complication Rate
30 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 158, 'type': 'ESTIMATED'}}
Updated at
2023-03-31

1 organization

1 product

3 indications

Organization
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Product
Amoxicillin Clavulanic acid
Indication
Laparoscopic Appendectomy
Indication
Appendicitis
Indication
Periappendicular Abscess