Health TrialsbyHealthPanel

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

ConditionsLaparoscopic AppendectomyComplicated AppendicitisPeriappendicular Abscess
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-17
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

To evaluate whether a postoperative therapeutic strategy, Fast Track, aimed at shortening hospital stay in pediatric patients undergoing laparoscopic appendectomy for complicated acute appendicitis, yields outcomes that are not inferior to the standard therapeutic model in terms of the combined variable of adverse events within 30 days postoperatively (including postoperative abdominal abscess, peritonitis, surgical wound complications, reintervention, sepsis, or death).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.

Disqualifiers

Patients requiring admission to the ICU with vasoactive support. Catarrhal or phlegmonous appendicitis. History of cystic fibrosis, Crohn's disease, or transplant that may interfere with the usual postoperative course of laparoscopic appendectomy. Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)

    Drug

    Inpatient postoperative intravenous treatment according to the established protocol in each center for 3 days, followed of oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) for two more days at home

  • Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center

    Drug

    Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days

Treatment groups

772 Participants
are divided into 2 treatment groups
Group A: Experimental branchExperimental treatment 1 intervention
Group B: Control branchActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

The primary outcome measure will be the composite variable "adverse events" occurring within the first 30 postoperative days, defined as the occurrence of any of the following events: intra-abdominal abscess, peritonitis, surgical wound complications, reoperation, sepsis, or death.

Time frame
30 days

Secondary outcomes

1

Individualized incidence of adverse events

Individualized incidence of postoperative abdominal abscess, peritonitis, surgical wound complications (infection, hematoma, dehiscence, and seroma), reoperation, sepsis, and death during the 30-day follow-up period

Time frame
30 days
2

Hospital readmission rate

Monitoring the number of patients who are unexpectedly readmitted to the hospital after appendicectomy

Time frame
30 days
3

Adverse reactions related to antibiotic treatment

Adverse reactions related to antibiotic treatment up to 14 days of follow-up

Time frame
14 days
4

Need for percutaneous drainage

Need for percutaneous drainage after surgery during the first 30 postoperative days.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
Apply now