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New treatment option for Laparoscopic Appendectomy
Official title Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
ClinicalTrials.gov ID: NCT05761080
What this study is testing
What is Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)?
Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for laparoscopic appendectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with...
You likely can't join if
- Peritonitis with sepsis criteria. Catarrhal or phlegmonous appendicitis. History of cystic fibrosis, Crohn's disease, or transplant that may...
- Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
- Badalona, Spain
- Barcelona, Spain
- Esplugues de Llobregat, Spain
- Girona, Spain
- Santiago de Compostela, Spain
- Tarragona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain; Badalona, Spain; Barcelona, Spain; Esplugues de Llobregat, Spain; Girona, Spain; Santiago de Compostela, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.