A Phase 4 interventional study of Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) and Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center in Laparoscopic Appendectomy, Complicated Appendicitis and Periappendicular Abscess, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 12 sites in Spain. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 4, Interventional, and Treatment
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).
Complicated appendicitis is defined as the finding in the intraoperative study of a perforated, gangrenous or contaminated appendix with the presence of periappendicular abscess. Currently, the therapeutic approach for complicated appendicitis 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.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's planned enrollment of 772 is above the median of 110 across 120 interventional studies indexed under Abscess.
Browse Abscess studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
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Exclusion criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Inpatient postpoperative intravenous antibiotic 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
Drug: Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)
Inpatient postoperative intravenous treatment according to the protocol established in each center, lasting 5 days
Drug: Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center
Drug page: Amoxicillin-Potassium Clavulanate Combination
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 for 5 days
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
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
Hospital readmission rate
Monitoring the number of patients who are unexpectedly readmitted to the hospital after appendicectomy
Time frame: 30 days
Adverse reactions related to antibiotic treatment
Adverse reactions related to antibiotic treatment up to 14 days of follow-up
Time frame: 14 days
Need for percutaneous drainage
Need for percutaneous drainage after surgery during the first 30 postoperative days.
Time frame: 30 days
Quality of life measure
Measured by EQ-5D-5L questionnaire
Time frame: day 2, and at 5, 14, and 30 postoperative days
Client Satisfaction Questionnaire (CSQ-18)
Patient and/or family satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-18) on postoperative day 5 and at the end of follow-up (30 postoperative days).
Time frame: day 5, and day 30
Procalcitonina value
Procalcitonin levels on the third postoperative day, measured by blood tests according to protocol.
Time frame: 3 days
Antibiotic consumption
Medications used to treat complications: the antibiotic used, its route of administration, and the duration of treatment
Time frame: 30 days
Associated costs
Costs derived from the hospital stay and other direct healthcare costs: quantification of healthcare resources used in laboratory tests, imaging tests, medications used, disposable materials, other complementary tests, and costs of complications.
Time frame: 30 days
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Plan to share: No
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Studies of the drug tested here: Amoxicillin-Potassium Clavulanate Combination
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