NCT Number: NCT05761080
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).
Interested in participating?
Request Info2 year–17 year
All sexes
Interventional
Phase 4
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.
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
Time frame: 30 days
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 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
Monitoring the number of patients who are unexpectedly readmitted to the hospital after appendicectomy
Time frame: 14 days
Adverse reactions related to antibiotic treatment up to 14 days of follow-up
Time frame: 30 days
Need for percutaneous drainage after surgery during the first 30 postoperative days.
Time frame: day 2, and at 5, 14, and 30 postoperative days
Measured by EQ-5D-5L questionnaire
Time frame: day 5, and day 30
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: 3 days
Procalcitonin levels on the third postoperative day, measured by blood tests according to protocol.
Time frame: 30 days
Medications used to treat complications: the antibiotic used, its route of administration, and the duration of treatment
Time frame: 30 days
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.
Contact information is provided by the study sponsor or research team.
Carlos Leganés Villanueva, MD
CONTACT
Maria Jose Martinez-Zapata, MD, PhD
CONTACT
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Other
Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial
Acronym: FTAA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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