Complicated Appendicitis, Laparoscopic Appendectomy, Periappendicular Abscess
Conditions
Keywords
Complicated appendicitis
Brief summary
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).
Detailed description
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.
Interventions
DRUGOral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)
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
DRUGInpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center
Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentric, open label, paralell clinical trial
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individualized incidence of adverse events | 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 |
| Hospital readmission rate | 30 days | Monitoring the number of patients who are unexpectedly readmitted to the hospital after appendicectomy |
| Adverse reactions related to antibiotic treatment | 14 days | Adverse reactions related to antibiotic treatment up to 14 days of follow-up |
| Need for percutaneous drainage | 30 days | Need for percutaneous drainage after surgery during the first 30 postoperative days. |
| Quality of life measure | day 2, and at 5, 14, and 30 postoperative days | Measured by EQ-5D-5L questionnaire |
| Client Satisfaction Questionnaire (CSQ-18) | 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). |
| Procalcitonina value | 3 days | Procalcitonin levels on the third postoperative day, measured by blood tests according to protocol. |
| Antibiotic consumption | 30 days | Medications used to treat complications: the antibiotic used, its route of administration, and the duration of treatment |
| Associated costs | 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. |
Countries
Spain
Contacts
CONTACTMaria Jose Martinez-Zapata, MD, PhD
CONTACTCarlos Leganés Villanueva, MD
STUDY_CHAIRMaria Jose Martinez-Zapata, MD, PhD
Institut de Recerca Sant Pau
Outcome results
None listed