FTAA: Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Study Details
Study Description
Brief Summary
Evaluate the application of the new therapeutic model post Fast Track surgery, in complicated acute appendicitis, in pediatric population on the rate of complications postoperative in the form of abdominal abscesses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
IComplicated appendicitis is defined as the finding in the intraoperative study of a perforated, gangrenous or contaminated appendix with the presence of periappendicular abscess. In November 2005, the synthesis of an "EVIDENCE-BASED CLINICAL PRACTICE GUIDE FOR ACUTE APPENDICITIS IN PEDIATRICS" at the Hospital Vall d'Hebron, the result of a committee of experts in the field. This protocol has been the guideline for our center in recent years.
Currently, the therapeutic approach 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.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental branch Patients will be included in the study during the anesthetic surgery evaluation. Randomization of patients on the third postoperative day. If belonging to the FT group: Application of discharge criteria in the experimental branch at 72 hours post-surgery, administration of oral antibiotic therapy with a similar spectrum to that of the control group for a total of 5 days and sending the patient home with oral analgesia. Amoxicillin - clavulanic acid Dose: 100mg/Kg/day every 8 hours Oral route, oral Augmentin, for 5 days. Regardless of the group to which the patient belongs, there will be a follow-up at 5, 7 and 30 days after telephone discharge. In addition, there will be a face-to-face visit 2 weeks after the intervention. The approximate duration of the patient under study will be 35 days. |
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| Control branch Patients will be included in the study during the anesthetic surgery evaluation. The patient will be randomized at the time of informed consent to know the postoperative guideline to be used. Randomization of patients on postoperative day 3. If it belongs to the control group: Application of discharge criteria in control branch 5 days postoperative, according to current clinic guidelines. Amoxicillin - clavulanic acid. Dose: 100mg/Kg/day every 8 hours, intravenous, Augmentin Iv. Duration of treatment: 5 days Regardless of the group to which you belong, you will be followed up 5, 7 and 30 days after telephone discharge. In addition, an in-person visit will be made 2 weeks after the intervention. The approximate duration of the patient under study will be 35 days. |
Outcome Measures
Primary Outcome Measures
- Postoperative Complication Rate [30 days]
Secondary Outcome Measures
- Hospital readmission rate [30 days]
- Procalcitonina value [3 days]
Blood sample
- Antibiotic consumption [30 days]
- Associated costs [30 days]
- Quality of life measure [30 days]
Measured by EQ-5D-5L questionnaire
Eligibility Criteria
Criteria
Inclusion criteria:
- Ages 2 to 16 years Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. 72 hours postoperative. Leukocyte count and C-reactive protein at 72 hours post-surgery increased (minimum 20% with respect to the preoperative baseline). Complete oral tolerance. Pain controlled with conventional analgesia.Afebrile (more than 24 hours).
Exclusion criteria:
- History of cystic fibrosis, Crohn's disease, transplant or appendicitis. Chronic requiring elective technique. Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
Sponsors and Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIBSP-FAS-2020-120