Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Contact Information
Primary
Carlos Leganes, MD
cleganes@santpau.cat
+34935537635
Backup
Claudia Delgado, MD
cdelgadoe@santpau.cat
+34935537636
Time Frame
Start Date: 2021-04-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 158
Treatments
Experimental: Experimental 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 patient belong to the Fast Track group:~Application of discharge criteria in the experimental branch at 72 hours post-surgery, and administration of oral antibiotic therapy: Amoxicillin - clavulanic acid, dose: 100mg/Kg/day every 8 hours for a total of 5 days.~There will be a follow-up at 5, 7 and 30 days after discharge. In addition, there will be a face-to-face visit 2 weeks after the intervention.
Active_comparator: 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 patient belongs to the control group:~Application of discharge criteria in control branch 5 days postoperative, according to current clinic guidelines. Administration of Amoxicillin - clavulanic acid, dose: 100mg/Kg/day every 8 hours, intravenous during 5 days~There will be a follow-up at 5, 7 and 30 days after discharge. In addition, there will be a face-to-face visit 2 weeks after the intervention.
Related Therapeutic Areas
Sponsors
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau