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Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics (FTAA)

Primary Purpose

Laparoscopic Appendectomy, Complicated Appendicitis, Periappendicular Abscess

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Amoxicillin clavulanic acid IV during hospitalization
Amoxicillin clavulanic acid IV 3 days and PO until day 5
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Appendectomy focused on measuring Complicated appendicitis

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de la Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental branch

Control branch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative Complication Rate

Secondary Outcome Measures

Hospital readmission rate
Procalcitonina value
Blood sample
Antibiotic consumption
Associated costs
Quality of life measure
Measured by EQ-5D-5L questionnaire

Full Information

First Posted
February 27, 2023
Last Updated
March 29, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT05761080
Brief Title
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Acronym
FTAA
Official Title
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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. 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. By reducing hospital stay, the fast-track model not only brings clinical benefits to patients, but also economic benefits to the healthcare system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Appendectomy, Complicated Appendicitis, Periappendicular Abscess
Keywords
Complicated appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental branch
Arm Type
Experimental
Arm Description
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.
Arm Title
Control branch
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin clavulanic acid IV during hospitalization
Intervention Description
Amoxicillin clavulanic acid IV 5 days during hospitalization. Application of discharge criteria at 5 postoperative days, according to guidelines current clinic.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin clavulanic acid IV 3 days and PO until day 5
Intervention Description
Amoxicillin clavulanic acid IV 3 days during hospitalization and at discharge Amoxicillin clavulanic acid PO until day 5. Application of discharge criteria at 72 postoperative hours, administering oral antibiotic therapy with a spectrum similar to that of the control group total of 5 days and sending the patient home with oral analgesia.
Primary Outcome Measure Information:
Title
Postoperative Complication Rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital readmission rate
Time Frame
30 days
Title
Procalcitonina value
Description
Blood sample
Time Frame
3 days
Title
Antibiotic consumption
Time Frame
30 days
Title
Associated costs
Time Frame
30 days
Title
Quality of life measure
Description
Measured by EQ-5D-5L questionnaire
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Leganes, MD
Phone
+34935537635
Email
cleganes@santpau.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Delgado, MD
Phone
+34935537636
Email
cdelgadoe@santpau.cat
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Leganes, MD
Phone
+34935537634
Email
cleganes@santpau.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

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