Laparoscopic AppendectomyPhase 4FTAANCT05761080
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
A Phase 4 study testing Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) and Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center in people with Laparoscopic Appendectomy and Complicated Appendicitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 12 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Laparoscopic Appendectomy, Complicated Appendicitis, Periappendicular Abscess
- What is being tested?
- Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) and Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 12 sitesSpain
- Study dates
- 22 Apr 2021to Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Spain12 sites, 11 recruiting
- Recruiting
Hospital Germans Trias i Pujol
Badalona
Alba Martin Lluis, MD, PhD, +34 934651200, martin.cirped@gmail.com
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Carlos Leganes, MD, +34935537634, cleganes@santpau.cat
- Recruiting
Hospital del Mar
Barcelona
Estela Membrilla Fernandez, MD, PhD, +34 932483207, emembrilla@psmar.cat
- Not yet recruiting
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Córdoba, 14004
Javier Murcia, MD, +34957010000, jmurciapascual@gmail.com
- Recruiting
Hospital Sant Joan de Deu
Esplugues de Llobregat
Pedro Palafon Belver, MD, PhD, +34 932532100, pedro.palafon@sjd.es
- Recruiting
Hospital Universitario Dr. Josep Trueta
Girona
Enrique Antonio Bordon Cabrera, MD, PhD, +34 972940200 ext. 2292, eabordon.girona.ics@gencat.cat
- Not yet recruiting
Hospital Arnau de Villanova de Lleida
Lleida, Lleida, 25198
Rocío Soledad Gutierrez, MD, +34973 24 8100, rociogutierrez1@hotmail.com
- Not yet recruiting
Hoapital Clínico San Carlos
Madrid, Madrid, 28040
Luis Felipe Ávila, MD, PhD, +34 913303000, luisfelipe.avila@salud.madrid.org
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
- Recruiting
Complejo Universitario Hospitalario de Santiago de Compostela
Santiago de Compostela
Lorena Miguez Fortes, MD, PhD, +34 981950000, lorena.maria.miguez.cortes@sergas.es
- Not yet recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Isabel Casal, MD, PhD, +34955012000, isabelcasalbe@gmail.com
- Recruiting
Hospital Joan XXIII
Tarragona
Carlos Pueyo Gil, MD, PhD, +34 977295800, pueyogil@gmail.com
About this study
Official title: Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial
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).
Read the 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.
- Being tested
- Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day), Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center
- Keywords
- Complicated appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)Drug
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 centerDrug
Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental branch | Experimental | Inpatient postpoperative intravenous antibiotic 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 Receives: Drug: Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) |
| Control branch | Active comparator | Inpatient postoperative intravenous treatment according to the protocol established in each center, lasting 5 days Receives: Drug: Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
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.
Measured: 30 days
Secondary outcomes (9)
Individualized incidence of adverse events
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
Measured: 30 days
Hospital readmission rate
Monitoring the number of patients who are unexpectedly readmitted to the hospital after appendicectomy
Measured: 30 days
Adverse reactions related to antibiotic treatment
Adverse reactions related to antibiotic treatment up to 14 days of follow-up
Measured: 14 days
Need for percutaneous drainage
Need for percutaneous drainage after surgery during the first 30 postoperative days.
Measured: 30 days
Quality of life measure
Measured by EQ-5D-5L questionnaire
Measured: day 2, and at 5, 14, and 30 postoperative days
Client Satisfaction Questionnaire (CSQ-18)
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).
Measured: day 5, and day 30
Procalcitonina value
Procalcitonin levels on the third postoperative day, measured by blood tests according to protocol.
Measured: 3 days
Antibiotic consumption
Medications used to treat complications: the antibiotic used, its route of administration, and the duration of treatment
Measured: 30 days
Associated costs
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start22 Apr 2021
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic AppendectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, open label, paralell clinical trial
- Masking
- None (open label)
- Enrolment
- 772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª José Martínez Zapata, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Maria Jose Martinez-Zapata, MD, PhD, Study chair, Institut de Recerca Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761080
- Sponsor's protocol ID
- IIBSP-FAS-2020-120
- Other IDs
- 2025-520777-39-00, 2025
- Acronym
- FTAA
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
17th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT). Eur J Clin Pharmacol. 2025 Jun;81(Suppl 1):1-63. doi: 10.1007/s00228-025-03859-x. No abstract available.
PubMed 40493059
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial
- ClinicalTrials.gov ID
- NCT05761080
- Acronym / sponsor ID
- FTAA / IIBSP-FAS-2020-120
- Keywords
- Complicated appendicitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric, open label, paralell clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental branch | Experimental | Drug: Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)Inpatient postpoperative intravenous antibiotic 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 |
| Control branch | Active comparator | Drug: Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each centerInpatient postoperative intravenous treatment according to the protocol established in each center, lasting 5 days |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral 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 | Drug | Experimental branch |
| Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each centerInpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days | Drug | Control branch |
Primary outcome
Adverse events
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.
9 secondary outcomes
Individualized incidence of adverse events
Time frame: 30 days
Hospital readmission rate
Time frame: 30 days
Adverse reactions related to antibiotic treatment
Time frame: 14 days
Need for percutaneous drainage
Time frame: 30 days
Quality of life measure
Time frame: day 2, and at 5, 14, and 30 postoperative days
Client Satisfaction Questionnaire (CSQ-18)
Time frame: day 5, and day 30
Procalcitonina value
Time frame: 3 days
Antibiotic consumption
Time frame: 30 days
Associated costs
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 4049305917th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT). Eur J Clin Pharmacol. 2025 Jun;81(Suppl 1):1-63. doi: 10.1007/s00228-025-03859-x. No abstract available.
- Abstract book. P374, S43Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Laparoscopic Appendectomy
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Jose Martinez-Zapata, MD, PhD study chair
Institut de Recerca Sant Pau
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) and Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center in people with Laparoscopic Appendectomy and Complicated Appendicitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Jose Martinez-Zapata, MD, PhD (+34935537901, mmartinezz@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05761080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.