Valid MeSH ConditionsAPPX_TEXTBOOKNCT06765044
Textbook Outcomes in Urgent Appendectomy
An observational study of Valid MeSH Conditions, run by Hospital del Mar.
Trial summary
A "textbook outcome" patient is defined as one whose surgical course is uneventful, with no complications, readmissions, or mortality. There is a lack of published research regarding textbook outcomes with an acute appendicitis that are treated with an appendectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valid MeSH Conditions
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 15 Feb 2025
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the admissions with diagnostic of Acute Appendicitis in an University Hospital
Who may be able to join
- Acute Appendicits in older than 18 years old
- Acute Appendicitis that needs appendectomy
Who cannot join
- Age under 18 years old
- Other diagnostic than an Acute Appendicitis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ana Maria González Castillo PhD, PhD contact
About this study
Official title: Textbook Outcomes of Surgical Treatment of Acute Appendicitis
A "textbook outcome" patient is defined as one whose surgical course is uneventful, with no complications, readmissions, or mortality. There is a lack of published research regarding textbook outcomes with an acute appendicitis that are treated with an appendectomy.
Read the detailed description
The objective of this study is to analyze the attainment of textbook outcomes (TO) in patients undergoing urgent appendicectomy (UA) for acute appendicitis and to identify the factors associated with achieving TO.
- Conditions
- Valid MeSH Conditions
- Keywords
- Textbook Outcomes, Laparoscopy, Acute Appendicitis, Open Surgery, Urgent Appendectomy
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook Outcomes
Classical assessments, focused solely on mortality and morbidity, are increasingly considered insufficient. A more comprehensive approach, using composite measures, offers a more accurate evaluation, providing a multidimensional view and patient-centred healthcare appraisal. The textbook outcome (TO) is the most used objective composite measure to compare surgical quality across centres
Measured: 2022-2024
Secondary outcomes (9)
Appendectomy in less than 24h
From diagnostic of Acute Appendicitus to Surgical Treatment should be less than 24h
Measured: 2022-2024
Hospital Stay less than 5 days
Optimal hospital stay should be less than 5 days
Measured: 2022-2024
Intraoperative incidences
Intraoperative bleeding, perforation of the appendix, iatrogenic injury to other structures
Measured: 2022-2024
Short antibiotics treatment
Less than 72h of antibiotic treatment
Measured: 2022-2024
Patient comorbidities
Charlson Comorbidity Index
Measured: 2022-2024
Surgical Risk
ASA Scoring System
Measured: 2022-2024
Intraoperative appendicitis gradding
AAST classification AAST I: Acutely inflamed appendix, intact. AAST II:Gangrenous appendix, intact AAST III:Above, with evidence of local contamination AAST IV:Above, with abscess or phlegmon in region of appendix AAST V:Above, with addition of generalized purulent contamination away from appendix
WSES Classification:
Grade- 0 (normal looking) Grade-1 (inflamed) Grade- 2A and 2B (necrosis) Grade- 3A - 3B - 3C (perforated - inflammatory tumor) Grade- 4 (perforate - diffuse peritonitis)
Measured: 2022-2024
Postperative complications
Clavien Dindo and CCI (https://www.cci-calculator.com/)
Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.
Grade II:Requiring pharmacological treatment with drugs other than such allowed for Grade I Grade III:Requiring surgical, endoscopic or radiological intervention. Grade IV:Life-threatening complication (including CNS complications)* requiring IC/ICU-management with single or multiorgan disfunction.
Grade V: Death of a patient
Measured: 2022-2024
Readmision index
Percentage of readmission
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valid MeSH ConditionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María González Castillo, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765044
- Sponsor's protocol ID
- Appendicitis Textbook Outomes
- Other IDs
- CEIm number
- Acronym
- APPX_TEXTBOOK
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes