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Not yet recruitingNCT06765044APPX_TEXTBOOKUpdated Jan 9, 2025

Textbook Outcomes in Urgent Appendectomy

An observational study in Valid MeSH Conditions, sponsored by Hospital del Mar. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Hospital del Mar · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Valid MeSH Conditions

Browse trials for

Keywords

  • Textbook Outcomes
  • Laparoscopy
  • Acute Appendicitis
  • Open Surgery
  • Urgent Appendectomy
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In context

Appendicitis

419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 151 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Hospital del Mar is the lead sponsor of 45 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All the admissions with diagnostic of Acute Appendicitis in an University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute Appendicits in older than 18 years old
  • Acute Appendicitis that needs appendectomy

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years old
  • Other diagnostic than an Acute Appendicitis
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 2022-2024

Secondary outcomes

  1. Appendectomy in less than 24h

    From diagnostic of Acute Appendicitus to Surgical Treatment should be less than 24h

    Time frame: 2022-2024

  2. Hospital Stay less than 5 days

    Optimal hospital stay should be less than 5 days

    Time frame: 2022-2024

  3. Intraoperative incidences

    Intraoperative bleeding, perforation of the appendix, iatrogenic injury to other structures

    Time frame: 2022-2024

  4. Short antibiotics treatment

    Less than 72h of antibiotic treatment

    Time frame: 2022-2024

  5. Patient comorbidities

    Charlson Comorbidity Index

    Time frame: 2022-2024

  6. Surgical Risk

    ASA Scoring System

    Time frame: 2022-2024

  7. 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)

    Time frame: 2022-2024

  8. 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

    Time frame: 2022-2024

  9. Readmision index

    Percentage of readmission

    Time frame: 2022-2024

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

Time frame: 2025-2026

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Jan 2025, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2024
First posted
Jan 9, 2025
StartEst.
Jan 15, 2025
Primary completionEst.
Jan 15, 2025
CompletionEst.
Feb 15, 2025
Last update
Jan 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06765044
Lead sponsor
Hospital del Mar
Responsible party
Ana María González Castillo (Principal Investigator, Hospital del Mar) — Principal investigator
First posted
Jan 9, 2025
Start date
Jan 15, 2025 (estimated)
Primary completion
Jan 15, 2025 (estimated)
Completion
Feb 15, 2025 (estimated)
Last update
Jan 9, 2025

Study contacts

Ana Maria Gonzalez Castillo PhD, PhD
Contact
amgonzalezcastillo@gmail.com
+34665126866
Ana Maria González Castillo PhD, PhD
Contact
amgonzalezcastillo@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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