NCT06765044

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

December 17, 2024

Last Update Submit

January 2, 2025

Conditions

Keywords

Textbook OutcomesLaparoscopyAcute AppendicitisOpen SurgeryUrgent Appendectomy

Outcome Measures

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

    2022-2024

Secondary Outcomes (9)

  • Appendectomy in less than 24h

    2022-2024

  • Hospital Stay less than 5 days

    2022-2024

  • Intraoperative incidences

    2022-2024

  • Short antibiotics treatment

    2022-2024

  • Patient comorbidities

    2022-2024

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Central Study Contacts

Ana Maria Gonzalez Castillo PhD, PhD

CONTACT

Ana Maria González Castillo PhD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2024

First Posted

January 9, 2025

Study Start

January 15, 2025

Primary Completion

January 15, 2025

Study Completion

February 15, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
2025-2026