Textbook Outcomes in Urgent Appendectomy (APPX_TEXTBOOK)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Valid MeSH Conditions

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Ana Maria Gonzalez Castillo PhD, PhD; Phone Number: +34665126866; Email: amgonzalezcastillo@gmail.com
• Study Contact Backup: Name: Ana Maria González Castillo PhD, PhD; Email: amgonzalezcastillo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appendectomy in less than 24h	From diagnostic of Acute Appendicitus to Surgical Treatment should be less than 24h	2022-2024
Hospital Stay less than 5 days	Optimal hospital stay should be less than 5 days	2022-2024
Intraoperative incidences	Intraoperative bleeding, perforation of the appendix, iatrogenic injury to other structures	2022-2024
Short antibiotics treatment	Less than 72h of antibiotic treatment	2022-2024
Patient comorbidities	Charlson Comorbidity Index	2022-2024
Surgical Risk	ASA Scoring System	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)	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	2022-2024
Readmision index	Percentage of readmission	2022-2024

Collaborators and Investigators

• Sponsor: Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Acute Appendicitis; Laparoscopy; Open Surgery; Textbook Outcomes; Urgent Appendectomy
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: Appendicitis Textbook Outomes; CEIm number (Other Identifier: Hospital del Mar)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2025-2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No