Textbook Outcome in Adrenal Neoplasms

Outcome Assessment Clinical Trial

Official title:

A Novel Study, Textbook Outcome in Adrenal Neoplasms: Observational Study in a Endocrine Surgical Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05888753
• Other study ID #: 05/2023
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2023
• Source: Hospital General Universitario de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

BACKGROUND:

Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for adrenal neoplasms.

MATERIAL AND METHODS:

Retrospective study of all patients undergoing scheduled adrenal neoplasms surgery at a Spanish university hospital from September January 2010 to December 2022. Emergency surgeries were excluded. The variables included in the definition of TO were: R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.

The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled adrenal neoplasms resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators compare the group of patients who achieve a TO result with the group of patients who do not. A univariable and multivariable analysis will be carry out in order to indentified the variables associated with TO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective adrenal resection were eligible for the study

Exclusion Criteria:

• Age under 18 years

• Emergency surgery

• Resections of other organs in the same surgery.

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Neoplasm
• Neoplasms
• Outcome Assessment

Intervention

Procedure:
• Adrenalectomy
Scheduled adrenal surgery

Locations

Country	Name	City	State
Spain	Juan Jesús Rubio García	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Textbook Outcome	Analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled adrenal resection. Number of Participants with R0 resection, no Clavien-Dindo =IIIa complications, no prolonged stay (	January 2010 to December 2022