- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05888753
Textbook Outcome in Adrenal Neoplasms
A Novel Study, Textbook Outcome in Adrenal Neoplasms: Observational Study in a Endocrine Surgical Unit.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Alicante, Spain, 03010
- Juan Jesús Rubio García
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Yes Textbook Outcome
Patients undergoing scheduled adrenal neoplasm surgery with a R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days
|
Scheduled adrenal surgery
|
No Textbook outcome
Patients undergoing scheduled colon cancer surgery without any of the following items: R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days
|
Scheduled adrenal surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Textbook Outcome
Time Frame: January 2010 to December 2022
|
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 (<P75), no readmissions, and no mortality in the first 30 days
|
January 2010 to December 2022
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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