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CompletedNCT05888753Updated Jun 22, 2023

Textbook Outcome in Adrenal Neoplasms

An observational study in Outcome Assessment and Adrenal Neoplasm, sponsored by Hospital General Universitario de Alicante. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Hospital General Universitario de Alicante · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
105
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Outcome Assessment
  • Adrenal Neoplasm
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 105 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Hospital General Universitario de Alicante is the lead sponsor of 12 studies on the registry; 5 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

Patients undergoing elective adrenal resection in the endorine surgical unit in public universitary hospital of alicante

Inclusion criteria

  • Patients undergoing elective adrenal resection were eligible for the study

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years
  • Emergency surgery
  • Resections of other organs in the same surgery.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
105 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Procedure: Adrenalectomy

  • 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

    Procedure: Adrenalectomy

Interventions

  • ProcedureAdrenalectomy

    Scheduled adrenal surgery

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What researchers measure

Primary outcomes

  1. 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 (\<P75), no readmissions, and no mortality in the first 30 days

    Time frame: January 2010 to December 2022

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Study locations

1 site
  • Juan Jesús Rubio García
    Alicante, 03010, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, 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
NCT05888753
Lead sponsor
Hospital General Universitario de Alicante
Responsible party
Candido Fernando Alcazar-Lopez (Principal Investigator, Physician, Hospital General Universitario de Alicante) — Principal investigator
First posted
Jun 5, 2023
Start date
Sep 1, 2022
Primary completion
Dec 31, 2022
Completion
Apr 1, 2023
Last update
Jun 22, 2023

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 completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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