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Completed

NCT Number: NCT05888753

Textbook Outcome in Adrenal Neoplasms

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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Key information

Conditions

Outcome Assessment Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenal Neoplasm Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Juan Jesús Rubio García

Alicante, 03010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adrenalectomy

Procedure

Scheduled adrenal surgery

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario de Alicante

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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