Textbook Outcome in Adrenal Neoplasms

NCT ID: NCT05888753

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Outcome Assessment Adrenal Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Adrenalectomy

Intervention Type PROCEDURE

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

Adrenalectomy

Intervention Type PROCEDURE

Scheduled adrenal surgery

Interventions

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Adrenalectomy

Scheduled adrenal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario de Alicante

OTHER

Sponsor Role lead

Responsible Party

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Candido Fernando Alcazar-Lopez

Principal Investigator, Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Juan Jesús Rubio García

Alicante, , Spain

Site Status

Countries

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Spain

References

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Rubio-Garcia JJ, Gil Navarro R, Franco Campello M, Costa Navarro R, Gomis Martin A, Villodre Tudela C, Zaragoza Zaragoza C, Carrion Tomas A, Ramia-Angel JM. A novel study, textbook outcome in adrenalectomy: retrospective observational study in an endocrine surgical unit. Updates Surg. 2024 Apr;76(2):565-571. doi: 10.1007/s13304-024-01756-z. Epub 2024 Feb 5.

Reference Type DERIVED
PMID: 38316738 (View on PubMed)

Other Identifiers

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05/2023

Identifier Type: -

Identifier Source: org_study_id

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