TEXTBOOK OUTCOME IN ADRENAL NEOPLASMS

• Sponsor: Hospital General Universitario de Alicante (Other)
• Overall Status: Completed
• CT.gov ID: NCT05888753
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 15.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Outcome Assessment; Adrenal Neoplasm	Procedure: Adrenalectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 105 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A NOVEL STUDY, TEXTBOOK OUTCOME IN ADRENAL NEOPLASMS: OBSERVATIONAL STUDY IN AN ENDOCRINE SURGICAL UNIT.
• Actual Study Start Date: Sep 1, 2022
• Actual Primary Completion Date: Dec 31, 2022
• Actual Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	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	Procedure: Adrenalectomy; 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	Procedure: Adrenalectomy; Scheduled adrenal surgery

Outcome Measures

Primary Outcome Measures

1. Textbook Outcome [January 2010 to December 2022]

   analyse the achievement of Textbook Outcome in a series of patients undergoing scheduled adrenal resection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juan Jesús Rubio García	Alicante		Spain	03010

Sponsors and Collaborators

• Hospital General Universitario de Alicante

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Candido Fernando Alcazar-Lopez, Principal Investigator, Physician, Hospital General Universitario de Alicante
• ClinicalTrials.gov Identifier: NCT05888753
• Other Study ID Numbers: 05/2023
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Adrenal Gland Neoplasms

Study Results

No Results Posted as of Jun 5, 2023