NCT05888753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

May 24, 2023

Last Update Submit

June 19, 2023

Conditions

Outcome AssessmentAdrenal Neoplasm

Outcome Measures

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

    January 2010 to December 2022

Study Arms (2)

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

AdrenalectomyPROCEDURE

Scheduled adrenal surgery

No Textbook outcomeYes Textbook Outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients undergoing elective adrenal resection were eligible for the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Jesús Rubio García

Alicante, 03010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 38316738DERIVED

MeSH Terms

Conditions

Adrenal Gland Neoplasms

Interventions

Adrenalectomy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physician

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 5, 2023

Study Start

September 1, 2022

Primary Completion

December 31, 2022

Study Completion

April 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)