Creation, Implementation and Validation of Intra- and Postoperative Risk Prediction Models

NCT06411496 | Completed

• 1 other identifier: PI2023/029
• Study Type: observational
• Target: 112,745
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to create and validate surgical risk prediction models for the prediction of complications in patients pending surgery during the operation, in the immediate postoperative period and up to one month after discharge. At present there is no risk assessment system in place, except for the ASA scale which is mainly based on the subjective impression of the facultative, who assesses it in the universal preoperative consultations that we have planned in the system. In this project we intend to provide robust models, based on the analysis of data from patients in 4/5 Basque hospitals, i.e. generated in our population.

Conditions

Postoperative Complications; Risk Factors

Outcome Measures

Primary Outcomes (1)

• Death intraoperatively and up to one month after surgery

  yes/not

  One-month

Secondary Outcomes (3)

• Intensive care unit admission

  One month

• intra-operative complications

  Complications during the intervention

• readmission

  One month

Study Arms (1)

Scheduled or urgent surgery

This is a retrospective cohort study recruiting surgical patients at Galdakao-Usansolo Hospital between 2019 and 2022. We used anonymized patient level data from patients in waiting list to be intervened in four public hospitals in Basque Country.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients at Galdakao-Usansolo Hospital between 2019 and 2022. We used anonymized patient level data from patients in waiting list to be intervened in four public hospitals in Basque Country. Participating hospitals serve a population of approximately 1.2 million and provide tertiary referral services to the surrounding region.

You may qualify if:

• Patients over 18 years of age pending scheduled or urgent surgery in non-cardiac surgery.

You may not qualify if:

• Surgery performed under local anaesthesia
• Paediatric Surgery
• Obstetric Patient
• Cardiac Surgery

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Hospital Galdakao Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francisco Mendoza, MD

  Galdakao-Usansolo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colaborator

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

ES (1)