Colombian Surgical Outcomes Study - COLSOS

NCT05147623 | Unknown DMC

• 1 other identifier: 2021-PRO-CAR-1538
• Study Type: observational
• Target: 1,353
• Locations: 1 country
• Sites: 2

Brief Summary

An observational, analytical, multicentre prospective cohort study will be conducted throughout Colombia. A sample size of 1353 patients is needed to achieve significance in our primary objective; however, convenience sampling is considered, as we aim to include all the institutions and patients possible. The data collection will be carried out prospectively for one week, and all patients will have a follow-up of a maximum of 30 days in-hospital. The primary outcome will be to determine the in-hospital mortality. We aim to contribute with accurate information on in-hospital postoperative mortality in Colombia. Thus, by following precisely the instructions created by The Lancet Commission on Global Surgery. The data obtained will help formulate public policies in the surgical field adjusted to the Colombian population, improving the quality of the surgical divisions in the different Colombian institutions, positively affecting the attention and development of the Colombian healthcare system.

Conditions

Surgery; Postoperative Complications; Hospital Mortality

Keywords

Hospital mortality; Postoperative complications; Surgery; Public Health

Outcome Measures

Primary Outcomes (1)

• In-hospital postoperative mortality

  In-hospital postoperative mortality of patients who have had surgical procedures in Colombian institutions.

  30 days

Secondary Outcomes (1)

• Postoperative complications

  30 days

Study Arms (1)

Principal cohort

All patients recruited in one week who underwent to any surgical procedure that meet inclusion criteria of the study.

Procedure: Any surgery/procedure

Interventions

Any surgery/procedure PROCEDURE

Any surgery/procedure in all adult patients that were performed in an operating room

Principal cohort

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

All patients of legal age who underwent to surgical procedures by the participating institutions in the data collection period will be included.

You may qualify if:

• Patients over 18 years of age.
• Ones who underwent to a surgical intervention in the collection period, by the participating institutions.
• Both public and private institutions will be included.
• Patients with and without COVID-19 infection will be included.

You may not qualify if:

• Patients who do not have the necessary clinical records to complete the information during data collection.
• The following shall be excluded:
• Procedures that were performed outside of operating rooms.
• Radiological procedures.
• Endoscopic procedures.

Sponsors & Collaborators

• Fundación Cardioinfantil Instituto de Cardiología: lead
• Universidad del Rosario: collaborator

Study Sites (2)

Fundación Cardioinfantil Instituto de Cardiología

Bogotá, Cundinamarca, 101101, Colombia

Location

Clínica Avidanti

Ibagué, Tolima Department, Colombia

Location

Related Publications (1)

• Perez-Rivera CJ, Lozano-Suarez N, Velandia-Sanchez A, Polania-Sandoval CA, Garcia-Mendez JP, Idarraga-Ayala SV, Corso-Ramirez JM, Conde-Monroy D, Cruz-Reyes DL, Duran-Torres CF, Barrera-Carvajal JG, Rojas-Serrano LF, Garcia-Zambrano LA, Agudelo-Mendoza SV, Briceno-Ayala L, Cabrera-Rivera PA; ColombianSurg Collaborative. Perioperative mortality in Colombia: perspectives of the fourth indicator in The Lancet Commission on Global Surgery - Colombian Surgical Outcomes Study (ColSOS) - a protocol for a multicentre prospective cohort study. BMJ Open. 2022 Nov 30;12(11):e063182. doi: 10.1136/bmjopen-2022-063182.

  PMID: 36450427 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paulo A. Cabrera, MD, MSc

  Fundación Cardioinfantil Instituto de Cardiología

  PRINCIPAL INVESTIGATOR

• Carlos J. Perez, MD, MSc

  Fundación Cardioinfantil Instituto de Cardiología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: November 16, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 22, 2023
• Last Updated: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)