General Surgery Patients at the Intensive Care Unit

NCT06731296 | Not Yet Recruiting

• 1 other identifier: GRIVI_2024_01_QX_UCI
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU. Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value \<0.05 will be selected as statistical significance. Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality. Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.

Conditions

Critical Illness; Postoperative Complications

Keywords

Acute Care Surgery; Operative Surgical Procedures; Perioperative Care; Critical Care; Intensive Care Units; In-hospital Mortality; Colombia

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  ICU discharges due to patient death in the ICU.

  30 days

Secondary Outcomes (1)

• ICU length of stay

  30 days

Study Arms (2)

Abdominal surgery

Patients admitted to the ICU after an abdominal surgery.

Other: Presence of a risk factor

Older adults

Older adults (65+) surgical patients admitted to the ICU.

Other: Presence of a risk factor

Interventions

Presence of a risk factor OTHER

Demographic, severity, type of surgery, diagnosis, diagnostic system, type of admission.

Abdominal surgery; Older adults

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General surgery patients admitted to the ICU, especially for postoperative care.

You may qualify if:

• Patients with a surgical diagnosis admitted to the ICU.
• Patients in the operative period admitted to the ICU.

You may not qualify if:

• Patients admitted from another hospital.
• Surgical procedures performed in another hospital.
• Surgical patients referred to another hospital.

Sponsors & Collaborators

• Hospital Departamental de Villavicencio: lead

Study Sites (2)

Clinica Primavera

Villavicencio, Meta Department, 50001, Colombia

Location

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (10)

• Dovzhanskiy DI, Schwab S, Bischoff MS, Brenner T, Weigand MA, Hinz U, Bockler D. Extended intensive care correlates with worsening of surgical outcome after elective abdominal aortic reconstruction. J Cardiovasc Surg (Torino). 2021 Dec;62(6):591-599. doi: 10.23736/S0021-9509.21.11842-7. Epub 2021 May 20.

  PMID: 34014060 RESULT

• Menzenbach J, Layer YC, Layer YL, Mayr A, Coburn M, Wittmann M, Hilbert T. The level of postoperative care influences mortality prediction by the POSPOM score: A retrospective cohort analysis. PLoS One. 2021 Sep 29;16(9):e0257829. doi: 10.1371/journal.pone.0257829. eCollection 2021.

  PMID: 34587207 RESULT

• Hynes AM, Lambe LD, Scantling DR, Bormann BC, Atkins JH, Rassekh CH, Seamon MJ, Martin ND. A surgical needs assessment for airway rapid responses: A retrospective observational study. J Trauma Acute Care Surg. 2022 Jan 1;92(1):126-134. doi: 10.1097/TA.0000000000003348.

  PMID: 34252060 RESULT

• Peters F, Hohenstein S, Bollmann A, Kuhlen R, Ritz JP. The Postoperative Utilization of Intensive Care Beds After Visceral Surgery Procedures. Dtsch Arztebl Int. 2023 Sep 22;120(38):633-638. doi: 10.3238/arztebl.m2023.0158.

  PMID: 37427992 RESULT

• Timan TJ, Karlsson O, Sernert N, Prytz M. Standardized perioperative management in acute abdominal surgery: Swedish SMASH controlled study. Br J Surg. 2023 May 16;110(6):710-716. doi: 10.1093/bjs/znad081.

  PMID: 37071812 RESULT

• Chinawong C, Utriyaprasit K, Sindhu S, Viwatwongkasem C, Suksompong S. Factors Influencing Pre-Cardiopulmonary Arrest Signs among Post-General Surgery Patients in Critical Care Service System. Int J Environ Res Public Health. 2023 Jan 3;20(1):876. doi: 10.3390/ijerph20010876.

  PMID: 36613197 RESULT

• Meschino MT, Vogt KN, Allen L, Saddik M, Nenshi R, Van Heest R, Saleh F, Widder S, Minor S, Joos E, Parry NG, Murphy PB, Ball CG, Hameed M, Engels PT; CANUCS (Canadian Collaborative on Urgent Care Surgery). Operating room use for emergency general surgery cases: analysis of the Patterns of Complex Emergency General Surgery in Canada study. Can J Surg. 2023 Jan 3;66(1):E13-E20. doi: 10.1503/cjs.008120. Print 2023 Jan-Feb.

  PMID: 36596587 RESULT

• Suarez-de-la-Rica A, Ripolles-Melchor J, Aldecoa C, Abad-Motos A, Ferrando C, Abad-Gurumeta A, Diaz-Almiron M, Gil-Lapetra C, Garcia-Miguel FJ, Pedregosa-Sanz A, Esteve-Perez N, Rodriguez-Jimenez R, Gimeno Fernandez P, Maseda E; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (RedGERM-SPARN). Postoperative Critical Care Admission Was Not Associated with Improved Postoperative Outcomes in Elective Colorectal Surgery: Secondary Analysis Of POWER Trial. J Gastrointest Surg. 2023 Oct;27(10):2187-2198. doi: 10.1007/s11605-023-05780-z. Epub 2023 Aug 7.

  PMID: 37550589 RESULT

• Yohann A, Kayange L, Purcell L, Gallaher J, Charles A. Acute care surgery in a Malawian district hospital: Epidemiology, outcomes, and assessment of operative capacity. Trop Doct. 2023 Jan;53(1):73-80. doi: 10.1177/00494755221102226. Epub 2022 Jul 27.

  PMID: 35895502 RESULT

• Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Neto PCDS, Castro SMJ, Stefani LC. Postoperative intensive care allocation and mortality in high-risk surgical patients: evidence from a low- and middle-income country cohort. Braz J Anesthesiol. 2024 Jul-Aug;74(4):844517. doi: 10.1016/j.bjane.2024.844517. Epub 2024 May 23.

  PMID: 38789003 RESULT

MeSH Terms

Conditions

Critical Illness; Postoperative Complications

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Norton Perez, MD

  Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norton Perez, MD

CONTACT

3112517471; norton.perez@hotmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU chief of staff

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)