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Not yet recruitingNCT06731296TraViIIUpdated Nov 21, 2025

General Surgery Patients at the Intensive Care Unit

An observational study in Critical Illness and Postoperative Complications, sponsored by Hospital Departamental de Villavicencio. Not yet recruiting at 2 sites in Colombia. Open to participants aged 15 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Hospital Departamental de Villavicencio · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
1,000
Ages
15 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored to minimize surgical or non-surgical complications. It is necessary to identify factors associated with adverse outcomes. 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 to establish predictive models of adverse outcomes in the admission to the intensive care unit to implement early preventive interventions.

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.

02

Conditions studied

  • Critical Illness
  • Postoperative Complications

Keywords

  • Acute Care Surgery
  • Operative Surgical Procedures
  • Perioperative Care
  • Critical Care
  • Intensive Care Units
  • In-hospital Mortality
  • Colombia
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Hospital Departamental de Villavicencio is the lead sponsor of 16 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients admitted from another hospital.
  • Surgical procedures performed in another hospital.
  • Surgical patients referred to another hospital.
05

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPresence of a risk factor

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

06

What researchers measure

Primary outcomes

  1. ICU mortality

    ICU discharges due to patient death in the ICU.

    Time frame: 30 days

Secondary outcomes

  1. ICU length of stay

    ICU length of stay

    Time frame: 30 days

07

Study locations

2 sites
  • Clinica Primavera
    Villavicencio, Meta Department 50001, Colombia
  • Hospital Departamental de Villavicencio
    Villavicencio, Meta Department 50001, Colombia
08

References and documents

Publications

  • 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. PubMed 34014060 ↗
  • 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. PubMed 34587207 ↗
  • 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. PubMed 34252060 ↗
  • 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. PubMed 37427992 ↗
  • 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. PubMed 37071812 ↗
  • 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. PubMed 36613197 ↗
  • 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. PubMed 36596587 ↗
  • 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. PubMed 37550589 ↗
  • 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. PubMed 35895502 ↗
  • 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. PubMed 38789003 ↗

Individual participant data

Plan to share: No — The data contains sensitive information of patients.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06731296
Lead sponsor
Hospital Departamental de Villavicencio
Responsible party
Norton Perez-Gutierrez, MD (ICU chief of staff, Hospital Departamental de Villavicencio) — Principal investigator
First posted
Dec 12, 2024
Start date
Aug 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Nov 21, 2025

Study contacts

Norton Perez, MD
Contact
norton.perez@hotmail.com
3112517471
Norton Perez, MD
principal investigator · Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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