Actively Recruiting

Age: 18Years +
All Genders
ID05331118

Perioperative Longitudinal Study of Complications and Long-term Outcomes

Led by UMC Utrecht · Updated on 2023-11-29

9000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients undergoing elective intermediate to high-risk non-cardiac surgery to better understand and predict complications that can affect recovery and long-term health. This observational study aims to create a large biorepository by collecting detailed clinical data, blood samples, and microbiome specimens throughout the perioperative period. The goal is to improve risk assessment, detect complications early, and explore the causes and effects of these events on patient outcomes. Participants include adults having elective high-risk gastrointestinal or vascular surgery, or intermediate risk surgeries such as gynecological, orthopedic, or head and neck procedures that involve laparotomy or a hospital stay of five days or more. During the first seven days after surgery, or longer if needed, trained observers visit patients daily at their bedside to record clinical events and perform non-invasive tests like handheld spirometry and single-channel EEG. Blood and microbiome samples are collected at specific times to support biomarker research. Throughout the study, participants will undergo continuous monitoring for infections, heart events, lung complications, kidney injury, and delirium during their hospital stay. Additional evaluations include pain tracking, complication severity, and assessments of mental health, cognitive function, and survival up to one year after surgery. The data gathered will help develop prediction models and improve understanding of postoperative risks and recovery. The overall participation duration varies depending on individual recovery and follow-up assessments.

CONDITIONS

Brief Title

Perioperative Longitudinal Study of Complications and Long-term Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing an elective, high-risk gastrointestinal or vascular procedure
  • Undergoing an intermediate risk procedure (including gynecological, orthopedic, and head and neck surgery) that includes laparotomy or requires a hospital stay of 5 days or more
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Emergency surgery
  • Severe anemia (hemoglobin less than 4.5 mmol/L)
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Duration of hospital admission

Participants are observed for complications and outcomes during their hospital admission.

Visits during hospital stay as per routine care

Long-term Monitoring

Duration - Up to 1 year after surgery

Participants are followed up for long-term outcomes including psychopathology, cognitive dysfunction, and mortality.

1 visit at 1-year follow-up

Trial Site Locations

Total: 1 location

1

University Medical Center Utrecht

Utrecht, Netherlands, 3584CX

Actively Recruiting

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Research Team

N

Nikki de Mul, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications.

Nikki de Mul, Diede Verlaan, Jelle P Ruurda...

https://pubmed.ncbi.nlm.nih.gov/37076142