Study on complications and long-term outcomes after high-risk surgeries
Perioperative Longitudinal Study of Complications and Long-term Outcomes
This study is trying to see how well we can predict and identify complications in patients having high-risk surgeries by monitoring them closely after their operations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05331118 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve preoperative risk assessment and early diagnosis of complications in patients undergoing elective intermediate to high-risk non-cardiac surgeries. Participants will be monitored daily for the first week post-surgery by dedicated observers who will assess clinical events and perform non-invasive physiological measurements. Additionally, blood and microbiome samples will be collected at various time points to establish a comprehensive biorepository for future research. The primary outcomes focus on the occurrence of infections, major cardiac events, and pulmonary complications.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing elective high-risk gastrointestinal or vascular procedures, or intermediate-risk surgeries with specific criteria.
Not a fit: Patients under 18 years, those requiring emergency surgery, or individuals with severe anemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative recovery and improve long-term outcomes for patients undergoing high-risk surgeries.
How similar studies have performed: While similar observational studies have been conducted, this specific approach to establishing a biorepository for perioperative complications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Undergoing an elective, high-risk gastro-intestinal or vascular procedure, or intermediate risk procedure (including gynaecological, orthopaedic and head and neck surgery) if the procedure includes a laparotomy and/or is associated with a scheduled hospital length of stay ≥ 5 days. Exclusion Criteria: * \< 18 years of age * Emergency surgery * Severe anaemia (Hb \< 4.5 mmol/L) * Unable to provide informed consent
Where this trial is running
Utrecht
- University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nikki de Mul, MSc
- Email: PLUTO@umcutrecht.nl
- Phone: +31887561124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.