Study on complications and long-term outcomes after high-risk surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Medical Center Utrecht
  Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: Nikki de Mul, MSc
• Email: PLUTO@umcutrecht.nl
• Phone: +31887561124

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.