Ireland
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Active, not recruiting Not applicable

Effects of Preoperative Multidisciplinary Team Meetings for High-risk, Adult, Noncardiac Surgical Patients

NCT05703230 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2022-11-01
Last updated
2026-02-25

Condition(s) studied

Interdisciplinary CommunicationPostoperative ComplicationsNoncardiac SurgerySurgical Procedures, OperativePreoperative CarePatient Care TeamCost-Benefit AnalysisComorbidities and Coexisting Conditions

Investigational drug(s) / intervention(s)

Structured preoperative multidisciplinary team meeting

Structured preoperative multidisciplinary team meeting: The intervention to be investigated is the introduction of a preoperative structured multidisciplinary team (sMDT) meeting for high risk noncardiac surgical patients, which is attended by at least the treating surgical specialist, an anesthesiologist and another medical consultant with expertise relevant for the patients comorbidities and preferences. In the preoperative sMDT meeting, at least the following questions will be discussed as recommended by the Dutch Perioperative Guideline: * Is the proposed surgical intervention appropriate care for the patient? * Is the risk/benefit ratio of the proposed surgical intervention acceptable for the patient? * Should the patient's condition be optimized before undergoing the proposed surgical intervention?

Study summary

The current multicenter stepped wedge randomized cluster trial study aims to assess whether implementation of preoperative multidisciplinary team (MDT) discussions is (cost)effective for high risk noncardiac surgical patients.

The main questions to answer are:

* Primary question: Does implementation of preoperative multidisciplinary team discussions for high risk noncardiac surgical patients diminish serious adverse events as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment?
* Secondary questions: Does implementation of preoperative multidisciplinary team discussion for high risk noncardiac surgical patients improve disability, survival, functional outcome, quality of life and cost-effectiveness as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment?

Participants will be asked to answer questionnaires at baseline, 3, 6,9 and 12 months postoperatively or post MDT discussion.

Patients for whom no structured preoperative multidisciplinary discussion is installed yet (care as usual) will be compared with patients for whom a structured preoperative multidisciplinary discussion is performed (intervention).

The study will be performed in hospitals that have no established preoperative MDT meeting at the start of the study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years of age or older; and * American Society of Anesthesiology Physical Status (ASA-PS) score is 3 or more; and * Clinical Frailty Scale score is 4 or more; and * Patient is planned for elective or semi-elective noncardiac surgery; and * As stated by the Dutch perioperative guideline: * Doubt by the surgeon or anesthesiologist (or other discipline) regarding harm-benefit ratio of the surgical procedure; or * Doubt if the correct measures were taken to limit the perioperative risk as much as possible; or * Doubt if the patient agrees with the surgery or the anesthesiologic treatment and expected risks. Exclusion Criteria: * no informed consent * unable to communicate with patient (either directly or through third party) * emergency surgery * Proposed surgical intervention for which a structured preoperative multidisciplinary team meeting, similar to the current study intervention, already exists in this respective hospital at the start of the study

Primary outcome measure(s)

  • Serious Adverse Events (SAEs) — 6 months
    Serious adverse events (SAEs), defined as: 1. Grade 3 or more on the Clavien Dindo classification following surgical intervention, or 2. non-operative SAEs will be graded accordingly i.e., events necessitating hospital admission, surgical intervention, single or multi-organ failure, or death.

Trial sites (14)

FacilityCityRegionStatus
Stichting Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
Stichting Meander Medisch Centrum Amersfoort Netherlands
Stichting OLVG Amsterdam Netherlands
Gelre Ziekenhuis Apeldoorn Netherlands
Stichting Albert Schweitzer Ziekenhuis Dordrecht Netherlands
Groene Hart Ziekenhuis Gouda Netherlands
Universitair Medisch Centrum Groningen Groningen Netherlands
Zuyderland Medisch Centrum Heerlen Netherlands
Maastricht Universitair Medisch Centrum Maastricht Netherlands
Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina Nijmegen Netherlands
Stichting Bravis Ziekenhuis Roosendaal Netherlands
Stichting Protestants Christelijk Ziekenhuis Ikazia Rotterdam Netherlands
Maxima Medisch Centrum Veldhoven Netherlands
Zaans Medisch Centrum Zaandam Netherlands
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05703230 on ClinicalTrials.gov ↗ ← All trials in the Netherlands