Condition: Mesenteric Vascular Disease · Colorectal Surgery · Preventive Intervention · Sponsor: Medisch Spectrum Twente
Rationale: Anastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization. Among colon cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study identified a \>50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (OR: 5.9, 95% CI: 2.7-12.6, p \< .001). Primary objective: The ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \>50% stenosed SMA origin reduces the risk of AL following colon surgery. Secondary objectives: Classification of severity of AL, incidence of delayed AL (\>90 days), Mesenteric Artery Calcification Score (MACS), surgical complications, hospital (re)admissions, Quality of life (including health related quality of life), healthcare and societal costs, cost-effectiveness (expressed as incremental costs per quality-adjusted life year gained), and budget impact. Additionally, the added value of quantitative fluorescence angiography (qFA) in predicting AL during surgery, in hospitals with suitable equipment and experience, will be explored. This will enhance surgeons' capabilities in preventing AL. Study design: Nationwide multicentre randomized controlled trail with a 1:1 fashion Study population: Pa…
This description comes directly from the study's public registry record.
Koen J. Vree Egberts, MD, PhD Candicate · +31 6 15247413 · koen.vreeegberts@mst.nl
Research Coordinator Surgery · + 053 487 34 42 · ALPrES2MA@mst.nl
Always discuss trial participation with your own doctor first.
| Treant | Emmen, Drenthe, Netherlands | Not Yet Recruiting |
| Meander | Amersfoort, Gelderland, Netherlands | Not Yet Recruiting |
| Gelre ziekenhuis | Apeldoorn, Gelderland, Netherlands | Recruiting |
| Zuyderland | Heerlen, Limburg, Netherlands | Recruiting |
| Maastricht Universitair Medisch Centrum (MUMC+) | Maastricht, Limburg, Netherlands | Recruiting |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch, North Brabant, Netherlands | Recruiting |
| Noordwest Ziekenhuisgroep | Alkmaar, North Holland, Netherlands | Recruiting |
| Spaarne Gasthuis | Haarlem, North Holland, Netherlands | Not Yet Recruiting |
| Ziekenhuisgroep Twente | Almelo, Overijsel, Netherlands | Recruiting |
| Medisch Spectrum Twente | Enschede, Overijsel, Netherlands | Recruiting |
| Nij Smellinghe | Drachten, Provincie Friesland, Netherlands | Recruiting |
| Martini Ziekenhuis | Groningen, Provincie Groningen, Netherlands | Not Yet Recruiting |
+ 6 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07486570