PI: prof. dr. R.H. Geelkerken Medisch Spectrum Twente, Enschede
SI: K.J. Vree Egberts, Phd kandidaat Universiteit Twente, Medisch Spectrum Twente, Enschede & Franciscus, Rotterdam
Introduction
Anastomotic leakage (AL) is a severe complication of colorectal 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 colorectal cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study (Harmankaya et al., 2024) identified a >50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (95% CI: 2.78–12.60, p < .001).
Objectives
The ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a >50% stenosed SMA origin reduces AL risk, improves quality of life, and lowers healthcare costs. Additionally, in hospitals with suitable equipment and experience, the study will explore the use of quantitative fluorescence angiography (Q-FA) with indocyanine green (ICG) fluorescence to measure anastomotic microcirculation and its association with AL risk.
Study Design
Nation-wide randomized controlled trial (RCT) in which patients are randomized 1:1 to undergo either preventive endovascular SMA stenting or no stenting prior to colorectal resection.
Study Population
Patients in the Netherlands with a >50% SMA stenosis scheduled for elective colorectal resection with a primary anastomosis for malignant or benign pathology.
Endpoints
The primary endpoint is AL prevalence within 30 days post-surgery. Secondary endpoints include Q-FA measurements, AL classification/severity, calcification scores of aortic and mesenteric vessels, peri-operative hemodynamics, operative duration, stenting complications, hospital stay, patient-reported outcomes (PROMs), and cost-effectiveness (CEA/BIA).
Contact: Koen.VreeEgberts@mst.nl