Preventing colon anastomotic leaks by stenting the superior mesenteric artery

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

The study offers preoperative percutaneous transluminal angioplasty with covered stent placement of the superior mesenteric artery for patients who have an asymptomatic >50% origin stenosis and are scheduled for elective colon resection with a primary anastomosis. Enrolled patients receive the endovascular procedure and mono antiplatelet therapy, then undergo the planned colectomy; outcomes include rate and severity of anastomotic leakage, delayed leaks, mesenteric artery calcification score, surgical complications, readmissions, and quality of life. It is a multicenter effort at hospitals in the Netherlands and enrolls adults over 40 without symptoms of chronic or acute mesenteric ischemia. The trial aims to determine whether preventive SMA revascularization improves perfusion-related surgical outcomes compared with expected baseline rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>40 years.
* Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end).
* Presence of an asymptomatic \>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA)

Exclusion Criteria:

* All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial abdominal pain, fear of eating, altered eating patterns, weight loss, diarrhoea, nausea, or exercise-induced abdominal pain).
* Presence of a \>50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular thrombus or external compression by the median accurate ligament).
* Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b/T4c colon tumour resection, or a second colon anastomosis or a diverting stoma
* History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries
* Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft.
* Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance.
* Pregnancy

Where it's running

• 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
• Ziekenhuisgroep Twente
  Almelo, Overijsel, Netherlands Recruiting

Study contacts

• Principal investigator: Bob H. Geelkerken, Prof. dr. — Medisch Spectrum Twente
• Study coordinator: Koen J. Vree Egberts, MD, PhD Candicate
• Email: koen.vreeegberts@mst.nl
• Phone: +31 6 15247413

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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.