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Stent before surgery slashes deadly leak risk in colon patients

NCT ID NCT07486570

Prevention Sponsor: Medisch Spectrum Twente Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tests whether placing a small mesh tube (stent) in a narrowed artery that supplies blood to the gut, done before planned colon surgery, can lower the risk of a serious complication called anastomotic leakage (a leak where the colon is reconnected). About 360 adults aged 40 and older with a significant narrowing in that artery will be randomly assigned to receive either the stent plus standard care or standard care alone. The goal is to see if the stent helps prevent leaks and improves recovery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak mesenteric vascular occlusion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal surgery Mesenteric vascular disease Preventive intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albert Schweitzer ziekenhuis

    NOT_YET_RECRUITING

    Dordrecht, Zuid, Netherlands

  • Diakonessenhuis

    NOT_YET_RECRUITING

    Utrecht, Utrecht, Netherlands

  • Franciscus

    RECRUITING

    Rotterdam, South Holland, 3004 BA, Netherlands

  • Gelre ziekenhuis

    RECRUITING

    Apeldoorn, Gelderland, Netherlands

  • Haaglanden Medisch Centrum

    NOT_YET_RECRUITING

    The Hague, South Holland, Netherlands

  • Jeroen Bosch Ziekenhuis

    RECRUITING

    's-Hertogenbosch, North Brabant, Netherlands

  • Maasstad ziekenhuis

    RECRUITING

    Rotterdam, South Holland, Netherlands

  • Maastricht Universitair Medisch Centrum (MUMC+)

    RECRUITING

    Maastricht, Limburg, Netherlands

  • Martini Ziekenhuis

    NOT_YET_RECRUITING

    Groningen, Provincie Groningen, Netherlands

  • Meander

    NOT_YET_RECRUITING

    Amersfoort, Gelderland, Netherlands

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, Overijsel, 7512KZ, Netherlands

  • Nij Smellinghe

    RECRUITING

    Drachten, Provincie Friesland, Netherlands

  • Noordwest Ziekenhuisgroep

    RECRUITING

    Alkmaar, North Holland, Netherlands

  • Spaarne Gasthuis

    NOT_YET_RECRUITING

    Haarlem, North Holland, Netherlands

  • Treant

    NOT_YET_RECRUITING

    Emmen, Drenthe, Netherlands

  • Universitair Medisch Centrum Groningen

    NOT_YET_RECRUITING

    Groningen, Provincie Groningen, Netherlands

  • Ziekenhuisgroep Twente

    RECRUITING

    Almelo, Overijsel, 7609 PP, Netherlands

    Contact Email: •••••@•••••

  • Zuyderland

    RECRUITING

    Heerlen, Limburg, Netherlands

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