Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery (ALPrES²MA)

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:

Patients, 40 years and over, in the participating hospitals in the Netherlands with a >50% SMA origin stenosis scheduled for elective colorectal resection with a primary anastomosis for malignant or benign colorectal pathology.

Intervention:

Intervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting of the SMA, within preferably two weeks prior to the colon resection. Control group will not undergo PTA and endovascular stenting of the >50% SMA stenosis prior to the colon resection. Both groups will be treated with a mono antiplatelet therapy, i.e., carbasalate calcium (Ascal ®), for stent patency and atherosclerotic risk reduction. Intervention group has an indication for lifelong mono antiplatelet therapy and control group for at least 12 months

Main study parameters/endpoints:

The primary endpoint is the incidence of a clinically relevant AL within 90 days post-surgery. Secondary endpoints include AL classification/severity, calcification scores of aortic and mesenteric vessels, stenting complications, stent patency, intra-operative qFA measurements, operative duration, all causes of post-operative complications within 90 days, all reinterventions; surgical (including endovascular) and non-surgical within 90 days, duration of primary postoperative hospital stay and readmission within 12 months, 12 month mortality, patient-reported outcomes on month 0-3-6-12, cost-effectiveness budget impact analysis and stent patency. The total follow-up duration will be a total of 12 months.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Surgery; Preventive Intervention; Mesenteric Vascular Disease
• Intervention / Treatment: Procedure: Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery; Procedure: Colon surgery; Drug: Mono antiplatelet therapy with Ascal 80mg daily

Detailed Description

Background and Rationale:

Anastomotic leakage (AL) is one of the most severe complications following colon surgery. The pathogenesis of AL is multifactorial and includes patient-related, surgical, and perfusion-related factors. However, reliable preoperative identification of patients at high risk for AL remains challenging. Existing prediction models are heterogeneous and rarely incorporate mesenteric vascular disease as a risk factor.

A retrospective multicenter case-control study demonstrated that an asymptomatic >50% atherosclerotic stenosis at the origin of the superior mesenteric artery (SMA) is associated with a six-fold increased risk of AL following elective colon resection. Despite this association, current surgical and vascular guidelines do not address preventive treatment of asymptomatic SMA stenosis in patients undergoing colorectal surgery, and preventive endovascular revascularization is not standard practice.

Endovascular revascularization of the SMA using percutaneous transluminal angioplasty (PTA) and covered stent placement is a minimally invasive, low-risk procedure widely used in the treatment of chronic and acute mesenteric ischemia. The procedure has a low incidence of serious adverse events and is supported by international guidelines. Whether preventive SMA stenting can improve colon perfusion and reduce the risk of AL in asymptomatic patients undergoing colon surgery has not been prospectively evaluated.

The ALPrES²MA study (Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery) is a multicenter randomized controlled trial designed to address this evidence gap.

Study Objectives The primary objective of this study is to determine whether preventive endovascular covered stenting of an asymptomatic 50% or more stenosis at the origin of the SMA reduces the incidence of clinically relevant anastomotic leakage within 90 days after elective colon resection with primary anastomosis.

Secondary objectives include comparison between intervention and control groups with respect to:

• Severity classification of AL (Grade A, B, or C)
• Incidence of delayed AL (>90 days, up to 12 months)
• Incidence of isolated, clinically non-significant AL
• Mesenteric Artery Calcification Score (MACS) on preoperative CT imaging
• Intraoperative microcirculatory perfusion assessed with quantitative fluorescence angiography (qFA), where available
• Postoperative complications classified by Clavien-Dindo
• Reinterventions (surgical and non-surgical)
• Hospital length of stay and readmissions
• All-cause mortality within 12 months
• Quality of life and health-related quality of life
• Healthcare consumption, productivity losses, cost-effectiveness, and budget impact

Secondary objectives specific to the intervention group include evaluation of stent-related adverse events, stent patency, access-site complications, and reinterventions related to SMA stenting.

Study Design

This is a multicenter, randomized controlled trial with a 1:1 allocation ratio. Eligible patients are randomized to either:

1. Preventive endovascular PTA with covered stent placement of the SMA prior to elective colon resection (intervention group), or
2. Elective colon resection without preventive SMA stenting (control group).

Randomization is stratified by participating center to ensure balanced distribution of center-specific factors, including the use of intraoperative fluorescence angiography. This is a non-blinded study.

Study Population The study population consists of patients aged 40 years or older who are scheduled for elective colon resection with primary anastomosis for malignant or benign colorectal disease and who have an asymptomatic 50% or more atherosclerotic stenosis at the origin of the SMA.

Key exclusion criteria include symptomatic mesenteric ischemia, significant celiac artery stenosis (50% or more), prior mesenteric revascularization, simultaneous major additional abdominal resections, creation of diverting stomas, contraindications to antiplatelet therapy, pregnancy, or known intolerance to study medications or devices.

Assessment of SMA Stenosis All patients undergo routine preoperative abdominal CT imaging as part of standard surgical planning. CT scans are centrally reviewed by an independent Corelab consisting of trained radiologists and vascular surgeons to assess the degree of SMA stenosis and vascular calcification. If image quality is insufficient or stenosis severity is uncertain, an additional CT angiography with slice thickness <1 mm is performed in accordance with international guidelines.

Interventions Patients randomized to the intervention group undergo preventive PTA and placement of a covered balloon-expandable stent (GORE® VIABAHN® Balloon Expandable Endoprosthesis) at the origin of the SMA, preferably within two weeks prior to colon surgery. The procedure is performed by experienced vascular specialists in designated regional centers using standard endovascular techniques.

Patients in both study groups receive mono antiplatelet therapy with carbasalate calcium (100 mg daily). In the intervention group, antiplatelet therapy is prescribed lifelong to support stent patency; in the control group, therapy is prescribed for at least 12 months for secondary prevention of atherosclerotic disease.

Elective colon resection is performed according to standard local and national guidelines at the patient's primary surgical center.

Intraoperative Fluorescence Angiography:

In participating centers where fluorescence angiography with indocyanine green (ICG) is part of standard care, intraoperative assessment of anastomotic perfusion is performed in both study groups. Quantitative fluorescence angiography (qFA) parameters, including time-to-peak and normalized peak slope, are analyzed centrally for exploratory evaluation of microperfusion and its association with AL.

Follow-up and Data Collection Patients are followed for a total of 12 months after colon surgery. The primary endpoint is assessed within the first 90 days. Secondary clinical outcomes, stent patency, mortality, and reinterventions are assessed throughout the 12-month follow-up.

Patient-reported outcomes are collected preoperatively and at multiple postoperative time points using validated questionnaires, including WHO-QoL-BREF, EQ-5D-5L, iMTA Medical Consumption Questionnaire, and iMTA Productivity Cost Questionnaire. Data are collected electronically, on paper, or via structured interviews without requiring additional hospital visits.

Outcome Measures The primary outcome is the incidence of clinically relevant anastomotic leakage (Grade B or C) within 90 days postoperatively. AL is defined according to established international criteria.

Secondary outcomes include AL severity, delayed AL, postoperative complications, hospital utilization, mortality, quality of life, health economic outcomes, and SMA stent patency.

Sample Size and Statistical Analysis:

Based on an expected reduction in AL incidence from 14% to 5%, a total sample size of 360 patients (180 per group) provides 80% power with a two-sided alpha of 0.05, accounting for a 10% dropout rate. An interim analysis is conducted for sample size re-estimation and futility assessment without formal hypothesis testing.

Primary analysis compares AL incidence between groups using chi-square or Fisher's exact tests and logistic regression. Secondary outcomes are analyzed using appropriate parametric or non-parametric methods, generalized estimating equations for repeated measures, and multivariable models to adjust for predefined confounders.

Health Economic Evaluation A cost-effectiveness analysis is performed from a societal perspective over a 12-month time horizon, expressing results as incremental cost per quality-adjusted life year gained. A budget impact analysis evaluates nationwide implementation scenarios over a five-year period from societal, governmental, and insurer perspectives.

Ethical Considerations All interventions used in this study are established, CE-marked devices or approved medicinal products used within their authorized indications. The potential benefits of reducing AL-related morbidity and mortality are weighed against the low procedural risks associated with preventive SMA stenting. Written informed consent is obtained from all participants prior to enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Koen J. Vree Egberts, MD, PhD Candicate; Phone Number: +31 6 15247413; Email: koen.vreeegberts@mst.nl
• Study Contact Backup: Name: Research Coordinator Surgery; Phone Number: + 053 487 34 42; Email: ALPrES2MA@mst.nl

Study Locations

• Netherlands
  • Gelderland
    • Apeldoorn, Gelderland, Netherlands
      • Recruiting
      • Gelre Ziekenhuis
      • Contact: Hessel Busscher
  • Limburg
    • Heerlen, Limburg, Netherlands
      • Recruiting
      • Zuyderland
      • Contact: Lee Bouwman
    • Maastricht, Limburg, Netherlands
      • Recruiting
      • Maastricht Universitair Medisch Centrum (MUMC+)
      • Contact: Tim Lubbers
  • North Brabant
    • 's-Hertogenbosch, North Brabant, Netherlands
      • Recruiting
      • Jeroen Bosch Ziekenhuis
      • Contact: Jan Willem Hinnen
  • North Holland
    • Alkmaar, North Holland, Netherlands
      • Recruiting
      • Noordwest Ziekenhuisgroep
      • Contact: Wouter Hogendoorn
  • Overijsel
    • Almelo, Overijsel, Netherlands, 7609 PP
      • Recruiting
      • Ziekenhuisgroep Twente
      • Contact: Ian Faneyte, dr. MD; Phone Number: +31 88 708 52 31; Email: researchverpleegkundigenheelkunde@zgt.nl
    • Enschede, Overijsel, Netherlands, 7512KZ
      • Recruiting
      • Medisch Spectrum Twente
      • Contact: Koen Vree Egberts; Phone Number: +31534873442; Email: ALPrES2MA@mst.nl
      • Principal Investigator: Anneriet Dassen, dr. MD
      • Principal Investigator: Bob Geelkerken, Prof. dr. MD
  • Provincie Friesland
    • Drachten, Provincie Friesland, Netherlands
      • Recruiting
      • Nij Smellinghe
      • Contact: Floris Poelmann
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3004 BA
      • Recruiting
      • Franciscus
      • Contact: Desiree van Noord, dr. MD; Phone Number: +31 10 - 461 7430; Email: D.Leemreis@franciscus.nl
    • Rotterdam, South Holland, Netherlands
      • Recruiting
      • Maasstad Ziekenhuis
      • Contact: Charles van Rossem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; The intervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting for a ≥50% atherosclerotic SMA stenosis prior to elective colon surgery with primary anastomosis. All patients will receive mono antiplatelet therapy with carbasalate calcium (Ascal®).	Procedure: Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery; The intervention group will recieve preventive percutaneous transluminal angiopasty and endovascular covered stenting of a ≥50% atherosclerotic SMA stenosis of the superior mesenteric artery. Stent graft that will be used is: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX stent graft), which is CE marked.; Other Names: Endovascular Stenting; Percutaneous Angioplasty; Procedure: Colon surgery; Both groups are scheduled for elective colon resection with primary anastomosis. The intervention will remain unchanged and will follow standard care protocols.; Other Names: Sigmoid resection; Ileocecal resection; Right hemicolectomy; Transverse colectomy; Left hemicolectomy; Drug: Mono antiplatelet therapy with Ascal 80mg daily; Both groups will receive mono antiplatelet therapy with Ascal daily 80mg for atherosclerotic risk reduction throughout the study period. In the intervention group, the therapy will also be administered to maintain stent patency.; Other Names: Carbasalate Calcium; Ascal ®
Other: Control Group; Control group will receive standard care for elective colon surgery with primary anastomosis, without preventive SMA PTA for a ≥50% atherosclerotic SMA stenosis. All patients will receive mono antiplatelet therapy with carbasalate calcium (Ascal®).	Procedure: Colon surgery; Both groups are scheduled for elective colon resection with primary anastomosis. The intervention will remain unchanged and will follow standard care protocols.; Other Names: Sigmoid resection; Ileocecal resection; Right hemicolectomy; Transverse colectomy; Left hemicolectomy; Drug: Mono antiplatelet therapy with Ascal 80mg daily; Both groups will receive mono antiplatelet therapy with Ascal daily 80mg for atherosclerotic risk reduction throughout the study period. In the intervention group, the therapy will also be administered to maintain stent patency.; Other Names: Carbasalate Calcium; Ascal ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anstomotic leakage (AL) after colon surgery with primary anastomosis	The primary objective of this study is to compare the intervention and control group on the incidence of AL following elective colon resection with primary anastomosis in patients with an asymptomatic >50% origin stenosis of the SMA.	Anastomotic Leakage within 90 days following colon resection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of severity of anastomotic leakage (AL)	Clinically significant AL is defined in the ALPrES²MA study as any leakage dehiscence, insufficiency, failure of the colon anastomosis that meets the criteria of Grade B or Grade C leakage, as follows: Grade B Leakage: Requires active therapeutic intervention such as administration of antibiotics, endosponge, image-guided percutaneous drainage (e.g., pelvic drain), or transanal lavage.; Does not require reoperation (i.e., is managed non-surgically).; Includes intra-abdominal abscesses directly related to the anastomosis. Grade C Leakage: Necessitates surgical re-intervention (e.g., re-laparotomy or reoperation) due to clinical deterioration or failure of conservative management.; Represents the most severe spectrum of AL. Clinically non-significant AL is as a Grade A leakage: a radiological or clinical finding that does not require a change in management.; Isolated abscesses near the anastomosis that do not require intervention beyond standard postoperative care.	From enrollment to the end of follow-up (12 months)
Incidence of delayed anastomotic leakage (AL)	Incidence of late or delayed anastomotic leakage, grade B or C, following elective colon resection.	From 90 days after the colon surgery untill the end of follow-up (12 months)
The incidence of grade A anastomotic leakage (AL)	Incidence of grade A AL or Isolated abscesses near the anastomosis that do not require intervention beyond standard postoperative care.	From enrollment to the end of follow-up (12 months)
Mesenteric Artery Calcification Score (MACS)	MACS of aortic and mesenteric arteries on preoperative CT scan. Absolute risk: Low MACS (<29.7) Intermediate MACS (29.7-422) High MACS (>422) Based on "Terlouw LG, van Noord D, van Walsum T, Bruno MJ, Moelker A. Mesenteric artery calcium scoring: a potential screening method for chronic mesenteric ischemia. Eur Radiol. 2020;31(6):4212-20."	At enrollment
quantitative Fluorescence Angiography (qFA) with Indocyanine Green (ICG)	The ALPrES²MA study will explore the use of qFA with ICG fluorescence. qFA will be used to measure anastomotic microcirculation and its association with AL. Fluorescence imaging incorporates the visualization of a fluorescent contrast agent in tissue. Contrast agent ICG has fluorescent properties in the near-infrared (NIR) region of the light spectrum. The fact that NIR light can penetrate through tissue makes visualization possible. When ICG is injected intravenously it follows the bloodstream to all organs in the body. This makes the local assessment of tissue perfusion possible. Since the interpretation of fluorescence angiography images is difficult and subjective, algorithms have been developed to quantify perfusion parameters based on fluorescent intensity-over-time curves (qFA). In thid study qFA is used to evaluate the impact of SMA stenting on colonic microperfusion and to investigate whether lower qFA values are associated with an increased incidence of AL.	Intra-operative
Operation time	Operation time of the colon resection in minutes.	intra-operative
Anastomotic Leakage related complications	All anastomotic related additional treatments and re-intervention within study period post-operative classified in the Clavien-Dindo classification	From enrollment to the end of follow-up (12 months)
Non-AL related additional treatment and re-intervention	Additional treatment and re-intervention which are not related to AL classified in the Clavien-Dindo classification.	From enrollment to 30 days post-operative.
Complications related to the colon surgery	All complications related to the colon surgery classified with Clavien-Dindo classification within 30 days post-operative.	From colon surgery untill 30 days post-operative.
Length of hospital stay	Duration of primary post-operative hospital stay and readmissions in days within the follow-up period of 12 months.	From enrollment to the end of follow-up (12 months).
Mortality	Post-operative mortality within the follow-up period of 12 months.	From enrollment untill the end of follow-up (12 months)
Quality of life (QoL)	Quality of life measured with the WHO-QoL-Bref survey The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is scored across four domains (Physical Health, Psychological, Social Relationships, and Environment). Each domain score is transformed to a scale ranging from 0 to 100, where higher scores indicate a better quality of life (better outcome). Items are rated on a 5-point Likert scale, and domain scores are transformed to a 0-100 scale according to the WHOQOL-BREF scoring guidelines, with higher scores reflecting better perceived quality of life.	Preoperative (-2 weeks) and after 3, 6, 9, and 12 months post operative.
Health related Quality of Life	Health related quality of life measured with the EQ-5D-5L survey. Health-related quality of life was measured using the EQ-5D-5L. This instrument describes health across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. Responses are converted into a utility score based on a country-specific value set, typically ranging from values below 0 (worse than death) to 1 (full health). Higher scores indicate a better health-related quality of life. In addition, the EQ-5D-5L includes a visual analogue scale (EQ VAS), which ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better perceived health. This is based on a dutch value set.	Preoperative (-2 weeks) and after 3, 6, 9, and 12 months post operative.
Healthcare Consumption	Healthcare consumption measured with the institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ). Healthcare utilization was measured using the iMTA Medical Consumption Questionnaire (iMCQ). This instrument assesses healthcare use (e.g., visits to healthcare providers, hospitalizations, medication use) over a specified recall period. The iMCQ does not yield a single overall scale score with a defined minimum or maximum. Instead, responses are reported as frequencies or volumes of healthcare utilization, where higher values indicate greater healthcare consumption.	Preoperative (-2 weeks) and after 3, 6, 9, and 12 months post operative.
Productivity Losses	Productivity losses measured with the iMTA Productivity Costs Questionnaire (iPCQ) Productivity losses were measured using the iMTA Productivity Cost Questionnaire (iPCQ). This instrument assesses productivity losses related to health problems, including absenteeism (work absence), presenteeism (reduced productivity while at work), and losses in unpaid work over a specified recall period. The iPCQ does not yield a single overall scale score with a defined minimum or maximum. Instead, outcomes are reported as the number of days or hours of productivity loss, where higher values indicate greater productivity losses and thus a worse outcome.	Preoperative (-2 weeks) and after 6 weeks, 3, 6, 9 and 12 months post operative.
Cost-Effectiveness	Cost-effectiveness expressed as the incremental cost-utility ratio (ICUR) of preventive stenting of a >50% origin SMA stenosis prior to an elective colon resection, compared to no preventive stenting prior to an elective colon resection, from a societal perspective over a 12-month time horizon.	From enrollment untill the end of follow-up (12 months)
Budget Impact Analysis to access the budget impact for the dutch society for the intervention	Budget impact analysis evaluating the impact of increasing nationwide implementation of preventive stenting of a >50% origin SMA stenosis prior to an elective colon resection, from a societal, governmental, and health insurance company's perspective. The outcome measure concerns a cost calculation based on multiple standardized instruments and intervention-related data. Specifically, healthcare costs will be assessed using the iMTA Medical Consumption Questionnaire and productivity-related costs using the iMTA Productivity Cost Questionnaire. In addition, all intervention-related costs (e.g., implementation, materials, and personnel) will be included. Based on these data, a budget impact analysis will be performed for the total population. Outcomes will be expressed in monetary units, where higher values indicate higher total costs.	From enrollment untill the end of follow-up (12 months)
Endovascular Stenting Complications	Only for the intervention group: All percutaneous transluminal angioplasty (PTA)/covered stent related AE and SAE including reinterventions post PTA	From PTA untill the end of follow-up (12 months)
Access Site Complications	Only for the intervention group: Access site AE and SAE of the PTA	From PTA untill the end of follow-up (12 months)
Hospital Stay after PTA	Only for the intervention group: Duration of primary post PTA hospitalisation and readmission within 30 days	From the PTA untill 30 days after.
PTA related mortality	Only for the intervention group: 30 day post PTA related mortality.	From PTA untill 30 days after.
Inability to perform colon resection.	Only for the intervention group: Inability to perform the colon resection due to complications arising from the study intervention: preventive endovascular stenting of the >50% SMA stenosis. The period from inclusion to end of follow-up (2 years). The delay of the colon resection in days.	From enrollment untill the colon surgery
Stent Patency	GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis patency determined with CTa or Duplex.	12 months after PTA

Collaborators and Investigators

• Sponsor: Medisch Spectrum Twente
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Franciscus Gasthuis; Ziekenhuisgroep Twente; University of Twente
• Investigators: Principal Investigator: Bob H. Geelkerken, Prof. dr., Medisch Spectrum Twente; Principal Investigator: Desiree van Noord, dr., Franciscus; Study Chair: Koen J. Vree Egberts, MD, PhD Candidate, Medisch Spectrum Twente & Franciscus

Publications and helpful links

General Publications

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
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Helpful Links

• Dutch Mesenteric Ischemia Study Group

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal surgery; Anastomotic leakage; Percutaneous transluminal angioplasty; Preventive intervention; Superior Mesenteric Artery Stenosis; Endovascular stenting
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anastomotic Leak; carbaspirin calcium
• Other Study ID Numbers: NL-010558 • PI-01.05, R25.103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No