Clinical Trial Radar

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.

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