[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654462":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":56,"interventions":63,"overallOfficials":48,"centralContacts":69,"locations":75,"responsibleParty":105,"collaborators":107,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":48,"enrollmentInfo":122,"targetDuration":48,"studyType":125,"phases":126,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":137,"whyStopped":48,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"University of Aarhus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":48},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging","Feasibility is considered demonstrated if time spent on PerfusiX-Imaging measurements is ≤ 5% of total operating time and no more than two measurements are required to obtain a sufficient assessment of intestinal microcirculation.\n\nUnit:\n\nPercentage of participants with succesful assessment","Intraoperatively",{"measure":14,"description":15,"timeFrame":16},"Surgeon-reported acceptability of PerfusiX-Imaging","Surgeons will assess the acceptability and performance of PerfusiX-Imaging using a predefined Likert-scale questionnaire. Feasibility will be considered demonstrated if \\>80% of surgeons report a positive evaluation of PerfusiX-Imaging. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions.\n\nUnit:\n\nPercentage of surgeons with a positive evaluation","intraoperatively",{"measure":18,"description":19,"timeFrame":12},"Potential impact of PerfusiX-Imaging on surgical decision making","The distance between the marked oral transection line with and without the use of PerfusiX-Imaging given by the surgeon and an independent expert. Feasibility will be considered demonstrated if the transection line differs by ≥ 10 mm.\n\nUnit: milimetres (mm)",[21,25,28,31,35,39,42,45],{"measure":22,"description":23,"timeFrame":24},"Comparison of surgeon-reported acceptability between PerfusiX-Imaging and ICG-FI","Surgeons will assess the acceptability and performance of PerfusiX-Imaging and ICG-FI using a predefined Likert-scale questionnaire. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. The proportion of surgeons providing a positive evaluation of PerfusiX-Imaging will be compared with the proportion providing a positive evaluation on ICG-FI.\n\nUnit of measure:\n\nProportion of surgeons","Immediately after surgery",{"measure":26,"description":27,"timeFrame":12},"Absolute intestinal microcirculation","Intestinal microcirculation will be quantified using laser speckle contrast imaging (LSCI). Absolute microcirculation will be expressed as the mean laser speckle perfusion unit (LSPU) value obtained from a predefined region of interest (ROI) close to the intestinal anastomotic line.\n\nUnit of measure:\n\nLaser speckle perfusion units, LSPU",{"measure":29,"description":30,"timeFrame":12},"Relative intestinal microcirculation","Relative intestinal microcirculation will be calculated by normalizing the mean LSPU value from a region of interest to the mean LSPU value obtained from a reference region on the intestines:\n\nUnit of measure:\n\nPercentage (%): measurement\u002Fcontrol\\*100",{"measure":32,"description":33,"timeFrame":34},"Length of initial hospital stay after surgery","Length of initial hospital stay after surgery will be calculated as the number of hours from the end of surgery until initial discharge from hospital. The association between length of initial hospital stay after surgery and quantitative measurements of intestinal microcirculation will be explored.\n\nUnit of measure:\n\nHours","From the end of surgery until initial hospital discharge, up to 30 days after surgery",{"measure":36,"description":37,"timeFrame":38},"Severity of postoperative complications according to the Clavien-Dindo classification","Postoperative complications occuring within 30 days after surgery will be graded according to the Clavien-Dindo classification (Grade I-V). The asociation between quatitative measurements of intestinal microcirculation and the severity of postoperative complications will be explored.\n\nUnits of measure:\n\nClavien-Dindo","30 days after surgery",{"measure":40,"description":41,"timeFrame":38},"Surgical complications within 30 days after surgery","The occurence of surgical complications within 30 days after surgery will be recorded. Surgical complications include bleeding, fascial dehiscence, postoperative ileus, surgical site infection, intraabdominal abscess, stoma related complications. The association between surgical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored.\n\nUnits of measure:\n\nParticipants with one or more surgical complications",{"measure":43,"description":44,"timeFrame":38},"Medical complications within 30 days after surgery","The occurence of medical complications within 30 days after surgery will be recorded. Medical complicatinos include stroke, myocardial infarction, heart failure, pneumonia, aspiration, respiratory failure, deep vein thrombosis, acute arterial insufficiency and sepsis. The association between medical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored\n\nUnits of measure:\n\nParticipants with one or more medical complications",{"measure":46,"description":47,"timeFrame":38},"Anastomotic leakage within 30 days of surgery","Occurrence of anastomotic leakage within 30 days after surgery will be recorded as a binary outcome (yes\u002Fno). The association between anastomotic leakage and quantitative measurements of intestinal microcirculation will be explored.\n\nUnits of measure:\n\nParticipants with anastomotic leakage",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":6,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"NA","SINGLE_GROUP","The primary objective of this clinical investigation is to assess the feasibility of performing laparoscopic laser speckle contrast imaging (LSCI) measurements of intestinal perfusion during rectal cancer surgery. Feasibility will be evaluated in terms of technical feasibility, usability and acceptability among surgeons, and potential influence on surgical decision-making. Secondary objectives include comparison of LSCI with indocyanine green fluorescence imaging, assessment of quantitative perfusion measurements, and exploration of associations between perfusion measurements and postoperative outcomes.",{"masking":54,"maskingDescription":55,"whoMasked":48},"NONE","This is an open-label trial. Participants, surgeons, and other study personnel are aware of the study procedures. However, the LSCI measurements are not available to the surgeons during the surgical procedure and are only revealed after completion of the surgery. Therefore, the LSCI measurements cannot influence the surgeons' intraoperative decision-making regarding creation of the rectal anastomosis.",[57],{"label":58,"type":59,"description":60,"interventionNames":61},"Intraoperative aided assessment of intestinal microcirculation","EXPERIMENTAL","Participants undergoing total mesorectal excision (TME) for rectal cancer will undergo intraoperative assessment of rectal perfusion using laser speckle contrast imaging (LSCI) and indocyanine green fluorescence imaging (ICG-FI). Four to six days after TME, all participants will undergo computed tomography (CT) with intravenous contrast and a rectal contrast enema to assess for anastomotic leakage.\n\nParticipants must be older than 18 years of age and provide informed consent prior to inclusion.",[62],"Device: Laser speckle contrast imaging",[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":48},"DEVICE","Laser speckle contrast imaging","Investigated device: PerfusiX-Imaging, LIMIS Development B.V., The Netherlands ICG-FI: Verdye, 0.2 mg\u002Fkg, Firefly® fluorescence imaging\n\nPerfusiX-Imaging is used Intracorporally prior to anal specimen transection, extracoporally prior to oral speciamen transection, intracorporally assessing the free bowel ends prior to anastomotic formation. ICG-FI is applied intracorporally assessing the free bowel ends prior to anastomotic formation.\n\nDiagnostic imaging: All participants undergo computed tomography with intravenous contrast and a rectal contrast enema.",[58],[70],{"name":71,"role":72,"phone":73,"phoneExt":48,"email":74},"Mai-Britt W. Ørntoft, MD, Ph.D, Ass. Professor","CONTACT","+45 61670561","mwo@clin.au.dk",[76,92],{"facility":77,"status":48,"city":78,"state":48,"zip":48,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Regional Hospital Gødstrup","Herning","Denmark","DK",{"type":82,"coordinates":83},"Point",[84,85],8.97662,56.13615,{"lat":85,"lon":84},[88],{"name":89,"role":72,"phone":90,"phoneExt":48,"email":91},"Nickolai M Kristensen, MD","+45 30335786","nickks@rm.dk",{"facility":93,"status":48,"city":94,"state":48,"zip":48,"country":79,"countryCode":80,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Sygehus Lillebælt, Vejle Hospital","Vejle",{"type":82,"coordinates":96},[97,98],9.5357,55.70927,{"lat":98,"lon":97},[101],{"name":102,"role":72,"phone":103,"phoneExt":48,"email":104},"Pernille Ø Larsen, MD, consultant","+45 79 40 56 04","pernille.oehlenschlager.larsen0@rsyd.dk",{"type":106,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[108,110],{"name":109,"class":6},"Gødstrup Hospital",{"name":111,"class":6},"Vejle Hospital","100654462","examination-of-rectal-blood-supply-during-rectal-cancer-surgery-using-laser-speckle-contrast-imaging-100654462",false,"NCT07799740","Examination of Rectal Blood Supply During Rectal Cancer Surgery Using Laser Speckle Contrast Imaging","Laser Speckle Contrast Imaging for Rectal Anastomotic Evaluation (LIRA): A Feasibility Study.","LIRA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Rectal cancer\n* Surgical strategy either partial or total mesorectal excision\n* Able to provide informed consent\n\nExclusion Criteria:\n\n\\- Allergy to iodine","ALL","18 Years",{"count":123,"type":124},100,"ESTIMATED","INTERVENTIONAL",[50],"This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.",[129,130,131,132,133],"Rectal Cancer","Total Mesorectal Excision","Laser Speckle Contrast Imaging","Indocyanine Green (ICG)","Optical Imaging",[66,135,130,136],"Rectal cancer","Indocyanine Green Fluorescent Imaging","NOT_YET_RECRUITING","2026-09-08",{"date":140,"type":141},"2026-09-11","ACTUAL",{"date":143,"type":124},"2026-09-01",{"date":145,"type":124},"2029-06-01",{"name":5,"class":6},2]