[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657178":3},{"organization":4,"outcomesModule":7,"designInfo":116,"detailedDescription":119,"studyPopulation":120,"armGroups":121,"interventions":127,"overallOfficials":115,"centralContacts":132,"locations":138,"responsibleParty":153,"collaborators":115,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":158,"sex":164,"minAge":165,"maxAge":115,"enrollmentInfo":166,"targetDuration":115,"studyType":169,"phases":115,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":182,"whyStopped":115,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"University Hospital of Split","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":115},[9,13],{"measure":10,"description":11,"timeFrame":12},"Participants With a Technically Valid Final Cross-Stapling Signal Record","Number and percentage of all 40 enrolled participants with a complete and technically valid final cross-stapling signal record. A valid record includes a complete forward branch, an identifiable reference return branch, no peak-obscuring saturation, no loss of sensor contact, and successful application of the locked signal-processing algorithm. Missing or invalid records remain in the denominator. Prespecified feasibility target: at least 35 of 40 participants.","Intraoperative, during the final cross-stapling activation",{"measure":14,"description":15,"timeFrame":16},"C-Reactive Protein Concentration on Postoperative Day 3 in Relation to the Normalized Final Maximum Signal","Routine-care serum C-reactive protein in mg\u002FL, analyzed continuously in association with the normalized maximum amplitude of the final cross-stapling forward branch using a scatterplot, Pearson or Spearman correlation, and simple linear regression.","Postoperative day 3",[18,22,26,30,34,38,41,45,49,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101,105,109,112],{"measure":19,"description":20,"timeFrame":21},"CloseMax During Small-Bowel Close-Only Calibration","Maximum baseline-corrected relative signal amplitude during complete stapler closure on the double-walled small bowel located on the resection-specimen side, without firing. Reported in relative signal units.","Intraoperative, during the small-bowel close-only calibration",{"measure":23,"description":24,"timeFrame":25},"Maximum Signal Amplitude During ITA and Final Cross-Stapling Activations","Maximum baseline-corrected amplitude of each forward and return signal branch, calculated separately for the ileotransverse anastomotic-channel and final cross-stapling activations. Reported in relative signal units.","Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations",{"measure":27,"description":28,"timeFrame":29},"Inter-Rater Agreement for Manual Curve Classification","Two independent raters blinded to C-reactive protein values and clinical outcomes classify technical validity, curve morphology, sticking, and irregularity for the ileotransverse anastomotic-channel and final cross-stapling recordings. Agreement between the two initial categorical ratings is quantified using Cohen's kappa before consensus resolution.","Through study completion and before database lock, an anticipated 16 months",{"measure":31,"description":32,"timeFrame":33},"C-Reactive Protein Concentration","Routine-care serum C-reactive protein concentration recorded separately on postoperative days 1 and 3 and reported in mg\u002FL. The prespecified association between postoperative-day-3 CRP and the normalized final cross-stapling maximum remains the second primary outcome.","Postoperative days 1 and 3",{"measure":35,"description":36,"timeFrame":37},"Highest Clavien-Dindo Complication Grade","Highest Clavien-Dindo grade assigned to any postoperative complication experienced by each participant through postoperative day 90. Participants without a complication are recorded as having no Clavien-Dindo complication.","From the index operation through postoperative day 90",{"measure":39,"description":40,"timeFrame":37},"Participants With Anastomosis-Related Events","Number and percentage of participants with anastomotic leak, anastomotic bleeding, perianastomotic collection or abscess, anastomosis-related radiologic or endoscopic intervention, reoperation, or surgical revision. Each event type is reported separately.",{"measure":42,"description":43,"timeFrame":44},"Length of Postoperative Hospital Stay","Number of calendar days from the index operation to discharge from the index hospitalization.","From the index operation to discharge from the index hospitalization, assessed through postoperative day 90",{"measure":46,"description":47,"timeFrame":48},"CloseMax During Colon Close-Only Calibration","Maximum baseline-corrected relative signal amplitude during complete stapler closure on the double-walled colon located on the resection-specimen side, without firing. Reported in relative signal units.","Intraoperative, during the colon close-only calibration",{"measure":50,"description":51,"timeFrame":52},"CloseMax During Ileotransverse Anastomotic Channel Formation","Maximum baseline-corrected relative signal amplitude during the closing phase preceding the standard stapler activation used to form the ileotransverse anastomotic channel without cross-stapling. Reported in relative signal units.","Intraoperative, during the stapler activation forming the ileotransverse anastomotic channel",{"measure":54,"description":55,"timeFrame":12},"CloseMax During Final Cross-Stapling","Maximum baseline-corrected relative signal amplitude during the closing phase preceding the final cross-stapling activation. Reported in relative signal units.",{"measure":57,"description":58,"timeFrame":25},"Normalized Time to Maximum Signal Amplitude","Position of the maximum baseline-corrected amplitude within each signal branch, expressed as a percentage of that branch's total duration from 0% to 100%. Calculated separately for the forward and return branches of both activations.",{"measure":60,"description":61,"timeFrame":25},"Signal-Branch Duration During ITA and Final Cross-Stapling Activations","Actual elapsed duration of each forward and return signal branch, calculated separately for the ileotransverse anastomotic-channel and final cross-stapling activations. Reported in seconds from the preserved raw timestamps.",{"measure":63,"description":64,"timeFrame":25},"Signal Peak Count During ITA and Final Cross-Stapling Activations","Number of signal peaks identified by the locked signal-processing algorithm in each 200-point normalized-time branch. Calculated separately for the forward and return branches of both activations.",{"measure":66,"description":67,"timeFrame":25},"Maximum Signal Slope During ITA and Final Cross-Stapling Activations","Maximum positive slope of each 200-point normalized-time signal branch, calculated using the locked signal-processing algorithm. Reported in relative signal units per normalized-time point and calculated separately for both activations.",{"measure":69,"description":70,"timeFrame":25},"Area Under the Signal Curve During ITA and Final Cross-Stapling Activations","Area under each baseline-corrected 200-point normalized-time signal branch, calculated separately for the forward and return branches of both activations. Reported in relative signal units multiplied by normalized time.",{"measure":72,"description":73,"timeFrame":25},"Signal Amplitude Variability During ITA and Final Cross-Stapling Activations","Standard deviation of the baseline-corrected amplitudes across each 200-point normalized-time signal branch. Calculated separately for the forward and return branches of both activations and reported in relative signal units.",{"measure":75,"description":76,"timeFrame":33},"Leukocyte Count","Routine-care peripheral blood leukocyte count recorded separately on postoperative days 1 and 3 and reported as ×10\\^9\u002FL.",{"measure":78,"description":79,"timeFrame":33},"Neutrophil Count","Routine-care peripheral blood absolute neutrophil count recorded separately on postoperative days 1 and 3 and reported as ×10\\^9\u002FL.",{"measure":81,"description":82,"timeFrame":33},"Lymphocyte Count","Routine-care peripheral blood absolute lymphocyte count recorded separately on postoperative days 1 and 3 and reported as ×10\\^9\u002FL.",{"measure":84,"description":85,"timeFrame":33},"Neutrophil-to-Lymphocyte Ratio","Neutrophil-to-lymphocyte ratio calculated from the absolute neutrophil and lymphocyte counts obtained on the same postoperative day. Recorded separately on postoperative days 1 and 3 and reported as a unitless ratio.",{"measure":87,"description":88,"timeFrame":33},"Serum Albumin Concentration","Routine-care serum albumin concentration recorded separately on postoperative days 1 and 3 and reported in g\u002FL.",{"measure":90,"description":91,"timeFrame":33},"Serum Creatinine Concentration","Routine-care serum creatinine concentration recorded separately on postoperative days 1 and 3 and reported in µmol\u002FL.",{"measure":93,"description":94,"timeFrame":33},"Estimated Glomerular Filtration Rate","Laboratory-reported estimated glomerular filtration rate recorded separately on postoperative days 1 and 3 and reported in mL\u002Fmin\u002F1.73 m².",{"measure":96,"description":97,"timeFrame":37},"Participants With a Major Postoperative Complication","Number and percentage of participants experiencing at least one major postoperative complication, defined as Clavien-Dindo grade III, IV, or V.",{"measure":99,"description":100,"timeFrame":37},"Comprehensive Complication Index Score","Comprehensive Complication Index score calculated from all postoperative complications experienced by each participant through postoperative day 90. Reported on the standard continuous scale from 0, indicating no complication, to 100, indicating death.",{"measure":102,"description":103,"timeFrame":104},"Participants With All-Cause Readmission Within 30 Days","Number and percentage of participants with at least one unplanned all-cause hospital readmission by postoperative day 30.","From discharge after the index hospitalization through postoperative day 30",{"measure":106,"description":107,"timeFrame":108},"Participants Undergoing Reoperation Within 30 Days","Number and percentage of participants undergoing at least one unplanned surgical reoperation for any cause by postoperative day 30.","From the index operation through postoperative day 30",{"measure":110,"description":111,"timeFrame":108},"All-Cause Mortality Within 30 Days","Number and percentage of participants who die from any cause by postoperative day 30.",{"measure":113,"description":114,"timeFrame":37},"All-Cause Mortality Within 90 Days","Number and percentage of participants who die from any cause by postoperative day 90.",null,{"allocation":115,"interventionModel":115,"interventionModelDescription":115,"primaryPurpose":115,"observationalModel":117,"timePerspective":118,"maskingInfo":115},"COHORT","PROSPECTIVE","Two close-only calibration measurements will be recorded once on double-walled small bowel and colon located on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing or consuming additional reloads. The first standard activation forms the ileotransverse anastomotic channel without cross-stapling, with the anvil in the colon and reload jaw in the small bowel. The final closure is oriented with the device tip toward the small bowel so that knife travel proceeds from colon to small bowel and crosses two existing staple lines. The surgeon measures flattened tissue lengths and both cross-stapling distances with a sterile ruler to the nearest whole millimeter. Raw signals are preserved; forward and return branches are resampled to 200 normalized-time points. The signal is not calibrated as absolute force, is not shown to the surgeon and does not influence care. Other curve features and clinical outcomes are exploratory.","Adults scheduled for elective right colectomy for operable right-sided colon cancer with planned primary Barcelona ileotransverse anastomosis using NTLC75\u002FSR75.",[122],{"label":123,"type":115,"description":124,"interventionNames":125},"Elective Right Colectomy Cohort","Adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using NTLC75\u002FSR75 as standard clinical care. Relative mechanical signals are recorded passively during two close-only calibration closures without firing and two standard stapler activations.",[126],"Other: Passive External NTLC75 Handle-Signal Recording",[128],{"type":6,"name":129,"description":130,"armGroupLabels":131,"otherNames":115},"Passive External NTLC75 Handle-Signal Recording","An external DF9-40 sensor mounted on the NTLC75 handle passively records relative mechanical signals. One close-only calibration recording is obtained on double-walled small bowel and one on double-walled colon on the resection-specimen side, outside the tumor and resection margins, with the anvil toward the mesentery, without firing. Signals are also recorded during standard ITA channel formation (anvil in colon; reload jaw in small bowel; no cross-stapling) and final closure (tip toward small bowel; knife travel from colon to small bowel across two existing staple lines). The signal is not shown to the surgeon and does not affect clinical care.",[123],[133],{"name":134,"role":135,"phone":136,"phoneExt":115,"email":137},"Ognjen Barčot, MD, PhD","CONTACT","+385 21 556 691","ognjen.barcot@kbsplit.hr",[139],{"facility":140,"status":115,"city":141,"state":115,"zip":142,"country":143,"countryCode":144,"cosmosGeoPoint":145,"geoPoint":150,"contacts":151},"University Hospital of Split, Department of Surgery","Split","21000","Croatia","HR",{"type":146,"coordinates":147},"Point",[148,149],16.43915,43.50891,{"lat":149,"lon":148},[152],{"name":134,"role":135,"phone":136,"phoneExt":115,"email":137},{"type":154,"investigatorFullName":134,"investigatorTitle":155,"investigatorAffiliation":5,"oldNameTitle":115,"oldOrganization":115},"PRINCIPAL_INVESTIGATOR","Assistant Professor, Department of Surgery","100657178","mechanical-resistance-curves-of-the-ntlc75-linear-stapler-during-barcelona-ileotransverse-anastomosis-100657178",false,"NCT07834385","Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis","Relative Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis After Right Colectomy: A Prospective Observational Pilot Study","NTLC75-ITA","Inclusion Criteria:\n\n* Age 18 years or older\n* Elective right colectomy for histologically confirmed or clinically or radiologically suspected operable right-sided colon cancer\n* Planned primary Barcelona ileotransverse anastomosis using NTLC75\u002FSR75\n* Capacity to understand the study and provide written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* No planned or performed primary anastomosis\n* Another anastomotic technique or stapler model\n* Withdrawal or inability to consent\n* Intraoperative change of plan preventing the planned measurement procedure","ALL","18 Years",{"count":167,"type":168},40,"ESTIMATED","OBSERVATIONAL","This prospective single-center pilot cohort will include 40 consecutive adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using an NTLC75\u002FSR75 linear stapler. A sensor mounted externally on the stapler handle will record relative mechanical signals during two calibration closures without firing and two standard stapler activations. The main objectives are to obtain at least 35 technically valid final cross-stapling recordings and to estimate the association between the normalized final maximum signal and C-reactive protein on postoperative day 3. Clinical treatment is unchanged and follow-up continues through postoperative day 90.",[172],"Right Colon Cancer",[174,175,176,177,178,179,180,181],"NTLC75","Ileotransverse anastomosis","Barcelona technique","Linear stapler","Cross-stapling","Mechanical signal","C-reactive protein","Feasibility","NOT_YET_RECRUITING","2026-09-15",{"date":185,"type":186},"2026-09-22","ACTUAL",{"date":188,"type":168},"2026-10-01",{"date":190,"type":168},"2028-01-29",{"name":5,"class":6},1]