An observational study in Right Colon Cancer, sponsored by University Hospital of Split. Not yet recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University Hospital of Split · Observational
This prospective single-center pilot cohort will include 40 consecutive adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using an NTLC75/SR75 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.
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 40 is below the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University Hospital of Split is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults scheduled for elective right colectomy for operable right-sided colon cancer with planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults undergoing elective right colectomy with a Barcelona ileotransverse anastomosis using NTLC75/SR75 as standard clinical care. Relative mechanical signals are recorded passively during two close-only calibration closures without firing and two standard stapler activations.
Other: 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.
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.
Time frame: Intraoperative, during the final cross-stapling activation
C-Reactive Protein Concentration on Postoperative Day 3 in Relation to the Normalized Final Maximum Signal
Routine-care serum C-reactive protein in mg/L, 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.
Time frame: Postoperative day 3
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.
Time frame: Intraoperative, during the small-bowel close-only calibration
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.
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
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.
Time frame: Through study completion and before database lock, an anticipated 16 months
C-Reactive Protein Concentration
Routine-care serum C-reactive protein concentration recorded separately on postoperative days 1 and 3 and reported in mg/L. The prespecified association between postoperative-day-3 CRP and the normalized final cross-stapling maximum remains the second primary outcome.
Time frame: Postoperative days 1 and 3
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.
Time frame: From the index operation through postoperative day 90
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.
Time frame: From the index operation through postoperative day 90
Length of Postoperative Hospital Stay
Number of calendar days from the index operation to discharge from the index hospitalization.
Time frame: From the index operation to discharge from the index hospitalization, assessed through postoperative day 90
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.
Time frame: Intraoperative, during the colon close-only calibration
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.
Time frame: Intraoperative, during the stapler activation forming the ileotransverse anastomotic channel
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.
Time frame: Intraoperative, during the final cross-stapling activation
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.
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
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.
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
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.
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
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.
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
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.
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
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.
Time frame: Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations
Leukocyte Count
Routine-care peripheral blood leukocyte count recorded separately on postoperative days 1 and 3 and reported as ×10\^9/L.
Time frame: Postoperative days 1 and 3
Neutrophil Count
Routine-care peripheral blood absolute neutrophil count recorded separately on postoperative days 1 and 3 and reported as ×10\^9/L.
Time frame: Postoperative days 1 and 3
Lymphocyte Count
Routine-care peripheral blood absolute lymphocyte count recorded separately on postoperative days 1 and 3 and reported as ×10\^9/L.
Time frame: Postoperative days 1 and 3
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.
Time frame: Postoperative days 1 and 3
Serum Albumin Concentration
Routine-care serum albumin concentration recorded separately on postoperative days 1 and 3 and reported in g/L.
Time frame: Postoperative days 1 and 3
Serum Creatinine Concentration
Routine-care serum creatinine concentration recorded separately on postoperative days 1 and 3 and reported in µmol/L.
Time frame: Postoperative days 1 and 3
Estimated Glomerular Filtration Rate
Laboratory-reported estimated glomerular filtration rate recorded separately on postoperative days 1 and 3 and reported in mL/min/1.73 m².
Time frame: Postoperative days 1 and 3
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.
Time frame: From the index operation through postoperative day 90
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.
Time frame: From the index operation through postoperative day 90
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.
Time frame: From discharge after the index hospitalization through postoperative day 30
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.
Time frame: From the index operation through postoperative day 30
All-Cause Mortality Within 30 Days
Number and percentage of participants who die from any cause by postoperative day 30.
Time frame: From the index operation through postoperative day 30
All-Cause Mortality Within 90 Days
Number and percentage of participants who die from any cause by postoperative day 90.
Time frame: From the index operation through postoperative day 90
Plan to share: No — Patient-level data will not be made public because the small single-center surgical cohort carries a material re-identification risk.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Nov 2027, 13 months later.
Of 186 non-industry observational studies under Colonic Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 13 months is below that.
Counting every sponsor, half of 224 studies reached it within 50 months; a quarter within 24 and three quarters within 116.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University Hospital of Split