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.
Age 18 years or older
Elective right colectomy for histologically confirmed or clinically or radiologically suspected operable right-sided colon cancer
Planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75
Capacity to understand the study and provide written informed consent
Emergency surgery
No planned or performed primary anastomosis
Another anastomotic technique or stapler model
Withdrawal or inability to consent
Adults scheduled for elective right colectomy for operable right-sided colon cancer with planned primary Barcelona ileotransverse anastomosis using NTLC75/SR75.
Cohort
Prospective
Passive External NTLC75 Handle-Signal Recording
Other interventionAn 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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
