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Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis
Sponsor: University Hospital of Split
Summary
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.
Official title: Relative Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis After Right Colectomy: A Prospective Observational Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2026-10-01
Completion Date
2028-01-29
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
University Hospital of Split, Department of Surgery
Split, Croatia