Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Right Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Passive External NTLC75 Handle-Signal Recording | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Elective Right Colectomy Cohort
- description
- 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.
- interventionNames
- Other: Passive External NTLC75 Handle-Signal Recording
Primary outcomes (2)
- measure
- Participants With a Technically Valid Final Cross-Stapling Signal Record
- timeFrame
- Intraoperative, during the final cross-stapling activation
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Emergency surgery * No planned or performed primary anastomosis * Another anastomotic technique or stapler model * Withdrawal or inability to consent * Intraoperative change of plan preventing the planned measurement procedure
References
Publications (0)
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