Relative Mechanical Resistance Curves of the NTLC75 Linear Stapler During Barcelona Ileotransverse Anastomosis After Right Colectomy: A Prospective Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participants With a Technically Valid Final Cross-Stapling Signal Record
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Elective Right Colectomy Cohort
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.
干预措施: Passive External NTLC75 Handle-Signal Recording (Other)
结局指标
主要结局
Participants With a Technically Valid Final Cross-Stapling Signal Record
时间窗: Intraoperative, during the final cross-stapling activation
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
时间窗: Postoperative day 3
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.
次要结局
- CloseMax During Small-Bowel Close-Only Calibration(Intraoperative, during the small-bowel close-only calibration)
- Maximum Signal Amplitude During ITA and Final Cross-Stapling Activations(Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations)
- Inter-Rater Agreement for Manual Curve Classification(Through study completion and before database lock, an anticipated 16 months)
- C-Reactive Protein Concentration(Postoperative days 1 and 3)
- Highest Clavien-Dindo Complication Grade(From the index operation through postoperative day 90)
- Participants With Anastomosis-Related Events(From the index operation through postoperative day 90)
- Length of Postoperative Hospital Stay(From the index operation to discharge from the index hospitalization, assessed through postoperative day 90)
- CloseMax During Colon Close-Only Calibration(Intraoperative, during the colon close-only calibration)
- CloseMax During Ileotransverse Anastomotic Channel Formation(Intraoperative, during the stapler activation forming the ileotransverse anastomotic channel)
- CloseMax During Final Cross-Stapling(Intraoperative, during the final cross-stapling activation)
- Normalized Time to Maximum Signal Amplitude(Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations)
- Signal-Branch Duration During ITA and Final Cross-Stapling Activations(Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations)
- Signal Peak Count During ITA and Final Cross-Stapling Activations(Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations)
- Maximum Signal Slope During ITA and Final Cross-Stapling Activations(Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations)
- Area Under the Signal Curve During ITA and Final Cross-Stapling Activations(Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations)
- Signal Amplitude Variability During ITA and Final Cross-Stapling Activations(Intraoperative, during the ileotransverse anastomotic-channel and final cross-stapling activations)
- Leukocyte Count(Postoperative days 1 and 3)
- Neutrophil Count(Postoperative days 1 and 3)
- Lymphocyte Count(Postoperative days 1 and 3)
- Neutrophil-to-Lymphocyte Ratio(Postoperative days 1 and 3)
- Serum Albumin Concentration(Postoperative days 1 and 3)
- Serum Creatinine Concentration(Postoperative days 1 and 3)
- Estimated Glomerular Filtration Rate(Postoperative days 1 and 3)
- Participants With a Major Postoperative Complication(From the index operation through postoperative day 90)
- Comprehensive Complication Index Score(From the index operation through postoperative day 90)
- Participants With All-Cause Readmission Within 30 Days(From discharge after the index hospitalization through postoperative day 30)
- Participants Undergoing Reoperation Within 30 Days(From the index operation through postoperative day 30)
- All-Cause Mortality Within 30 Days(From the index operation through postoperative day 30)
- All-Cause Mortality Within 90 Days(From the index operation through postoperative day 90)
研究者
Ognjen Barčot, MD, PhD
Assistant Professor, Department of Surgery
University Hospital of Split