Laser Speckle Contrast Imaging for Rectal Anastomotic Evaluation (LIRA): A Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging
研究概览
简要总结
This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
This is an open-label trial. Participants, surgeons, and other study personnel are aware of the study procedures. However, the LSCI measurements are not available to the surgeons during the surgical procedure and are only revealed after completion of the surgery. Therefore, the LSCI measurements cannot influence the surgeons' intraoperative decision-making regarding creation of the rectal anastomosis.
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
- •Rectal cancer
- •Surgical strategy either partial or total mesorectal excision
- •Able to provide informed consent
排除标准
- •- Allergy to iodine
研究组 & 干预措施
Intraoperative aided assessment of intestinal microcirculation
Participants undergoing total mesorectal excision (TME) for rectal cancer will undergo intraoperative assessment of rectal perfusion using laser speckle contrast imaging (LSCI) and indocyanine green fluorescence imaging (ICG-FI). Four to six days after TME, all participants will undergo computed tomography (CT) with intravenous contrast and a rectal contrast enema to assess for anastomotic leakage.
Participants must be older than 18 years of age and provide informed consent prior to inclusion.
干预措施: Laser speckle contrast imaging (Device)
结局指标
主要结局
Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging
时间窗: Intraoperatively
Feasibility is considered demonstrated if time spent on PerfusiX-Imaging measurements is ≤ 5% of total operating time and no more than two measurements are required to obtain a sufficient assessment of intestinal microcirculation. Unit: Percentage of participants with succesful assessment
Surgeon-reported acceptability of PerfusiX-Imaging
时间窗: intraoperatively
Surgeons will assess the acceptability and performance of PerfusiX-Imaging using a predefined Likert-scale questionnaire. Feasibility will be considered demonstrated if \>80% of surgeons report a positive evaluation of PerfusiX-Imaging. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. Unit: Percentage of surgeons with a positive evaluation
Potential impact of PerfusiX-Imaging on surgical decision making
时间窗: Intraoperatively
The distance between the marked oral transection line with and without the use of PerfusiX-Imaging given by the surgeon and an independent expert. Feasibility will be considered demonstrated if the transection line differs by ≥ 10 mm. Unit: milimetres (mm)
次要结局
- Comparison of surgeon-reported acceptability between PerfusiX-Imaging and ICG-FI(Immediately after surgery)
- Absolute intestinal microcirculation(Intraoperatively)
- Relative intestinal microcirculation(Intraoperatively)
- Length of initial hospital stay after surgery(From the end of surgery until initial hospital discharge, up to 30 days after surgery)
- Severity of postoperative complications according to the Clavien-Dindo classification(30 days after surgery)
- Surgical complications within 30 days after surgery(30 days after surgery)
- Medical complications within 30 days after surgery(30 days after surgery)
- Anastomotic leakage within 30 days of surgery(30 days after surgery)