NCT03806244终止不适用
Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer
IHU Strasbourg2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Accuracy of Surgical stereotactic navigation defined as the distance, in millimetres, between the position of the surgical landmark and the position determined by the navigation system
研究概览
简要总结
To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.
详细描述
- In minimally invasive surgery, the proper identification of the correct anatomical planes can be difficult due to a lack of tactile feedback and the inability to manually palpate the organ prior to resection. Although this can be minimized by careful preoperative planning, the information that can be obtained by images is also of limited utility. Conventional imaging, such as magnetic resonance imaging (MRI) and computed tomography (CT-scan), can provide a detailed view of 2D or 3D internal anatomical structures. However, during surgery, surgeons still have to use their subjective interpretation to translate this information into three-dimensional spatial relationships (ie the patient's actual volume). For this reason, in order to perform adequate resection and avoid injury, the surgeon must constantly infer what is the actual location of the anatomical structures and what is the position of the surgical instruments in relation thereto.
- The proposed study aims to evaluate the feasibility of surgical navigation in patients with colorectal cancer (sigmoid rectum-right-left rectum) and measure its performance in the perspective of a more specific application to rectal cancer approached laparoscopically through the abdomen and / or the anus. The study is proposed to patients with cancer because the measurement of accuracy will be done on predefined anatomical points that will be detectable in the surgical field after oncologic dissection. Benign pathologies do not require this type of extensive dissection and the application of navigation would imply additional risks for patients.
- Surgical navigation will be performed on the basis of preoperative images or intraoperative images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patient is over 18 years old
- •Patient presents with cancer
- •Patient has no contraindication to anesthesia and surgical resection
- •Patient able to receive and understand information about the study and give written informed consent
- •Patient (s) affiliated to the national social security system.
排除标准
- •Patient operated on urgently.
- •Pregnant or lactating patient
- •Patient in an exclusion period (determined by previous or current study).
- •Patient under the protection of justice.
- •Patient under guardianship or curatorship.
结局指标
主要结局
Accuracy of Surgical stereotactic navigation defined as the distance, in millimetres, between the position of the surgical landmark and the position determined by the navigation system
时间窗: up to 7 days post procedure
Measurement of "accuracy" of surgical navigation defined as the distance measured between the position of "surgical" previously defined anatomical landmarks, pointed with a surgical instrument tracked by the navigation system, and corresponding location of the instrument in the navigation image. A distance equal to or less than 4 mm between the two locations will be considered as an optimum accuracy.
次要结局
- Comparison, in millimeters, of the surgical navigation "accuracy" (as defined in the primary outcome) with or without intraoperative images acquisition(up to 7 days post procedure)
- Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition(up to 30 days post procedure)
- Difference, in millimetres, between the alignment of the geometric position of the markers in the image space and the actual physical space for stereotaxic navigation(up to 7 days post procedure)
- Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition(up to 30 days post procedure)
- Number of intra and/or postoperative complication(up to 30 days post procedure)
研究者
研究点 (2)
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