Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

Study Overview
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Brief Summary
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To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

Detailed Description
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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.

Official Title
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Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Intraoperative acquisition (robotic c-Arm) of images


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: PREOP<br>Navigation without intraoperative acquisition of images: Use of conventional preoperative images (CT-MRI) to establish intraoperative navigation. | |
| Experimental: PEROP<br>Navigation with intraoperative acquisition of images: Intraoperative acquisition (robotic c-Arm) of images to establish intraoperative navigation. | Other: Intraoperative acquisition (robotic c-Arm) of images<br>* Conventional laparoscopic colorectal oncologic resection is performed. During the procedure, the operator will identify previously defined anatomical landmarks, point them with an instrument tracked by the navigation system and the accuracy of the stereotactic navigation system will be calculated by comparing the surgical anatomical point and its correspondent on the images of the navigation platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | up to 7 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison, in millimeters, of the surgical navigation accuracy (as defined in the primary outcome) with or without intraoperative images acquisition | Usefulness of intraoperative images acquisition for the registration process of the navigation system by comparing accuracy of surgical navigation (in mm) with or without intraoperative images acquisition | up to 7 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 | Measurement of registration error during surgical navigation defined as the difference between the alignment of the geometric position of the markers in the image space and the actual physical space, with or without intraoperative images acquisition. An error of 2 mm during the recording process will be considered as the optimal parameter | up to 7 days post procedure | 
| Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition | Evaluation of the impact of the introduction of surgical navigation on the operating time. The measurement of the overall operating time (expressed in minutes), associated with surgical navigation | up to 30 days post procedure | 
| Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition | Evaluation of the impact of the introduction of surgical navigation on the exposure of the patient to ionizing radiation, measured with Dose Length Product (DLP) and expressed in mGy * cm | up to 30 days post procedure | 
| Number of intra and/or postoperative complication | Evaluation of the impact of the introduction of surgical navigation on the incidence of intra- and / or postoperative complications associated with surgical navigation | up to 30 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic navigation, colorectal cancer, laparoscopy, transanal surgery