Clinical trial NCT03806244: Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer
Official title: Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Keywords: stereotactic navigation
colorectal cancer
laparoscopy
transanal surgery
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

1. Patient is over 18 years old
2. Patient presents with cancer
3. Patient has no contraindication to anesthesia and surgical resection
4. Patient able to receive and understand information about the study and give written informed consent
5. Patient (s) affiliated to the national social security system.

Exclusion Criteria:

1. Patient operated on urgently.
2. Pregnant or lactating patient
3. Patient in an exclusion period (determined by previous or current study).
4. Patient under the protection of justice.
5. Patient under guardianship or curatorship.

Primary outcomes:
measure: 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
timeFrame: up to 7 days post procedure
Secondary outcomes:
measure: Comparison, in millimeters, of the surgical navigation "accuracy" (as defined in the primary outcome) with or without intraoperative images acquisition
timeFrame: up to 7 days post procedure
measure: 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
timeFrame: up to 7 days post procedure
measure: Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition
timeFrame: up to 30 days post procedure
measure: Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition
timeFrame: up to 30 days post procedure
measure: Number of intra and/or postoperative complication
timeFrame: up to 30 days post procedure
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne, NHC
Study officials:
affiliation: Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
name: Didier Mutter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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