Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

Not Applicable

Terminated

• Conditions: Colorectal Cancer
• Interventions: Other: Intraoperative acquisition (robotic c-Arm) of images

• Registration Number: NCT03806244
• Lead Sponsor: IHU Strasbourg

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.

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Start: 2019-07-17
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEROP	Intraoperative acquisition (robotic c-Arm) of images	Navigation with intraoperative acquisition of images: Intraoperative acquisition (robotic c-Arm) of images to establish intraoperative navigation.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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	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
Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition	up to 30 days post procedure	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
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 "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
Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition	up to 30 days post procedure	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
Number of intra and/or postoperative complication	up to 30 days post procedure	Evaluation of the impact of the introduction of surgical navigation on the incidence of intra- and / or postoperative complications associated with surgical navigation

Trial Locations

Locations (1)

Service de Chirurgie Digestive et Endocrinienne, NHC; 🇫🇷 Strasbourg, France