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Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer (PELVINAV)

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ClinicalTrials.gov Identifier: NCT03806244
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Intraoperative acquisition (robotic c-Arm) of images Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021
Arms and Interventions
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Arm Intervention/treatment
No Intervention: PREOP
Navigation without intraoperative acquisition of images: Use of conventional preoperative images (CT-MRI) to establish intraoperative navigation.
Experimental: PEROP
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. Comparison, in millimeters, of the surgical navigation "accuracy" (as defined in the primary outcome) with or without intraoperative images acquisition [ Time Frame: 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

  2. 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 [ Time Frame: 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

  3. Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition [ Time Frame: 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

  4. Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition [ Time Frame: 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

  5. Number of intra and/or postoperative complication [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806244


Contacts
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Contact: Armelle Takeda, PhD +33(0)390413608 armelle.takeda@chru-strasbourg.fr
Contact: Bernard Dallemagne, MD bernard.dallemagne@ircad.fr

Locations
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France
Service de Chirurgie Digestive et Endocrinienne, NHC Recruiting
Strasbourg, France, 67 091
Contact: Didier Mutter, MD, PhD    +33(0)3 69 55 05 53    didier.mutter@chru-strasbourg.fr   
Sponsors and Collaborators
IHU Strasbourg
Investigators
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Principal Investigator: Didier Mutter, MD, PhD Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
More Information
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Additional Information:

Publications:

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Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT03806244    
Other Study ID Numbers: 18-002
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IHU Strasbourg:
stereotactic navigation
colorectal cancer
laparoscopy
transanal surgery
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases