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

January 4, 2024 updated by: IHU Strasbourg

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67 091
        • Service de Chirurgie Digestive et Endocrinienne, NHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
up to 7 days post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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
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
up to 7 days post procedure
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
up to 30 days post procedure
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
up to 30 days post procedure
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
up to 30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IHU Strasbourg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Didier Mutter, MD, PhD, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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