Trial document





This trial has been registered retrospectively.
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  DRKS00011147

Trial Description

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Title

A virtual reality environment using a head-mounted display for interactive and immersive 3D operation planning and training for complex rectal surgery: are there benefits? – study protocol for a prospective one-armed pilot trail

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Trial Acronym

IMHOTEP OP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The surgical removal of malignant rectal tumors is in most cases the only curative treatment. The surgeon has to rely on precise imaging and information from other medical fields (e.g. radiology, oncology, radiotherapy) in planning operations for low lying rectal tumors in close proximity to the anal sphincter. Sectional imaging (e.g. computed tomography and magnetic resonance imaging) is one of the most helpful tools, which aids the surgeon in preparing for the operation, carrying out measurements, visualizing the individual anatomy of the patient, assessing specific risks, taking surgical decisions and thinking through certain operational steps in advance.
At the moment radiological imaging data is displayed in stacked sectional views on a standard monitor. The fusion of anatomy, anomalies and pathological changes is solely dependent on the capacity for remembering and the spatial imagination of the operating surgeon. Particularly in rectal cancer surgery it is difficult to get a clear overview of the exact location and extent of the tumor, as well as its relation to the surrounding structures. Furthermore it is essential to know the location and distance of suspicious lymph nodes, which are present in the fatty tissue around the rectum, to the cutting plane during the operation.
Modern methods allow for a better, immersive and intuitive visualization of all relevant information (patient information, 3D-model of the organs and radiological imaging data) in a virtual reality environment. Particularly the three-dimensional visualization of imaging data is more intuitive. Three-dimensional operation planning in comparison to traditional two-dimensional methods proved beneficial in other complex surgical interventions (e.g. extended liver resections).
The present study will evaluate a system which can visualize the operating field of a rectal surgery patient in a three-dimensional, interactive, intuitive and immersive fashion with a head-mounted display (e.g. HTC Vive™ (HTC Corporation, New Taipei City, Taiwan). For this patient specific radiological imaging data (computed tomography or magnetic resonance imaging) will be used to create a 3D-model and integrated into a virtual reality environment with a virtual-reality (VR) headset. The operating field can be visualized realistically.
In this study we will evaluate to what extent surgeons, who are using this technology, can quickly and correctly identify patient individual anatomy and pathology and make a surgical decision. Furthermore the usefulness of this system for the operating team will be evaluated. Patients will be recruited from the patient collective of the surgical clinic of the University Clinic Heidelberg. Patients with low-lying rectal tumors with close proximity to the anal sphincter, who are planned for surgical resection, will be selected. These patients will be planned for surgery using traditional methods (sectional images viewed on a 2D-Monitor). Additionally, the operating team will preoperatively plan the operation in the virtual reality environment.
The evaluation is performed before and after the operation. Participants are surgeons of the University of Heidelberg. Firstly it will be evaluated whether it is feasible to visualize and assess the anatomy, pathology and operation-relevant information within the virtual reality environment. Secondly it will be evaluated how fast and well surgical decisions can be made with the virtual reality environment.
Furthermore subjective benefit, satisfaction, usefulness and potential of the visualization method will be assessed.

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Brief Summary in Scientific Language

Surgical resection is in most cases the only curative therapy for low-lying rectal neoplasms.The surgeon has to rely on precise (multimodal) imaging and information from other medical disciplines (e.g. radiology, oncology, radiotherapy) in planning operations for low lying rectal tumors in close proximity to the dentate line. Sectional imaging (e.g. computed tomography and magnetic resonance imaging) is one of the most helpful tools, which aids the surgeon in preparing for the operation, carrying out measurements, visualizing the individual anatomy of the patient, assessing specific risks, taking surgical decisions and thinking through certain operational steps in advance.
At the moment radiological imaging data is displayed in stacked sectional views on a standard monitor. The fusion of anatomy, anomalies and pathological changes is solely dependent on the capacity for remembering and the spatial imagination of the operating surgeon. Particularly in rectal cancer surgery it is difficult to get a clear overview of the exact location and extent of the tumor, as well as its relation to the surrounding structures. Furthermore it is essential to know the location and spread of mesorectal lymph nodes, as well as the distance to the mesorectal fascia intraoperatively.
Modern methods allow for a better, immersive and intuitive visualization of all relevant information (patient information, 3D-model of the organs and radiological imaging data) in a virtual reality environment. Particularly the three-dimensional visualization of imaging data is more intuitive. Three-dimensional operation planning in comparison to traditional two-dimensional methods proved beneficial in other complex surgical interventions (e.g. extended liver resections).
The present study will evaluate a system which can visualize the operating field of a rectal surgery patient in a three-dimensional, interactive, intuitive and immersive fashion with a head-mounted display (e.g. HTC Vive™ (HTC Corporation, New Taipei City, Taiwan). For this patient specific radiological imaging data (computed tomography or magnetic resonance imaging) will be used to create a 3D-model and integrated into a virtual reality environment with a virtual-reality (VR) headset. The operating field can be visualized realistically.
This is a prospective, monocentric, one-armed pilot trail. Participants are surgeons of the University of Heidelberg. Patients with low-lying rectal tumors with close proximity to the dentate line, who are planned for surgical resection, will be selected from the patient collective of the surgical clinic of the University Clinic Heidelberg. These patients will be planned for surgery using traditional methods (sectional images viewed on a 2D-Monitor). Additionally, the operating team will preoperatively plan the operation in the virtual reality environment. The evaluation is performed before and after the operation.
Preoperatively a score is determined with a 10-item-checklist capturing to what extent surgeons, who are using this technology, can correctly identify patient individual anatomy and pathology and make a surgical decision. The time to answer this checklist will be measured. Furthermore subjective benefit, satisfaction, usefulness and potential of the visualization method will be assessed using a 13-item-checklist. This checklist will also be filled out postoperatively. In this study we will evaluate to what extent surgeons, who are using this technology, can quickly and correctly identify patient individual anatomy and pathology and make a surgical decision. Furthermore the usefulness of this system for the operating team will be evaluated.

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Organizational Data

  •   DRKS00011147
  •   2016/12/07
  •   [---]*
  •   yes
  •   Approved
  •   S-348/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C18.9 -  Malignant neoplasm: Colon, unspecified
  •   C18.8 -  Malignant neoplasm: Overlapping lesion of colon
  •   C18.7 -  Malignant neoplasm: Sigmoid colon
  •   C18.6 -  Malignant neoplasm: Descending colon
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Interventions/Observational Groups

  •   A preopertive surgical evaluation of the patient with low rectal cancer is performed with a 3D-model within a virtual reality environment using a head-mounted display. The pseudonymized patient information is integrated into the virtual reality environment. This method is used additionally to the Standard preoperative planning with sectional imaging.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome measure is determining a score as measured by an 10-item-checklist with yes/no-, multiple-choice- and single-choice-questions. The checklist measures if relevant anatomy and pathology, anomalies and the relation between pathology and anatomy can be assessed and if the decision for a correct resection strategy can be made.

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Secondary Outcome

Secondary endpoints are the time it took to answer above mentioned checklist, as well as subjective benefit, satisfaction, usefulness and potential of this technology as assessed by an 13-item-checklist with Likert-scales, multiple-choice-questions and and free text.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/08/31
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

surgeons in general or visceral surgery,
patients that are operated at the University Clinic Heidelberg

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Exclusion Criteria

Patients, who do decline an Operation. On patitent demand.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Chirurgisches Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Hannes Götz  Kenngott 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Chirurgisches Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Hannes Götz  Kenngott 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Chirurgisches Universitätsklinikum Heidelberg
    • Mr.  Anas  Preukschas 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgisches Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Beat Peter  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.