Prostate cancer Prostate carcinoma
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men undergoing robot assisted laparoscopic prostatectomy for * T2 prostate carcinoma, without neoadjuvant therapy
Exclusion criteria
Exclusion criteria: - Suspected oversensitivity to light; e.g. a patient who has had photodynamic therapy - History of radiotherapy in the pelvic area - History of abdominal surgery - History of neoadjuvant androgen deprivation therapy - Use of indocyanine green (ICG) injections prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the usability of a drop-in optical probe in terms quality of measurements and impact on current workflow. To assess the usability of the optical drop-in probe, we want to assess whether the drop-in optical probe can make tissue contact at all prostate surfaces. To measure this, we want to use single fiber reflectance measurements. These single fiber reflectance measurements are performed automatically and simultaneously with the diffuse reflection spectroscopy measurements and measure a high reflection if there is no adequate tissue contact. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameter is ease of use of a drop-in DRS probe as reported by surgeons. We intend to use the System Usability Scale (SUS-score) to assess the ease of use as reported by surgeons. For future research it is important to be able to mark the measurement locations, so that the measurement location can be traced back in pathology slides and so that it can be correlated to the acquired spectra. Therefor in this study we want to assess which method, a suture or a clip, can best be used to mark the measurement location in vivo and to find back the measurement location in the pathology slides. | — |
Countries
Netherlands
Outcome results
None listed