Department of Urology and Urological Oncology
Szczecin, 70-123, Poland
NCT Number: NCT06985004
The goal of this observational study is to learn about the factors that affect the course of robot-assisted radical prostatectomy and have an impact on functional and oncological outcomes in patients undergoing RARP. The main question it aims to answer is:
• Can the investigators predict the occurrence of operational difficulties and outcomes of RARP based on preoperative assessment including body habitus and pelvimetry?
Participants undergoing RARP will be assessed preoperatively with the use of a PIODO Questionnaire, a structured protocol of preoperative assessment focusing on clinical data and MRI pelvic measurements to evaluate if the investigators can predict the risk of operational difficulties and possible outcomes of RARP. In a 1 year follow-up the investigators will collect data on functional and oncological outcomes.
This study is active but is not currently recruiting participants.
Notify MeMale
Observational
Szczecin, 70-123, Poland
Various factors affect the course of RARP and have an impact on functional and oncological outcomes. To date, no structured protocol has been developed for the preoperative assessment of patients undergoing RARP that evaluates not only clinical data on the prostate cancer, but also patient characteristics, including anthropometric measurements of the pelvis. Based on our previous research and preliminary study, the investigators have developed a PIODO Questionnaire to assess these factors and verify whether it is possible to predict the occurrence of operative difficulties as well as functional and oncological outcomes.
Participants undergoing RARP will be assessed preoperatively using the PIODO Questionnaire. The investigators will collect medical data and pelvic MRI measurements to evaluate if the investigators can predict the risk of operational difficulties and possible outcomes of RARP. In a 1-year follow-up, the investigators will obtain information on potency and continence, as well as the presence of biochemical recurrence.
Achieving our goal will allow us to facilitate counselling of patients on their relative likelihood of post-operative continence or erectile function based on individual factors and anthropometric measurements and allow urologists to predict operative difficulties they may face during surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An original PIODO Questionnaire is a structured protocol that has been developed by the investigators of this study for the preoperative assessment of patients undergoing RARP. It evaluates not only clinical data on the prostate cancer, but also patient characteristics, including anthropometric measurements of the pelvis. The aim is to develope a tool that can be used to predict the risk of operational difficulties and possible outcomes of RARP.
Time frame: Preoperatively
Preoperative assessment of patients undergoing RARP using an original questionnaire. The sum of the points obtained is presented as a number. The minimum value is 10 and maximum value is 34. The investigators' assumption is that the higher the score, the more difficult the surgery and the worse the functional and oncological outcome.
Time frame: Preoperatively
The angle between the pros¬tatic urethra and the posterior side of the pubic bone. Measured in degrees on MRI T2-weighted images.
Time frame: Preoperatively
The distance between the extension lines of the suprapubic ridge line and the prostate apical line. Measured in centimeters on MRI T2-weighted images.
Time frame: Preoperatively
The upper limit of MUL is the lower border of the peripheral zone of the prostate, dorsal to the membranous urethra. The lower limit of MUL is the origin of the penile base at the dorsal side of the urethral lumen. Measured in milimeters on MRI T2-weighted images.
Time frame: Preoperatively
Evaluation of the presence or absence of protrusion of the prostate into the bladder. If the tip of the prostate protruded to the base of the urinary bladder, protrusion of the prostate into the bladder was considered present. Measured in milimeters on MRI T2-weighted images.
Time frame: Preoperatively
Diameter from the sacral promontory to the most superior aspect of the pubic symphysis. Measured in centimeters on MRI T2-weighted images.
Time frame: Preoperatively
Diameter from the sacral promontory to the most inferior point of the pubic symphysis. Measured in centimeters on MRI T2-weighted images.
Time frame: Preoperatively
Diameter from the inferior aspect of the pubic symphysis to the sacrococcygeal junction. Measured in centimeters on MRI T2-weighted images.
Time frame: Preoperatively
Diameter from the inferior aspect of the pubic symphysis to the tip of the coccyx. Measured in centimeters on MRI T2-weighted images.
Time frame: Preoperatively
Diameter from anterior peritoneum to anterior border of coccyx (inner border). Measured in centimeters on MRI T2-weighted images.
Time frame: Preoperatively
Diameter between medial border of acetabulum. Measured in centimeters on MRI T2-weighted images.
Time frame: Preoperatively and in 1 year follow-up after RARP.
Measured with the use of International Index of Erectile Function-5 (IIEF-5). The minimum value is 0 and maximum value is 25. The higher the score the better erectile function.
Time frame: Preoperatively and in 1 year follow-up after RARP.
Presence of sexual activity marked as 1, lack of sexual activity marked as 0.
Time frame: Preoperatively
Presence of LUTS marked as 1, lack of symptoms marked as 0.
Time frame: Preoperatively and in 1 year follow-up after RARP.
Prostate-specific antigen (PSA) serum level.
Time frame: Preoperatively
Prostate volume based on the MRI scan in milliliters.
Time frame: Preoperatively
Measured using Prostate Imaging Reporting and Data System (PI-RADS) assessment categories.
Time frame: Preoperatively and up to 4 weeks after the surgery.
Histological grading of adenocarcinoma of the prostate, including use of the International Society of Urological Pathology (ISUP) modified Gleason grades. The minimum value us 1 and maximum value is 5. The higher the score the more advanced cancer.
Time frame: Preoperatively
Stage based on digital rectal examination (DRE) only in accordance with the EAU guidelines.
Time frame: Preoperatively
Weight and height will be combined to report body mass index (BMI) in kg/m^2
Time frame: Preoperatively
List of patients comorbidities.
Time frame: Preoperatively
Medications that can affect continence and/or erectile function - 1 if used, 0 if not.
Time frame: Intraoperatively
Operative difficulties were defined as:
Time frame: In 90 days follow-up after RARP.
Precence of postoperative complications during first 90 days after RARP - 1 if occured, 0 if not.
Time frame: In 1 year follow-up after RARP.
Measured with the Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC). The minimum value is 6 and maximum value is 28. The higher score the worse continence.
Pomeranian Medical University Szczecin
Other
Predicting Operational Difficulties and Outcomes of Robot-Assisted Radical Prostatectomy (RARP) Based on Preoperative Assessment - Introducing the PIODO (Preoperative Index for Operative Difficulties and Outcomes) Questionnaire
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