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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with prostate cancer undergoing RARP.
Exclusion Criteria
- •Neoadjuvant androgen deprivation therapy before RARP.
- •Lack of consent for study participation or willingness to comply with all procedures and assessments.
Outcomes
Primary Outcomes
Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire)
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.
Secondary Outcomes
- Angle between the pubic bone and the prostate(Preoperatively)
- Pubic symphysis-prostate apex length (PAL)(Preoperatively)
- Membranous urethral length (MUL)(Preoperatively)
- Protrusion of the prostate into the bladder(Preoperatively)
- Anteroposterior diameter of the pelvic inlet (API)(Preoperatively)
- Pelvic depth (PD)(Preoperatively)
- The anteroposterior distance at the midpelvis (APM)(Preoperatively)
- Pelvic outlet (APO)(Preoperatively)
- Anteroposterior diameter of the working space during surgery (Workspace AP)(Preoperatively)
- Transevrse diameter of the working space during surgery (Workspace T)(Preoperatively)