Clinical trial NCT06985004: Predicting Operational Difficulties and Outcomes of RARP Based on Preoperative Assessment - Introducing the PIODO Questionnaire
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Robot-Assisted Laparoscopic Radical Prostatectomy
Keywords: Prostate cancer
RARP
robot-assisted radical prostatectomy
preoperative assessment
pelvimetry
magnetic resonance imaging
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 288
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators included in the study population consecutive patients with prostate cancer (diagnosis code C61 according to ICD-10 classification) who underwent elective RARP from January 2024 to December 2024 at the Department of Urology and Urological Oncology of Pomeranian Medical University in Szczecin.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire)
timeFrame: Preoperatively
Secondary outcomes:
measure: Angle between the pubic bone and the prostate
timeFrame: Preoperatively
measure: Pubic symphysis-prostate apex length (PAL)
timeFrame: Preoperatively
measure: Membranous urethral length (MUL)
timeFrame: Preoperatively
measure: Protrusion of the prostate into the bladder
timeFrame: Preoperatively
measure: Anteroposterior diameter of the pelvic inlet (API)
timeFrame: Preoperatively
measure: Pelvic depth (PD)
timeFrame: Preoperatively
measure: The anteroposterior distance at the midpelvis (APM)
timeFrame: Preoperatively
measure: Pelvic outlet (APO)
timeFrame: Preoperatively
measure: Anteroposterior diameter of the working space during surgery (Workspace AP)
timeFrame: Preoperatively
measure: Transevrse diameter of the working space during surgery (Workspace T)
timeFrame: Preoperatively
Other outcomes:
measure: Erectile function
timeFrame: Preoperatively and in 1 year follow-up after RARP.
measure: Sexual activity
timeFrame: Preoperatively and in 1 year follow-up after RARP.
measure: Lower urinary tract symptoms (LUTS)
timeFrame: Preoperatively
measure: PSA
timeFrame: Preoperatively and in 1 year follow-up after RARP.
measure: Prostate volume
timeFrame: Preoperatively
measure: Suspected prostate cancer on MRI
timeFrame: Preoperatively
measure: Histopatology of prostate cancer
timeFrame: Preoperatively and up to 4 weeks after the surgery.
measure: Clinical stage of prostate cancer
timeFrame: Preoperatively
measure: Weight and height
timeFrame: Preoperatively
measure: Comorbidities
timeFrame: Preoperatively
measure: Medications
timeFrame: Preoperatively
measure: Operative difficulties
timeFrame: Intraoperatively
measure: Postoperative complications
timeFrame: In 90 days follow-up after RARP.
measure: Continence
timeFrame: In 1 year follow-up after RARP.
Locations:
city: Szczecin
country: Poland
facility: Department of Urology and Urological Oncology
Study officials:
References: