Predicting Operational Difficulties and Outcomes of RARP Based on Preoperative Assessment - Introducing the PIODO Questionnaire

Pomeranian Medical University Szczecin

Status: Active, not recruiting

Conditions: Prostate Cancer; Robot-Assisted Laparoscopic Radical Prostatectomy

Treatments: Other: PIODO Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06985004

KB.006.121.2022/Z-110249

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

288 participants in 1 patient group

Consecutive patients with prostate cancer who underwent elective RARP

Treatment:

Other: PIODO Questionnaire