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

NCT06985004 | Active Not Recruiting

• 1 other identifier: KB.006.121.2022/Z-110249
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Robot-Assisted Laparoscopic Radical Prostatectomy

Keywords

Prostate cancer; RARP; robot-assisted radical prostatectomy; preoperative assessment; pelvimetry; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire)

  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.

  Preoperatively

Secondary Outcomes (10)

• 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

Other Outcomes (14)

• Erectile function

  Preoperatively and in 1 year follow-up after RARP.

• Sexual activity

  Preoperatively and in 1 year follow-up after RARP.

• Lower urinary tract symptoms (LUTS)

  Preoperatively

Study Arms (1)

Consecutive patients with prostate cancer who underwent elective RARP

Other: PIODO Questionnaire

Interventions

PIODO Questionnaire OTHER

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.

Consecutive patients with prostate cancer who underwent elective RARP

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with prostate cancer undergoing RARP.

You may not qualify if:

• Neoadjuvant androgen deprivation therapy before RARP.
• Lack of consent for study participation or willingness to comply with all procedures and assessments.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Department of Urology and Urological Oncology

Szczecin, 70-123, Poland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 22, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)