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NCT Number: NCT06985004

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Angle between the pubic bone and the prostate

    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.

  2. Pubic symphysis-prostate apex length (PAL)

    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.

  3. Membranous urethral length (MUL)

    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.

  4. Protrusion of the prostate into the bladder

    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.

  5. Anteroposterior diameter of the pelvic inlet (API)

    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.

  6. Pelvic depth (PD)

    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.

  7. The anteroposterior distance at the midpelvis (APM)

    Time frame: Preoperatively

    Diameter from the inferior aspect of the pubic symphysis to the sacrococcygeal junction. Measured in centimeters on MRI T2-weighted images.

  8. Pelvic outlet (APO)

    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.

  9. Anteroposterior diameter of the working space during surgery (Workspace AP)

    Time frame: Preoperatively

    Diameter from anterior peritoneum to anterior border of coccyx (inner border). Measured in centimeters on MRI T2-weighted images.

  10. Transevrse diameter of the working space during surgery (Workspace T)

    Time frame: Preoperatively

    Diameter between medial border of acetabulum. Measured in centimeters on MRI T2-weighted images.

Other outcomes

  1. Erectile function

    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.

  2. Sexual activity

    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.

  3. Lower urinary tract symptoms (LUTS)

    Time frame: Preoperatively

    Presence of LUTS marked as 1, lack of symptoms marked as 0.

  4. PSA

    Time frame: Preoperatively and in 1 year follow-up after RARP.

    Prostate-specific antigen (PSA) serum level.

  5. Prostate volume

    Time frame: Preoperatively

    Prostate volume based on the MRI scan in milliliters.

  6. Suspected prostate cancer on MRI

    Time frame: Preoperatively

    Measured using Prostate Imaging Reporting and Data System (PI-RADS) assessment categories.

  7. Histopatology of prostate cancer

    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.

  8. Clinical stage of prostate cancer

    Time frame: Preoperatively

    Stage based on digital rectal examination (DRE) only in accordance with the EAU guidelines.

  9. Weight and height

    Time frame: Preoperatively

    Weight and height will be combined to report body mass index (BMI) in kg/m^2

  10. Comorbidities

    Time frame: Preoperatively

    List of patients comorbidities.

  11. Medications

    Time frame: Preoperatively

    Medications that can affect continence and/or erectile function - 1 if used, 0 if not.

  12. Operative difficulties

    Time frame: Intraoperatively

    Operative difficulties were defined as:

    • Operative time of 3 hours or longer.
    • Blood loss over 500 ml.
    • Need for blood transfusion during surgery.
    • Lack of nerve-sparing unrelated to high-risk carcinoma.
    • Presence of intraoperative complications reported by the surgeon. Presence of operative difficulties marked as 1, lack of difficulties as 0.
  13. Postoperative complications

    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.

  14. Continence

    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.

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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