Clinical trial · Observational
Predicting Operational Difficulties and Outcomes of RARP Based on Preoperative Assessment - Introducing the PIODO Questionnaire
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Robot-Assisted Laparoscopic Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIODO Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Consecutive patients with prostate cancer who underwent elective RARP
- interventionNames
- Other: PIODO Questionnaire
Primary outcomes (1)
- measure
- Preoperative Index for Operative Difficulties and Outcomes (PIODO Questionnaire)
- timeFrame
- Preoperatively
- description
- 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 (10)
- measure
- Angle between the pubic bone and the prostate
- timeFrame
- Preoperatively
- description
- The angle between the pros¬tatic urethra and the posterior side of the pubic bone. Measured in degrees on MRI T2-weighted images.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available