Predicting Operational Difficulties and Outcomes of RARP Based on Preoperative Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostate Cancer Robot-Assisted Laparoscopic Radical Prostatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consecutive patients with prostate cancer who underwent elective RARP

PIODO Questionnaire

Intervention Type 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.

Interventions

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PIODO Questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No