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Идёт набор NCT06397287

PROM Project Urology

— Наблюдательное Surgery Urologic Diseases Urologic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observation of patients undergoing sugery.
Кому может быть актуально
Состояния в реестре: Surgery, Urologic Diseases, Urologic Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Standardized Collection of Patient Reported Outcomes (PROs) in Everyday Clinical Practice

Обзор

All patients undergoing urological surgery or treatment should receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. Indication-specific, individual pathways are set up, for example, for patients with localized prostate cancer, benign prostate enlargement, bladder dysfunction or erectile dysfunction. In combination with the clinical data, the PROM data should help to improve the quality of the results and, if necessary, adapt treatment pathways to patient needs.

Вмешательства

  • Другое Observation of patients undergoing sugery
    All patients undergoing urological surgery or treatment receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. Indication-specific, individual pathways are set up,

Первичные конечные точки

  • Change in functional treatment outcome in patients with prostate cancer, assessed by EPIC-26: (Expanded Prostate cancer Index Composite) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in health-related quality of life (PROMIS-10: Patient-Reported Outcomes Measurement Information System) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in pain: Brief Pain Inventory (BPI) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in erectile function (IIEF: International Index of Erectile Function) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in bladder function/micturition (IPSS: International Prostate Symptom Score) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in bladder function/micturition (OAB-SF: Overactive Bladder Questionnaire, short form) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in bladder function/micturition (ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in pelvic pain (NHS-CPSI: Chronic prostatits symptom index) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
Вторичные конечные точки (8)
  • patient characteristics: age [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • patient characteristics:comorbidities [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • patient characteristics: medication (name, type, dose, interval) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • patient characteristics: disease-specific data (tumor histology, oncologic status) [Срок оценки: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Perioperative data: duration of sugery (minutes) [Срок оценки: during surgery, surgery time depending on the disease (30 minutes to 4 hours)]
  • Perioperative data: blood loss (ml) [Срок оценки: during surgery, surgery time depending on the disease (30 minutes to 4 hours)]
  • Perioperative data: transfusion (ml [Срок оценки: during surgery, surgery time depending on the disease (30 minutes to 4 hours)]
  • Perioperative data: length of hospital stay (days) [Срок оценки: depending on the disease and following surgery (1 to 10 days)]

Критерии участия

Критерии включения

  • Patients treated at the Department of Urology
  • ≥18 years of age
  • Active Mail-account, use of smartphone/tablet/PC
  • Written informed consent

Критерии исключения

\- Patients who cannot give written consent and/or do not have digital competence (e.g. no active e-mail account)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австрия · 1 центр
  • Röthl Martina Anna — Graz

Идентификаторы

NCT: NCT06397287 · 35-405 ex 22/23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗