Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS
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: ClearPETRA suction access sheath, ClearPETRA suction access sheath.
- Кому может быть актуально
- Состояния в реестре: Kidney Stones, Nephrolithiasis, Urolithiasis. 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
- США
- 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
Comparing Efficiency and Stone-Free Rates After Mini-Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Access Sheaths
Обзор
The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.
Подробное описание
With the advent of mini-PCNLs, some endourologists have been utilizing the technique to treat renal calculi up to 3cm in size with better stone free rates and similar comorbidity compared to ureteroscopy. These procedures require percutaneous renal access, and it is associated with greater length of stay and fluoroscopy time.
The ClearPETRA ureteral access sheath has shown great promise with improving stone free rates, decreasing intra-renal pressure and delivering some of the benefits of mini-PCNL without the added risk associated with obtaining percutaneous renal access.
The ClearPETRA flexible suction ureteral access sheath anecdotally improves efficiency and allows endourologists to better clear stone debris when compared to traditional ureteral access sheaths. We have yet to see a comparison between suction ureteral access sheaths and mini-PCNL with the suction renal access sheath.
Study Hypothesis: Compared to traditional access sheaths, using ClearPETRA access sheaths will result in an improvement in stone free rates with both modalities, with lower complications. Using ClearPETRA access sheaths in both modalities compared to traditional access sheaths should result in less of a difference in stone free rates between the ureteroscopy group and the mini-PCNL group.
Вмешательства
- Устройство ClearPETRA suction access sheath
Ureteroscopy utilizing the ClearPETRA suction access sheath. - Устройство ClearPETRA suction access sheath
Mini-PCNL utilizing the ClearPETRA suction access sheath
Первичные конечные точки
- Stone free rate [Срок оценки: 4 weeks post-procedure]
Вторичные конечные точки (9)
- Surgery time [Срок оценки: Procedure day (1 day)]
- Complication rate [Срок оценки: Procedure day (1 day)]
- Unplanned hospital visits [Срок оценки: 90 days postoperatively]
- Need for additional procedure [Срок оценки: 90 days postoperatively]
- Length of stay [Срок оценки: Perioperatively (starting at Baseline/Procedure Date)]
- Inability to access ureter [Срок оценки: Procedure day (1 day)]
- Need to upsize from 18Fr Sheath [Срок оценки: Procedure day (1 day)]
- Occurrence of post-procedure sepsis [Срок оценки: Perioperatively (starting at Baseline/Procedure Date)]
- Hospital / patient costs (in total for procedure and any necessary postoperative hospital admissions or procedures related to the initial procedure). [Срок оценки: Perioperatively (starting at Baseline/Procedure Date)]
Критерии участия
Критерии включения
- Patients 18 years or older
- Have a CT scan showing renal stones 1-3cm in length
- Patients who will be able to read, understand, and complete patient questionnaires
Критерии исключения
- Pregnant individuals
- Those with anomalous renal anatomy
- Patients with a urinary diversion (ex: Ileal conduit, reservoir, bladder substitute, etc.)
- Any condition rendering patient medically unfit to undergo either procedure (Bleeding diasthesis)
- Patients who lack decisional capacity
- Patients who are non-english speakers\*
- Non-recruitment of non-english speakers is due to the study being a small pilot study that is used to assess the stone free rate for patients treated with a ureteroscopy or mini-PCNL using ClearPETRA suction access sheaths in a small portion of our patient population seeking treatment for stones. The team also does not possess the bandwidth or personnel to consent patients who are non-English speaking.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Northwestern Memorial Hospital — Chicago
Идентификаторы
NCT: NCT07072598 · STU00222993