Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter

Официальное название

A Comparative Study of Tubeless Percutaneous Nephrolithotomy With or Without Reverse Ureteral Catheter Insertion

Обзор

Percutaneous nephrolithotomy(PCNL) is a surgical method for upper urinary calculi. The advent of tubeless PCNL (without indwelling nephrostomy tube) has been proved to be safe and effective in reducing postoperative discomfort, shortening hospitalization time and reducing hospitalization costs. Traditional tubeless PCNL usually involves retrograde insertion of the ureteral catheter, which may cause many ureteral related surgical complications. However, there are few reports on tubeless PCNL without reverse ureteral catheter insertion. The goal of this study is to explore the safety and effectiveness of the tubeless PCNL without reverse ureteral catheter insertion.

Подробное описание

This is a key clinical research project of the University of South China (No. USCKF201902K01). The goal of this study is to comparative the safety and clinical efficacy between the tubeless percutaneous nephrolithotomy without reverse insertion of a ureteral catheter and the traditional tubeless percutaneous nephrolithotomy with reverse insertion of a ureteral catheter in the treatment of upper urinary calculi, and to explore the former' applications. It is a prospective, randomized controlled single center study that is conducted for 2 years anticipatively. The clinic physician is responsible for patient recruitment and allocation and the application of computerized random-number generation. For random allocation, participants are given random numbers. Participants with odd numbers are assigned to experimental group, where they undergo tubeless PCNL without reverse insertion of a ureteral catheter. Participants with even numbers are assigned to control group and undergo tubeless PCNL with reverse insertion of a ureteral catheter. The doctors managing the operations accept participants and execute the surgical treatments. All participants sign clinical-trial informed consent and surgical informed consent during the preoperative conversation. Follow-up observation is conducted for 1 month after surgery. After completion of the study, we collect relevant clinical data from the participants. The primary and secondary outcomes are analyzed and compared between the two groups.

Вмешательства

• Процедура Without reverse insertion of a ureteral catheter
  Traditional tubeless percutaneous nephrolithotomy usually need retrograde ureteral catheter insertion. Our intervention is that the tubeless percutaneous nephrolithotomy is executed without reverse insertion of a ureteral catheter.

Первичные конечные точки

• Changes of inflammatory indicators after surgery [Срок оценки: Hour 3 after the surgery]
• Changes in renal bleeding after surgery [Срок оценки: Hour 3 after the surgery]
• Changes of renal-function after surgery [Срок оценки: Hour 3 after the surgery]
• Pain score after surgery [Срок оценки: Hour 3 after the surgery]
• Incidence of pneumothorax and hydrothorax [Срок оценки: Day 2 after the surgery]
• Incidence of ureteral stone street [Срок оценки: Day 2 after the surgery]

Вторичные конечные точки (4)

• Duration of operation [Срок оценки: during the procedure]
• Duration of hospital stay [Срок оценки: immediately after the discharge]
• Hospital costs [Срок оценки: immediately after the discharge]
• Stone-free rates [Срок оценки: Day 2 after the surgery]

Критерии участия

Критерии включения

• Participants who met the the applications of PCNL surgery in the 2019 Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases
• Participants who agree to undergo tubeless PCNL
• The participants' maximum diameter of the stone should be less than 3.5cm

Критерии исключения

• Confirmation by computerized tomography (CT) images and blood biochemical indicators of infectious stones or complex staghorn stones
• Obvious surgical contraindications, such as severe heart and lung insufficiency, abnormal coagulatory function
• Previous PCNL or nephrolithotomy, presence of an indwelling ureteral stent or nephrostomy tube before surgery
• Renal trauma or congenital malformation of the urinary system

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of University of South China — Hengyang

Идентификаторы

NCT: NCT05574517 · USCKF201902K01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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