Supine vs. Prone PCNL for Large Renal Stones: A Randomized Trial in Yemen.

Официальное название

Comparative Evaluation of Early Postoperative Complications, Cost-Effectiveness, and Patient-Centered Outcomes Following Supine and Prone Standard Percutaneous Nephrolithotomy (PCNL): A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare the safety, cost-effectiveness, and patient recovery of two different surgical positions for percutaneous nephrolithotomy (PCNL) in adults aged 18 to 70 years who have kidney stones larger than 2 cm. The main questions it aims to answer are: * Does the supine (lying on the back) surgical position result in fewer early postoperative complications than the traditional prone (lying on the stomach) position? * Does the supine position reduce the total surgery time, direct hospital costs, and postoperative pain? Researchers will compare patients assigned to undergo PCNL in the supine position to those assigned to the prone position to see if the supine approach offers a safer, more cost-effective, and more comfortable recovery. Participants will: * Undergo standard PCNL surgery to remove their kidney stones in either the supine or prone position. * Have their pain levels, surgery time, and any early surgical complications monitored during their hospital stay. * Complete brief questionnaires regarding their overall surgical satisfaction and quality of life at 1 month and 3 months after the procedure.

Вмешательства

• Процедура Supine Percutaneous Nephrolithotomy (PCNL)
  Standard PCNL performed with the patient in the supine position using a standard 24-30 Fr tract.
• Процедура Prone Percutaneous Nephrolithotomy (PCNL)
  Standard PCNL performed with the patient in the traditional prone position using a standard 24-30 Fr tract.

Первичные конечные точки

• Incidence and Severity of Early Postoperative Complications [Срок оценки: Up to 30 days post-surgery]

Вторичные конечные точки (5)

• Total Operative Time [Срок оценки: Intraoperative (Day 0)]
• Postoperative Pain Score [Срок оценки: At 6 hours, 12 hours, and 24 hours post-surgery]
• Health-Related Quality of Life (HRQoL) [Срок оценки: At 1 month and 3 months post-surgery]
• Patient Satisfaction Score [Срок оценки: At 30 days post-surgery]
• Direct Hospitalization Costs [Срок оценки: From hospital admission to hospital discharge (typically 1 to 7 days)]

Критерии участия

Критерии включения

• Patients aged 18-70 years.
• Diagnosis of solitary or multiple renal stones with a cumulative diameter greater than 2 cm, confirmed by imaging (CT KUB).
• Patients eligible for standard PCNL (24-30 Fr).
• American Society of Anesthesiologists (ASA) physical status I-III.
• Willingness and ability to provide informed consent.

Критерии исключения

• Patients with active urinary tract infection (UTI) not responding to antibiotics.
• Patients with bleeding diathesis or on anticoagulant therapy that cannot be safely discontinued.
• Patients with anatomical abnormalities of the kidney or urinary tract that preclude standard PCNL.
• Pregnant women.
• Patients with severe cardiopulmonary disease where general anesthesia or prolonged surgical positioning is contraindicated.
• Patients with a history of previous ipsilateral renal surgery.
• Patients unwilling or unable to comply with follow-up protocols.

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

Yemen · 1 центр

• Al-Kuwait University Hospital — Sanaa

Идентификаторы

NCT: NCT07627503 · PCNL-SANA-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗