Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction

Официальное название

The Impact of Postoperative Bed Rest Duration on the Reconstruction Outcomes of Endoscopic Endonasal Midline Anterior Skull Base Surgery: A Multicenter Randomized Controlled Trial

Обзор

This study is a randomized controlled trial conducted across multiple centers. Due to the anatomical and pathological complexity of endoscopic endonasal skull base surgery, the study scope was restricted to the midline anterior skull base region to maximize homogeneity among enrolled cases. After screening according to inclusion and exclusion criteria and obtaining informed consent, patients were intraoperatively classified into low-flow cerebrospinal fluid (CSF) leak (dural defect ≤1 cm²) or high-flow CSF leak (dural defect \>1 cm²) groups. Patients in the low-flow group were randomly assigned to either a non-bed-rest group or a 2-day bed-rest group, while those in the high-flow group were randomly assigned to either a 1-day or a 3-day bed-rest group. The primary outcome was the reconstruction success rate (from immediately postoperative to 1 month) compared between different bed-rest durations within the low-flow and high-flow subgroups, respectively. Secondary outcomes included the incidence of bed-rest-related postoperative adverse events during hospitalization (safety indicator), postoperative quality-of-life scores (functional indicator), length of postoperative hospital stay (days), and total treatment cost (healthcare resource utilization indicator). By comparing these outcomes across groups, the study aims to evaluate the impact of bed-rest duration on the outcomes of endoscopic endonasal reconstruction of the midline anterior skull base, thereby providing high-quality clinical evidence to facilitate accelerated postoperative recovery.

Вмешательства

• Поведенческое non-bed-rest
  for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively
• Поведенческое 2-day bed-rest
  for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively
• Поведенческое 1-day bed-rest
  for patients with high-flow CSF leak (dural defect \>1 cm²) 1-day bed-rest postoperatively
• Поведенческое 3-day bed-rest
  for patients with high-flow CSF leak (dural defect \>1 cm²) 3-day bed-rest postoperatively

Первичные конечные точки

• Skull base reconstruction success rate [Срок оценки: within 1 month postoperatively]

Вторичные конечные точки (6)

• Postoperative quality-of-life score [Срок оценки: low-flow group: postoperative day 2; high-flow group: postoperative day 4.]
• Incidence of venous thromboembolism [Срок оценки: from postoperative day 1 to 14]
• Incidence of pulmonary infection [Срок оценки: from postoperative day 1 to 14]
• Incidence of pressure ulcers [Срок оценки: from postoperative day 1 to 14]
• Postoperative length of stay [Срок оценки: from postoperative day 1 to 30]
• Postoperative treatment cost [Срок оценки: from postoperative day 1 to 30]

Критерии участия

Критерии включения

• Male and female patients aged 18-75 years.
• Scheduled to undergo endoscopic endonasal midline anterior skull-base surgery with an anticipated risk of intraoperative cerebrospinal fluid leak.
• Pre-operatively alert, with normal limb mobility, able to comply with both post-operative bed-rest and non-bed-rest protocols.
• Absence of severe cardiopulmonary dysfunction or any other comorbidity that would compromise tolerance of general anesthesia or surgical intervention.
• Good patient compliance, voluntary participation in this clinical study, and signed informed consent.

Критерии исключения

• Pre-existing bed-rest-related complications such as hypostatic pneumonia, lower-extremity venous thrombosis, or pressure ulcers.
• Anticipated requirement for prolonged post-operative bed rest.
• No cerebrospinal fluid leakage occurred during surgery, or dural defect extending beyond the midline anterior skull-base region.
• Any other condition that, in the investigator's opinion, renders the participant unsuitable for enrollment.
• Patients with poor treatment compliance.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07465861 · QYFYEC2025-205 · 2025-WJKY173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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