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Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction

Study acronym: BRO
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Feb 9, 2026 to Apr 1, 2026v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07465861
Lead Sponsor The Affiliated Hospital of Qingdao University
Conditions
(from sponsor)
Skull Base
Related terms Cerebrospinal Fluid Rhinorrhea
Enrollment 316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov