NCT07465861: BRO

Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction

Not yet recruiting NA Last updated 7 April 2026

What this trial tests

NA trial testing non-bed-rest in Skull Base in 316 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	The Affiliated Hospital of Qingdao University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	316
Start date	1 April 2026
Primary completion	31 December 2030
Estimated completion	31 December 2030

Drugs / interventions tested

• non-bed-rest
• 2-day bed-rest
• 1-day bed-rest
• 3-day bed-rest

Conditions studied

• Skull Base — all drugs for Skull Base →

Sponsor

The Affiliated Hospital of Qingdao University

Who can join

Adults 18 to 75, any sex, with Skull Base. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.