An interventional study of non-bed-rest and 2-day bed-rest in Skull Base, sponsored by The Affiliated Hospital of Qingdao University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Treatment
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.
The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: non-bed-rest
Behavioral: 2-day bed-rest
Behavioral: 1-day bed-rest
Behavioral: 3-day bed-rest
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively
for patients with high-flow CSF leak (dural defect \>1 cm²) 1-day bed-rest postoperatively
for patients with high-flow CSF leak (dural defect \>1 cm²) 3-day bed-rest postoperatively
Skull base reconstruction success rate
Time frame: within 1 month postoperatively
Postoperative quality-of-life score
quality-of-life score is measured by Postoperative Recovery Scale for Adult (total score: 0-1000; higher is better)
Time frame: low-flow group: postoperative day 2; high-flow group: postoperative day 4.
Incidence of venous thromboembolism
Time frame: from postoperative day 1 to 14
Incidence of pulmonary infection
Time frame: from postoperative day 1 to 14
Incidence of pressure ulcers
Time frame: from postoperative day 1 to 14
Postoperative length of stay
stay duration in days
Time frame: from postoperative day 1 to 30
Postoperative treatment cost
Time frame: from postoperative day 1 to 30
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the primary and secondary publications of this trial will be shared. This includes baseline demographics, surgical details, perioperative variables, outcomes data (e.g., reconstruction success, complication rates), and follow-up assessments.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Cerebrospinal Fluid Rhinorrhea
The Affiliated Hospital of Qingdao University