Skull Base
Conditions
Keywords
Bed rest, Endoscopic surgery, Cerebrospinal fluid rhinorrhea
Brief summary
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.
Interventions
BEHAVIORALnon-bed-rest
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively
BEHAVIORAL2-day bed-rest
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively
BEHAVIORAL1-day bed-rest
for patients with high-flow CSF leak (dural defect \>1 cm²) 1-day bed-rest postoperatively
BEHAVIORAL3-day bed-rest
for patients with high-flow CSF leak (dural defect \>1 cm²) 3-day bed-rest postoperatively
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female patients aged 18-75 years. 2. Scheduled to undergo endoscopic endonasal midline anterior skull-base surgery with an anticipated risk of intraoperative cerebrospinal fluid leak. 3. Pre-operatively alert, with normal limb mobility, able to comply with both post-operative bed-rest and non-bed-rest protocols. 4. Absence of severe cardiopulmonary dysfunction or any other comorbidity that would compromise tolerance of general anesthesia or surgical intervention. 5. Good patient compliance, voluntary participation in this clinical study, and signed informed consent.
Exclusion criteria
1. Pre-existing bed-rest-related complications such as hypostatic pneumonia, lower-extremity venous thrombosis, or pressure ulcers. 2. Anticipated requirement for prolonged post-operative bed rest. 3. No cerebrospinal fluid leakage occurred during surgery, or dural defect extending beyond the midline anterior skull-base region. 4. Any other condition that, in the investigator's opinion, renders the participant unsuitable for enrollment. 5. Patients with poor treatment compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skull base reconstruction success rate | within 1 month postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative quality-of-life score | low-flow group: postoperative day 2; high-flow group: postoperative day 4. | quality-of-life score is measured by Postoperative Recovery Scale for Adult (total score: 0-1000; higher is better) |
| Incidence of venous thromboembolism | from postoperative day 1 to 14 | — |
| Incidence of pulmonary infection | from postoperative day 1 to 14 | — |
| Incidence of pressure ulcers | from postoperative day 1 to 14 | — |
| Postoperative length of stay | from postoperative day 1 to 30 | stay duration in days |
| Postoperative treatment cost | from postoperative day 1 to 30 | — |
Contacts
CONTACTYan Jiang
CONTACTXudong Yan
Outcome results
None listed