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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-WJKY173 | Other Grant/Funding Number | Medical and Health Scientific Research Project of Qingdao |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-flow / non-bed-rest group | Experimental |
| |
| Low-flow / 2-day bed-rest group | Active Comparator |
| |
| High-flow / 1-day bed-rest group | Experimental |
| |
| High-flow / 3-day bed-rest group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-bed-rest | Behavioral | for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skull base reconstruction success rate | within 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative quality-of-life score | quality-of-life score is measured by Postoperative Recovery Scale for Adult (total score: 0-1000; higher is better) | low-flow group: postoperative day 2; high-flow group: postoperative day 4. |
| Incidence of venous thromboembolism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Jiang | Contact | +86 13256875886 | jiangyanoto@qdu.edu.cn | |
| Xudong Yan | Contact | +86 18661805302 | yanxudong@qdu.edu.cn |
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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.
The data will become available 6 months after the publication of the primary results and will be accessible for 5 years thereafter.
Data will be shared with researchers who provide a methodologically sound proposal that has been approved by the study's data access committee. Approved users must sign a data use agreement, committing to using the data only for the approved purpose, not attempting to re-identify participants, and securing the data appropriately. Requests for data access can be directed to the corresponding author.
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| ID | Term |
|---|---|
| D002559 | Cerebrospinal Fluid Rhinorrhea |
| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D001510 | Bed Rest |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 2-day bed-rest | Behavioral | for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively |
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| 1-day bed-rest | Behavioral | for patients with high-flow CSF leak (dural defect >1 cm²) 1-day bed-rest postoperatively |
|
| 3-day bed-rest | Behavioral | for patients with high-flow CSF leak (dural defect >1 cm²) 3-day bed-rest postoperatively |
|
| 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 | stay duration in days | from postoperative day 1 to 30 |
| Postoperative treatment cost | from postoperative day 1 to 30 |
| D020196 | Trauma, Nervous System |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086722 | Rhinorrhea |
| D012818 | Signs and Symptoms, Respiratory |
| D014947 | Wounds and Injuries |