Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: non-bed-rest, 2-day bed-rest, 1-day bed-rest, 3-day bed-rest.
- Who it may be relevant to
- Registry conditions: Skull Base. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Postoperative Bed Rest Duration on the Reconstruction Outcomes of Endoscopic Endonasal Midline Anterior Skull Base Surgery: A Multicenter Randomized Controlled Trial
Overview
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
- Behavioral non-bed-rest
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively - Behavioral 2-day bed-rest
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively - Behavioral 1-day bed-rest
for patients with high-flow CSF leak (dural defect \>1 cm²) 1-day bed-rest postoperatively - Behavioral 3-day bed-rest
for patients with high-flow CSF leak (dural defect \>1 cm²) 3-day bed-rest postoperatively
Primary outcome measures
- Skull base reconstruction success rate [Time frame: within 1 month postoperatively]
Secondary outcome measures (6)
- Postoperative quality-of-life score [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 [Time frame: from postoperative day 1 to 30]
- Postoperative treatment cost [Time frame: from postoperative day 1 to 30]
Eligibility criteria
Inclusion criteria
- Male and female patients aged 18-75 years.
- Scheduled to undergo endoscopic endonasal midline anterior skull-base surgery with an anticipated risk of intraoperative cerebrospinal fluid leak.
- Pre-operatively alert, with normal limb mobility, able to comply with both post-operative bed-rest and non-bed-rest protocols.
- Absence of severe cardiopulmonary dysfunction or any other comorbidity that would compromise tolerance of general anesthesia or surgical intervention.
- Good patient compliance, voluntary participation in this clinical study, and signed informed consent.
Exclusion criteria
- Pre-existing bed-rest-related complications such as hypostatic pneumonia, lower-extremity venous thrombosis, or pressure ulcers.
- Anticipated requirement for prolonged post-operative bed rest.
- No cerebrospinal fluid leakage occurred during surgery, or dural defect extending beyond the midline anterior skull-base region.
- Any other condition that, in the investigator's opinion, renders the participant unsuitable for enrollment.
- Patients with poor treatment compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07465861 · QYFYEC2025-205 · 2025-WJKY173