Skull BaseBRONCT07465861
Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction
A study testing non-bed-rest, 2-day bed-rest and 1-day bed-rest in people with Skull Base, run by The Affiliated Hospital of Qingdao University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Skull Base
- What is being tested?
- non-bed-rest, 2-day bed-rest and 1-day bed-rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Conditions
- Skull Base
- Being tested
- non-bed-rest, 2-day bed-rest, 1-day bed-rest, 3-day bed-rest
- Keywords
- Bed rest, Endoscopic surgery, Cerebrospinal fluid rhinorrhea
- Medical subject headings
- Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-bed-restBehavioural
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively
2-day bed-restBehavioural
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively
1-day bed-restBehavioural
for patients with high-flow CSF leak (dural defect >1 cm²) 1-day bed-rest postoperatively
3-day bed-restBehavioural
for patients with high-flow CSF leak (dural defect >1 cm²) 3-day bed-rest postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Low-flow / non-bed-rest group | Experimental | Not described Receives: Behavioral: non-bed-rest |
| Low-flow / 2-day bed-rest group | Active comparator | Not described Receives: Behavioral: 2-day bed-rest |
| High-flow / 1-day bed-rest group | Experimental | Not described Receives: Behavioral: 1-day bed-rest |
| High-flow / 3-day bed-rest group | Active comparator | Not described Receives: Behavioral: 3-day bed-rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skull base reconstruction success rate
Measured: within 1 month postoperatively
Secondary outcomes (6)
Postoperative quality-of-life score
quality-of-life score is measured by Postoperative Recovery Scale for Adult (total score: 0-1000; higher is better)
Measured: low-flow group: postoperative day 2; high-flow group: postoperative day 4.
Incidence of venous thromboembolism
Measured: from postoperative day 1 to 14
Incidence of pulmonary infection
Measured: from postoperative day 1 to 14
Incidence of pressure ulcers
Measured: from postoperative day 1 to 14
Postoperative length of stay
stay duration in days
Measured: from postoperative day 1 to 30
Postoperative treatment cost
Measured: from postoperative day 1 to 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull BaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465861
- Sponsor's protocol ID
- QYFYEC2025-205
- Other IDs
- 2025-WJKY173
- Acronym
- BRO
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07465861
- Acronym / sponsor ID
- BRO / QYFYEC2025-205
- Conditions
- Skull Base
- Keywords
- Bed rest, Endoscopic surgery, Cerebrospinal fluid rhinorrhea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-flow / non-bed-rest group | Experimental | Behavioral: non-bed-rest |
| Low-flow / 2-day bed-rest group | Active comparator | Behavioral: 2-day bed-rest |
| High-flow / 1-day bed-rest group | Experimental | Behavioral: 1-day bed-rest |
| High-flow / 3-day bed-rest group | Active comparator | Behavioral: 3-day bed-rest |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-bed-restfor patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively | Behavioural | Low-flow / non-bed-rest group |
| 2-day bed-restfor patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively | Behavioural | Low-flow / 2-day bed-rest group |
| 1-day bed-restfor patients with high-flow CSF leak (dural defect >1 cm²) 1-day bed-rest postoperatively | Behavioural | High-flow / 1-day bed-rest group |
| 3-day bed-restfor patients with high-flow CSF leak (dural defect >1 cm²) 3-day bed-rest postoperatively | Behavioural | High-flow / 3-day bed-rest group |
Primary outcome
Skull base reconstruction success rate
Time frame: within 1 month postoperatively
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing non-bed-rest, 2-day bed-rest and 1-day bed-rest in people with Skull Base, run by The Affiliated Hospital of Qingdao University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Jiang (+86 13256875886, jiangyanoto@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skull base reconstruction success rate (time frame: within 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.