Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction (BRO)

April 1, 2026 updated by: The Affiliated Hospital of Qingdao University

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-flow / non-bed-rest group
Behavioral: non-bed-rest
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively
Active Comparator: Low-flow / 2-day bed-rest group
Behavioral: 2-day bed-rest
for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively
Experimental: High-flow / 1-day bed-rest group
Behavioral: 1-day bed-rest
for patients with high-flow CSF leak (dural defect >1 cm²) 1-day bed-rest postoperatively
Active Comparator: High-flow / 3-day bed-rest group
Behavioral: 3-day bed-rest
for patients with high-flow CSF leak (dural defect >1 cm²) 3-day bed-rest postoperatively

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Skull base reconstruction success rate
Time Frame: within 1 month postoperatively
within 1 month postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative quality-of-life score
Time Frame: 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)
low-flow group: postoperative day 2; high-flow group: postoperative day 4.
Incidence of venous thromboembolism
Time Frame: from postoperative day 1 to 14
from postoperative day 1 to 14
Incidence of pulmonary infection
Time Frame: from postoperative day 1 to 14
from postoperative day 1 to 14
Incidence of pressure ulcers
Time Frame: from postoperative day 1 to 14
from postoperative day 1 to 14
Postoperative length of stay
Time Frame: from postoperative day 1 to 30
stay duration in days
from postoperative day 1 to 30
Postoperative treatment cost
Time Frame: from postoperative day 1 to 30
from postoperative day 1 to 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QYFYEC2025-205
  • 2025-WJKY173 (Other Grant/Funding Number: Medical and Health Scientific Research Project of Qingdao)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will become available 6 months after the publication of the primary results and will be accessible for 5 years thereafter.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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