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NCT Number: NCT07465861

Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-bed-rest

Behavioral

for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) non-bed-rest postoperatively

2-day bed-rest

Behavioral

for patients with low-flow cerebrospinal fluid leak (dural defect ≤1 cm²) 2-day bed-rest postoperatively

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

Primary outcomes

  1. Skull base reconstruction success rate

    Time frame: within 1 month postoperatively

Secondary outcomes

  1. 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)

  2. Incidence of venous thromboembolism

    Time frame: from postoperative day 1 to 14

  3. Incidence of pulmonary infection

    Time frame: from postoperative day 1 to 14

  4. Incidence of pressure ulcers

    Time frame: from postoperative day 1 to 14

  5. Postoperative length of stay

    Time frame: from postoperative day 1 to 30

    stay duration in days

  6. Postoperative treatment cost

    Time frame: from postoperative day 1 to 30

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study 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

Acronym: BRO

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 12, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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