Bed Rest Duration and Outcomes in Endoscopic Skull Base Reconstruction

ConditionSkull Base
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

316 Participants
are divided into 4 treatment groups
Group A: Low-flow / non-bed-rest groupExperimental treatment 1 intervention
Group B: Low-flow / 2-day bed-rest groupActive comparator 1 intervention
Group C: High-flow / 1-day bed-rest groupExperimental treatment 1 intervention
Group D: High-flow / 3-day bed-rest groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Skull base reconstruction success rate

Time frame
within 1 month postoperatively

Secondary outcomes

1

Postoperative quality-of-life score

quality-of-life score is measured by Postoperative Recovery Scale for Adult (total score: 0-1000; higher is better)

Time frame
low-flow group: postoperative day 2; high-flow group: postoperative day 4.
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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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