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

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: Not yet recruiting
• Conditions: Skull Base
• Intervention / Treatment: Behavioral: non-bed-rest; Behavioral: 2-day bed-rest; Behavioral: 1-day bed-rest; Behavioral: 3-day bed-rest

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Jiang; Phone Number: +86 13256875886; Email: jiangyanoto@qdu.edu.cn
• Study Contact Backup: Name: Xudong Yan; Phone Number: +86 18661805302; Email: yanxudong@qdu.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Skull base reconstruction success rate	within 1 month postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative quality-of-life score	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		from postoperative day 1 to 14
Incidence of pulmonary infection		from postoperative day 1 to 14
Incidence of pressure ulcers		from postoperative day 1 to 14
Postoperative length of stay	stay duration in days	from postoperative day 1 to 30
Postoperative treatment cost		from postoperative day 1 to 30

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 3, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopic surgery; Bed rest; Cerebrospinal fluid rhinorrhea
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Wounds and Injuries; Signs and Symptoms, Respiratory; Craniocerebral Trauma; Trauma, Nervous System; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebrospinal Fluid Leak; Rhinorrhea; Cerebrospinal Fluid Rhinorrhea; Therapeutics; Bed Rest
• Other Study ID 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