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A Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Domestically Produced Nasal Mucosal Protective Sleeve in Neuroendoscopic Craniomaxillofacial Surgery

A Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Domestically Produced Nasal Mucosal Protective Sleeve in Neuroendoscopic Craniomaxillofacial Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113337
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Experimental group:The experimental group used a domestically produced nasal mucosa protective cover sleeve. After completing nasal disinfection, the nasal mucosa protective sleeve was placed into the
Control group:The control group did not use domestic nasal mucosa protective sleeves

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years and <75 years; 2. Diseases requiring transnasal endoscopic neurosurgery (pituitary tumors, craniopharyngiomas, chordomas, tuberculum sellae meningiomas, etc.); 3. Patients who agree to participate in this trial and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe coagulation disorders and other surgical contraindications; 2. Refusal to undergo surgery; 3. On the day of surgery, being menstruating, pregnant, or breastfeeding; 4. Oral anticoagulant or antiplatelet drug use within the past month; 5. Conditions deemed unsuitable for surgery after evaluation by a clinician; 6. History of allergy to latex materials.

Design outcomes

Primary

MeasureTime frame
Postoperative nasal function (SNOT-22 score);

Secondary

MeasureTime frame
Average length of hospital stay after surgery;Surgery cost;Hospital stay;Blood loss;operative time;patient safety;Domestic nasal mucosa protective sleeve safety of use;

Countries

China

Contacts

Public ContactSongbai Gui

Beijing Tiantan Hospital, Capital Medical University

guisongbai@yeah.net+86 130 5111 8879

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026