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A pilot randomized controlled trial on the application of a novel suction bipolar electrocautery device in functional endoscopic sinus surgery for the treatment of chronic rhinosinusitis

Evaluation of the Hemostatic Efficacy and Safety of Suction Bipolar Electrocautery in Endoscopic Sinus Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108657
Enrollment
Unknown
Registered
2025-09-03
Start date
2023-12-13
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Chronic rhinosinusitis

Interventions

Test group:Patients in the experimental group will undergo functional endoscopic sinus surgery using a novel suction bipolar electrocautery device for intraoperative hemostasis.
Control group:Patients in the control group will undergo functional endoscopic sinus surgery using a suction monopolar electrocautery for intraoperative hemostasis.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 75 years; (2) Diagnosed with chronic rhinosinusitis (CRS), with or without nasal polyps, in accordance with the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS 2020); (3) Scheduled for primary functional endoscopic sinus surgery (FESS); (4) Preoperative Lund-Mackay score >=5 on sinus CT; (5) Normal coagulation function (platelet count, PT, and APTT within reference ranges or clinically acceptable); (6) Provided written informed consent after fully understanding the study protocol; (7) No participation in other clinical trials within the past three months.

Exclusion criteria

Exclusion criteria: (1) known contraindications to general anesthesia or nasal endoscopic surgery; (2) long-term use of anticoagulants or other medications affecting coagulation; (3) long-term systemic corticosteroid therapy; (4) major systemic diseases, including immunodeficiency (e.g., HIV infection or long-term immunosuppressant use), uncontrolled hypertension (>=160/100 mmHg despite >=3 medications), uncontrolled diabetes (HbA1c > 9%), or active pulmonary tuberculosis; (5) nasal drug-eluting stent placement within the past 3 months; (6) prior nasal surgeries (e.g., septoplasty, sinus surgery, turbinate surgery); (7) pregnancy, lactation, or other physiological conditions likely to affect outcomes; (8) pre-existing ocular structural diseases (e.g., glaucoma, optic atrophy, high refractive error) or history of eye surgery.

Design outcomes

Primary

MeasureTime frame
Sinonasal ventilation status: Lund-Kennedy score;Symptom improvement: Sino-Nasal Outcome Test-20 (SNOT-20);

Secondary

MeasureTime frame
Recurrence rate of nasal polyps;Postoperative complications;

Countries

China

Contacts

Public ContactLiu Feng

West China Hospital, Sichuan University

alexliufeng@vip.163.com+86 189 8060 6340

Outcome results

None listed

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