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NCT07907393
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Conditions: Nasal Polyps
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: Lahore General Hospital
Location: Lahore General Hospital, Lahore Lahore Punjab Province
Summary
This study compared two surgical techniques for patients with nasal polyps affecting both sides of the nose and sinuses. Nasal polyps were soft swellings that caused symptoms such as nasal blockage, nasal discharge, and reduced sense of smell. The study assessed whether the amount of blood lost during surgery and the time required to complete surgery differed between microdebrider-assisted and conventional functional endoscopic sinus surgery.
The randomized controlled study was conducted in the Department of Ear, Nose and Throat at Lahore General Hospital, Lahore, over six months. It included 56 patients aged 18-70 years whose symptoms had persisted despite at least eight weeks of medical treatment. Patients were randomly assigned to two groups of 28 using sealed envelopes. Both groups underwent surgery under general anesthesia. In the microdebrider-assisted group, a powered instrument that cut and suctioned tissue simultaneously was used to remove the polyps. In the conventional group, standard surgical instruments, including forceps and curettes, were used.
Blood loss was measured in milliliters using the fluid collected through suction, after subtracting irrigation fluid, and the change in surgical sponge weights. Operative duration was recorded in minutes. These measurements were compared between the two groups. The study hypothesis was that microdebrider-assisted and conventional surgery differed in intraoperative blood loss and operative duration.
Eligibility Criteria
Inclusion Criteria:
* Adult patients aged 18-70 years diagnosed with bilateral sinonasal polyposis requiring surgical intervention.
* Patients with persistent symptoms such as nasal obstruction, anosmia, or rhinorrhea despite at least 8 weeks of optimized medical management, including systemic and intranasal steroids.
* CT scan showing Lund-Mackay scores ≥8 on each side.
Exclusion Criteria:
* Patients with a history of previous sinus or nasal surgeries.
* Cases with unilateral nasal polyposis or sinonasal tumors.
* Patients with bleeding disorders, on antiplatelet therapy, or with active sinonasal infections.
* Patients presenting with nasal polyposis secondary to fungal sinusitis, chronic granulomatous disease, or cystic fibrosis.
* Pregnant or lactating women due to surgical and anesthetic risks.
* Patients with ASA class 4-6.
* Patients requiring simultaneous additional surgeries, such as septoplasty or turbinate reduction, to avoid confounding factors.
Source: ClinicalTrials.gov (NCT07907393). StuddyBuddy aggregates publicly available trial information.