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Published on: June 20, 2018
Efficacy of Full and Limited Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Nasal Polyps: A Randomised
P Virkkula1, S Hammarén-Malmi1, A Laulajainen-Hongisto1
1Department of Otorhinolaryngology-Head and Neck Surgery, Helsinki University Hospital, and University of Helsinki, Helsinki, Finland.
Background:
Despite adequate local treatment, chronic rhinosinusitis with nasal polyps (CRSwNP) may remain uncontrolled and necessitate endoscopic sinus surgery (ESS). It remains unclear what extent of ESS is most effective. This trial compares two common surgical approaches: full and limited functional ESS (FESS) in patients with CRSwNP.
Methods:
AirGOs Operative is a randomised, controlled trial performed in two university hospitals. Patients with a total Sino-nasal-outcome-test (SNOT-22) score ≥ 30, bilateral nasal polyp score ≥ 4, modified Lund-Mackay radiological score ≥ 14, and previous surgery or systemic medication for CRSwNP were included. The primary outcome measure was the change in disease-specific health-related quality of life measure SNOT-22 between the baseline and 12- and 24-month follow-ups.
Findings:
Between Oct 23, 2018 and Oct 12, 2022, 97 patients were recruited. The per protocol analysis included 47 patients in the full FESS group and 47 patients in the limited FESS group. At 12 months, the mean SNOT-22 score was 22.3 (SD 15.7) in the full FESS group and 31.5 (SD 18.8) in the limited FESS group yielding a mean difference of -9.2. At 24 months, the mean SNOT-22 scores were 25.3 (SD 16.9) and 27.8 (SD 21.6), respectively, with a mean difference of -2.5. However, the difference in change of total SNOT-22 scores between the groups was insignificant and did not exceed the minimal clinically important difference. Several secondary outcome measures, amongst which olfaction and polyp load, showed differences in improvement between the groups.
Interpretation:
Full and limited FESS are both effective in improving HRQoL in patients with CRSwNP within 24 months. Decrease in total SNOT-22 scores exceeded the minimal clinically meaningful difference in both groups, but this difference was not met between the groups at 12 or 24 months. Postoperative differences between the groups in secondary outcomes may represent better inflammatory control after full FESS.
Trial Registration:
ClinicalTrials.gov, NCT03704415. Registered on the 8th October 2018.