Andrews, PJ;
(2016)
A prospective, controlled study on 131 patients assessing patient safety and nasal function outcomes following human olfactory mucosa biopsy as a source of cells for central nervous system regeneration during endoscopic sinus surgery.
Doctoral thesis , UCL (University College London).
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Abstract
Title A prospective, controlled study on 131 patients assessing patient safety and nasal function outcomes following human olfactory mucosa biopsy as a source of cells for central nervous system regeneration during Endoscopic Sinus Surgery (ESS). Hypotheses The primary hypothesis states; olfactory harvesting is a safe procedure and does not incur a reduction in nasal function including the sense of smell when compared to a control group. The secondary hypothesis states; ESS improves olfactory outcome in CRS patients with nasal polyps (CRSwNP) and CRS without nasal polyps (CRSsNP). Materials and Methods Full Ethical and Research and Development (R&D) approval was granted; Ref: 05/Q0512/103. 131 patients were recruited over a 2 year period and non-randomised into the olfactory biopsy and control arms. Statistical significance was accepted at the 5% level (<0.05) and powered at 80%. Complication rates as well as patient and surgeon reported outcome measures were recorded in each arm both pre operatively and 6 months post operatively. The sense of smell was evaluated using the University of Pennsylvania Smell Identification Test (UPSIT). Results 65 patients underwent superior turbinate biopsy with 66 controls. The complication rate, the nasal function and the sense of smell outcomes of the biopsy group were statistically the same when compared to the control group. In the CRS subgroup analysis the sense of smell improved in both groups following ESS but only in the CRSwNP subgroup was it found to be significant. Conclusions The primary hypothesis was shown to be true and demonstrated that patient morbidity and beneficial outcomes following harvesting human olfactory nasal mucosa during ESS is statistically the same when compared to the control group. The secondary hypothesis was equally shown to be true and demonstrated that sinus surgery improved olfaction in both the CRSwNP and CRSsNP subgroups but only in the CRSwNP subgroup was the olfactory improvement significant.
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