Introduction

Although septoplasty is the most frequently performed ear, nose, and throat (ENT) operation in adults, its efficacy is uncertain. There are no randomized controlled trials or non-randomized comparative studies on the effectiveness of septoplasty and the existing literature is methodologically flawed and inconclusive. Evidence-based guidelines on septal surgery is lacking.

Aim

To evaluate the efficacy of septoplasty compared with non-surgical management for nasal obstruction in adults with a deviated septum

Method

Study Design

• Open, multicenter, pragmatic, randomized controlled trial

Treatment Strategy

• The trial recruited adults (aged ≥18 years) with nasal obstruction, a deviated septum, and an indication to have septoplasty done
• Cohort was randomized to receive either septoplasty with or without concurrent turbinate surgery or non-surgical management
• Analyses were stratified by sex, age (<35 years or ≥35 years), deviation severity (mild, moderate, or severe), deviation cause (congenital or traumatic), and type of surgery

  Endpoints

  Primary Endpoint

• Health-related quality of life, measured using patient-reported Glasgow Health Status Inventory (GHSI) at 12 months

  Secondary Endpoints

• Peak nasal inspiratory flow (PNIF)
• Health-related QoL using Nasal Obstruction Symptom Evaluation (NOSE) scale
• Sino-nasal outcome test (SNOT-22)
• Adverse events (AEs)

  Results

• Overall cohort of 203 participants were assigned to receive either septoplasty with or without concurrent turbinate surgery (n=102) or non-surgical management (n=101)
• At 12 months, analyses was done for 94 and 95 subjects from the septoplasty and non-surgical management groups respectively
• Mean age of cohort was 38 years and the median duration of nasal obstruction was 7 years
• Septal deviation was bilateral in 24%
• Turbinate hypertrophy was present in 46%
• The mean GHSI score in the septoplasty group at 12 months was 72·2 (SD 12.2) vs 63.9 (SD 14.5) in non-surgical management group
• The GHSI scores were higher in septoplasty group at 3, 6 and 24 months
• The PNIF before and after decongestion is shown in figure 1.

  Figure 1. PNIF before and after decongestion

  

• The NOSE and SNOT-22 scores favored septoplasty as seen in Figure 2.

  Figure 2. Subjective secondary outcomes at 12 months

  

• The subjective and objective benefits of septoplasty persisted over 24 months
• The incidence of postoperative complications was similar
• The most frequent complications were hemorrhage and infection
• Septal abscess occurred in one surgical patient and septal perforation in two surgical patients
• Revision septoplasty was required in 1 patient
• There were no nasal medication-related AEs

 Conclusion

• Septoplasty offered significant subjective and objective benefits as compared to non-surgical management for nasal obstruction in adults with a deviated septum.
• The benefits were sustained up to 24 months of follow-up.

Lancet. 2019 July 27; 394(10195):314-321.