MD, PhD
Anders Bo Rønnegaard
Department of Otorhinolaryngology - Head and Neck Surgery
| Project management | ||
| Project status | Open | |
| Data collection dates | ||
| Start | 01.04.2025 | |
| End | 01.04.2026 | |
Risk of revision septoplasty following primary septoplasty - a nationwide 10-year follow-up study
Short summary
Surgery on the nasal septum - or septoplasty - is one of the most commonly performed surgical procedures within otolaryngology. In Denmark alone, the procedure is carried out on over 4,000 patients each year. The purpose of this project is to investigate complications related to the procedure as well as the risk of reoperation after surgical correction of the nasal septum. We expect to include 30,000 patients, who will be followed retrospectively for 10 years after their surgery.
Rationale
Septoplasty is widely recognized as one of the most common procedures carried out in the field of ear-nose-and-throat (ENT) surgery. In the United States, it is the third most common ENT procedure carried out, and the number of procedures are increasing (1). Supporting this, data from the Danish National Patient Registry (DNPR) show that more than 4,000 septoplasties are carried out annually in Denmark (2). As this procedure is usually carried out electively, knowledge on the risk of revision septoplasty is highly relevant for clinicians guiding patients in their decision to have surgery performed. However, despite the large number of individuals undergoing septoplasty each year, only few studies have addressed this risk. In his evaluation of 459 septoplasties carried out between 1981 and 1987 and 108 septoplasties carried out in 1996 alone, Gubisch (3) found a revision rate of 5-7%. However, follow-up time was not specified and only extracorporeal septoplasties were evaluated. Furthermore, the sole author of the work was also the primary surgeon on all 459 of the surgeries carried out in the first cohort as well as being the main supervising surgeon for the 108 surgeries performed in 1996. This potentially opens up the study to reporting bias. In 2005, Sedwick et al. (4) reported a revision rate of 5%. However, only 62 patients were included in the study population. Finally, in 2015, Karlsson et al. (5) reported a revision rate of 5% on a cohort of 788 septoplasties. However, follow-up time was not specified and the study design allowed for a potential follow-up of as little as a few months. As such, the risk of revision septoplasty following primary surgery warrants further investigation. The primary aim of this study is to estimate the risk of undergoing revision septoplasty during the first 10 years following primary septoplasty. Secondary aims are to identify risk factors for undergoing revision septoplasty and to identify causes of revision septoplasty. Furthermore, this study will provide basic epidemiological data for septoplasty patients on a vast, nationwide cohort, far exceeding previous sample sizes.
Description of the cohort
All patients registered with septoplasty performed at a Danish hospital between the 1st of January 2000 and 31st of December 2009 in the Danish National Patient Registry (DNPR) will be included in the study. We expect to include at least 30,000 patients with primary septoplasty. These patients will be subjected to a 10-year follow-up period in which any subsequent occurrence of septoplasty will be included for analysis. For example, follow-up for a patient surgically treated on the 1st of January 2002 will be followed up until 1st of January 2012, whereas a patient treated on the 1st of January in 2009 will be followed up until 1st of January 2019. Patients with primary septoplasty will be identified in the DNPR by using the NOMESCO surgical procedure code denoting plastic repair of the nasal septum, DJD20 (6). A recent validation of the DJD20 surgical procedure code in the DNPR carried out by our research team found a positive predictive value of 99%. This study is pending submission for publication. Surgical procedure codes of other nasal structures are expected to include DN* (operations on ethmoidal sinus and bone), DP* (operations on frontal and sphenoidal sinuses), DM* (operations on the maxillary antrum), DH* (operations on the nose - these include surgery of the turbinates). Revision septoplasty will be defined as recurrence of the primary surgical procedure code DJD20 during the 10-year follow-up period. Furthermore, surgical procedure codes of any other ENT specific surgical procedures carried out simultaneously with the primary and revisionary septoplasty will also be extracted from the DNPR. This will be done in order to identify potential differences in the risk of reoperation, depending on simultaneous surgery of other nasal structures, such as the sinuses or turbinates. All subsequent revision septoplasties will be included for analysis. For patients included with primary septoplasty, any subsequent occurrence of traumatic injury to the nasal vicinity of the skull within the follow-up period, will be identified by using the following relevant ICD-10 diagnosis codes: S02.2; S02.3; S02.4; S02.7; S07.9; S07*; S08*; S09.9 (7). Furthermore, diagnosis codes registered alongside the surgical procedure code in the DNPR will also be extracted and analyzed in an attempt to qualify causes of both primary operations and reoperations.
Data and biological material
For this study, data from the DNPR will be cross-linked with two other national registers. For patients that died or emigrated before the conclusion of the follow-up period, date of death and emigration will be obtained from the Danish Civil Registration System (CPR) (8). Data from the Danish National Prescription Registry (LSR) will be used to identify patients with diabetes by active prescriptions for antidiabetic medication at the time of primary surgery (9).