Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06119841 |
| Other study ID # |
SDoluoglu |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Saglik Bilimleri Universitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: To compare the efficacy of tonsillectomy and expansion sphincter pharyngoplasty
(ESP) in the surgical treatment of obstructive sleep apnea (OSA).
Methods: Patients with Friedman grade III-IV tonsil hypertrophy and OSA diagnosed with
polysomnography were separated into two groups according to the surgery performed, as the
classic tonsillectomy group (Group 1) and the ESP group (Group 2). The primary endpoint of
the study was to determine the Apnea-Hypopnea Index (AHI) value. The preoperative and
postoperative AHI scores and the decreases in these scores were noted. The change in AHI was
calculated as a percentage (preoperative AHI - postoperative AHI/ preoperative AHI x 100) and
the two groups were compared. An AHI value of <10 events/hour was accepted as cure.
Description:
Obstructive sleep apnea (OSA) is a frequently seen sleep disorder characterised by the
stopping or decrease of air flow, which occurs with the collapse of the upper airway during
sleep. The upper airway can be described as an empty tube and if the air passing through this
tube decreases or stops, an increase in negative pressure occurs, especially in the soft
palate and lateral pharyngeal wall, causing pharyngeal collapse The increase in airway
resistance because of both the upper airway collapse and increase in negative pressure can be
a reason for loud snoring and apnea, and if not treated can also cause systemic
complications. Upper airway obstruction formed in OSA can be due to structural anatomic
factors or to abnormal upper airway motor tonus. The obstruction in the upper airway can
occur in a single or several anatomic regions such as the soft palate, uvula, palatine
tonsils, or tongue root. Treatment modalities include lifestyle changes, continuous positive
airway pressure (CPAP), surgery, and intra-oral devices. The main aim of all treatments is to
expand the upper airway and attempt to reduce airway collapse. In the surgical treatment
applied for this purpose, it is aimed to remove pharyngeal tissue that narrows the upper
airway, increase the stability of the pharyngeal air column, and expand the pharyngeal lumen.
The lateral pharyngeal wall has a complex structure including several pharyngeal muscles such
as the palatopharyngeus, superior pharyngeal constrictor, and palatoglossus, and lymphoid
tissue, and the palatine tonsils. In a previous study, the clinical importance was stated of
lateral pharyngeal wall collapse in the pathogenesis of OSA. It was suggested in that study
that the lateral pharyngeal wall could collapse more easily especially in patients with
severe OSA compared to those without or with mild OSA, and because of this collapse, the
narrowed lateral pharyngeal wall could be an independent risk factor affecting OSA. The
palatine tonsils, especially those of Friedman grade III-IV dimensions, which occupy a large
space in the lateral pharyngeal wall, seem to be a factor causing collapse. In OSA patients
with grade III-IV tonsil hypertrophy, classic tonsillectomy is recommended as first-line
treatment and is still the gold standard surgical method. However, sometimes tonsillectomy
remains insufficient in the treatment of OSA. Therefore, to be able to prevent lateral
pharyngeal wall collapse and increase stability, surgical techniques have been investigated,
and lateral pharyngoplasty, relocation pharyngoplasty, and most recently, expansion sphincter
pharyngoplasty (ESP) have been defined. A previous study has reported that ESP is a suitable
surgical procedure for patients with moderate or severe OSA who have severe palatal
circumferential narrowing and greater lateral pharyngeal wall thickness. A meta-analysis that
included 5 studies also emphasized that ESP was an effective surgical treatment for OSA
patients. However, to the best of our knowledge, there is no study in the literature that has
shown whether or not this surgical technique is superior to classical tonsillectomy. The need
for this method, which is more major surgery than classic tonsillectomy, is not clear.
Therefore, the aim of this study was to investigate and compare the surgical success of
classic tonsillectomy and ESP in OSA surgery performed on a patient series in our hospital.
The study was conducted in the Ear, Nose, and Throat (ENT) Clinic of a city hospital. A full
ENT examination was made of patients with suspected OSA who presented with complaints of loud
snoring, witnessed apnea, and daytime sleepiness. The obstruction localisation was evaluated
using the Müller manoeuvre during the endoscopic examination and only patients with lateral
pharyngeal collapse were included in the study.Then preoperative polysomnography (PSG) was
performed on the patients with Friedman grade III-IV tonsil hypertrophy. The study included
patients aged >18 years with an Apnea-Hypopnea Index (AHI) value of ≥10. Patients were
excluded from the study if they had not undergone preoperative or postoperative PSG, if they
had a craniofacial anomaly such as evident retrognathia, any severe cardiac, respiratory, or
neurological disease, or were determined with an evident obstruction at the tongue base level
in the endoscopic examination.
The patients who underwent surgery for a diagnosis of OSA were separated into two groups as
the classic tonsillectomy (Group 1) and ESP (Group 2) groups. All the operations were
performed by two surgeons experienced in this subject (MM-AI). The patients were hospitalised
for at least 2 days postoperatively, with hydration and pain relief provided.
The primary endpoint of the study was defined as the AHI score. The patients were separated
into 3 subgroups according to the severity of OSA determined in the PSG recording: mild (AHI
≥ 10 and <15 events/hr), moderate (AHI ≥15 and <30 events/hr), and severe (AHI ≥ 30
events/hr). The preoperative and postoperative AHI scores and the decreases in these scores
were noted. The change in AHI was calculated as a percentage (preoperative AHI -
postoperative AHI/ preoperative AHI x 100) and the two groups were compared. An AHI value of
<10 events/hr was accepted as cure. Success was considered as postoperative AHI <20 events/hr
or a 50% reduction in the preoperative AHI.
The daytime sleepiness status of the patients was evaluated using the Epworth Sleepiness
Scale (ESS). A record was made for each patient of body mass index (BMI), smoking status and
alcohol consumption, and history of comorbidities. At postoperative 6 months, PSG was
repeated, the ESS was applied, and BMI was recorded.
All the operations were performed under general anaesthesia. Tonsillectomy was performed with
cold dissection including the whole tonsil and capsule, and bleeding was controlled with
bipolar cauterisation. In the ESP technique, following bilateral tonsillectomy with cold
dissection and bleeding control with bipolar cauterisation, the palatopharyngeus muscle was
identified and a superior-based muscle flap was formed by cutting the upper two-thirds of the
muscle on both sides from the lower third attachment site. By opening tunnels to the anterior
plica mucosa, the dissected palatopharyngeus muscle was placed in these tunnels, and was
sutured to the pterygomandibular raphe with vicryl 2-0 sutures. The mucosal cuts were closed
with vicryl 3-0 sutures. All the patients were discharged on postoperative day 2. Follow-up
examinations were made at the end of postoperative 1 week, 1, 3, and 6 months. The
Clavien-Dindo system was used to evaluate complications.
Statistical Analysis Data analysis was performed using SPSS for Windows, version 26 software
(SPSS Inc., Chicago, IL, USA). Continuous variables were reported as median (minimum-maximum)
values, and categorical variables as number (n) and percentage (%). Nominal variables were
assessed using the Pearson's Chi-square or Fisher's exact test. For parameters that did not
show normal distribution, the Mann-Whitney U test was applied in comparisons. The Wilcoxon
signed-rank test was used to compare pre- and post-surgery AHI scores. A value of p< 0.05 was
considered statistically significant.
