Change in disease-specific quality of life (QOL) 3 months and 1 year after powered intracapsular tonsillectomy and adenoidectomy.
Colen TY, Seidman C, Weedon J, Goldstein NA. Effect of Intracapsular Tonsillectomy on Quality of Life for Children With Obstructive Sleep-Disordered Breathing. Arch Otolaryngol Head Neck Surg. 2008;134(2):124-127. doi:10.1001/archoto.2007.8
To assess the change in disease-specific quality of life (QOL)
in pediatric patients with obstructive sleep-disordered breathing (OSDB) secondary to adenotonsillar hypertrophy after powered intracapsular tonsillectomy and adenoidectomy.
Prospective outcomes study.
Hospital-based pediatric otolaryngology practice.
Fifty children with a mean age of 4.5 years who had a clinical diagnosis of OSDB.
A caregiver of qualifying patients completed a validated QOL survey of pediatric obstructive sleep apnea, the OSA-18 (Obstructive Sleep Apnea-18), preoperatively and 3 months and 1 year postoperatively.
Main Outcome Measure
The OSA-18 mean change scores.
The mean (SD) total OSA-18 change score at the 3-month follow-up visit was 2.3 (1.2) and at the 1 year follow-up visit was 2.2 (1.3). The total and individual domain change scores were significantly improved at both postoperative intervals (P<.001
for all). There were no significant changes in the total or domain change scores between the intervals. The total change score was not significantly associated with either tonsil size or tonsil position.
The OSDB-related QOL is significantly improved after powered intracapsular tonsillectomy and adenoidectomy, and this improvement remains stable even after 1 year.
The quest for the elimination of tonsillectomy-associated morbidity has vexed several generations of otolaryngologists. Postoperative pain, with its attendant sequelae of delayed return to normal diet and activity, is experienced by most patients. This pain is attributed to exposure of the pharyngeal musculature to injury, saliva, bacterial colonization, and subsequent inflammation. Delayed postoperative hemorrhage still occurs in 1% to 3% of patients1 and is due to the exposure of stumps of primary tonsillar feeding vessels. The pediatric population is especially vulnerable to these insults, with a greater propensity for dehydration and life-threatening hemorrhage.
The latest development in thwarting these complications is the resurgence of partial tonsillectomy. Eschewed in the early 20th century as a treatment for recurrent infection due to persistent symptoms from residual tissue, this procedure has been reexamined for its role in the treatment of children with obstructive sleep-disordered breathing (OSDB). Although many techniques have been used, microdebridement has gained popularity for its superior speed and control.2- 7 In this procedure, the microdebrider shaves away most of the tonsil, leaving a small rim overlying the capsule. This “biological dressing” protects the pharyngeal muscles. Blood vessels are thought to be cut distal to arborization; thus, the exposed stumps are from smaller-caliber vessels. Regrowth remains a concern with partial tonsillectomy, and the long-term incidence has yet to be determined. Two studies4,7 have quantified early regrowth across 1 to 2 years as 0.46% and 3.2%, respectively.
The studies published thus far are promising. Retrospective studies2- 4 comparing microdebrider-assisted powered intracapsular tonsillectomy and adenoidectomy (PITA) with total Bovie tonsillectomy and adenoidectomy revealed significantly less postoperative pain and use of analgesics and quicker return to normal diet and activity in the PITA group. The largest of these studies4 showed a significant reduction in delayed postoperative bleeding and hospital readmission for dehydration. Two prospective, randomized, single-masked studies have been published that show more modest benefits. Derkay et al5 found that the PITA group returned to normal activity and stopped taking pain medications sooner, whereas Sobol et al6 found only an earlier return to normal activity. Finally, a recent randomized, double-masked, paired, controlled study by Lister et al8 demonstrated that children noted significantly less postoperative pain on the microdebrider tonsillectomy side than on the Bovie tonsillectomy side. These studies did not find significant differences between the groups with respect to postoperative complications.
The main focus of this study is to assess the change in OSDB-related quality of life (QOL) after PITA. We used 2 separate intervals: 3
months and 1 year postoperatively. Change in QOL at 1 year may be affected by tonsil regrowth. We used a validated QOL survey of pediatric obstructive sleep apnea, the OSA-18 (Obstructive Sleep Apnea-18), which has been shown to have excellent reliability and has been validated as a discriminative instrument using polysomnography9 and as an evaluative survey to demonstrate longitudinal change.10
We also addressed a second question in this study: Are all tonsils treated equally by PITA, or should this procedure be reserved for larger, exophytic tonsils? With endophytic tonsils, a larger percentage of the tonsil may be left behind, and this may have consequences in early relief of OSDB and regrowth of tonsillar tissue across time. Therefore, we examined change in QOL with respect to tonsil size and tonsil position (exophytic, endophytic, or mixed).
The protocol for this study was reviewed and approved by the State University of New York Downstate Medical Center and Long Island College Hospital institutional review boards.
A convenience sample of 50 children who underwent PITA for OSDB between June 1, 2004, and March 31, 2005, were recruited. Caregivers were counseled about the risks and benefits of PITA and total monopolar electrocautery tonsillectomy, and they opted for the former procedure. Caregiver informed consent was obtained, as was assent from all patients older than 7 years. The OSA-18 was completed in writing by each caregiver on the day of surgery, 3 months postoperatively, and 1 year postoperatively. The 3-month interval was chosen as the time when postoperative healing is complete, and the 1-year interval as the longest time that follow-up could be reasonably obtained without attrition of the study group. In addition, these periods have been used in previous related studies.
The inclusion criteria were age 6 months through 12 years, history of snoring and disrupted sleep for 3 months or longer, and being scheduled for PITA as part of routine clinical care. The exclusion criteria were previous tonsil or adenoid surgery, Down or another syndrome involving the head and neck, neuromuscular disorders, cleft palate or previous pharyngeal surgery, known cognitive deficit or mental retardation, known psychiatric disorders, and inability of the caregiver to read and understand English. Twenty-one of 50 patients (42%) underwent preoperative polysomnography. The mean (SD) preoperative apnea-hypopnea index was 12.5 (12.1). Ten of these patients had no desaturations;
of those who did, the mean lowest oxygen desaturation was 86.4%.
All the patients underwent PITA performed by or under the supervision of 2 attending surgeons (N.A.G. and Ari J. Goldsmith, MD). The patient was placed in the Rose position. A mouth gag was applied to retract the mandible. Red rubber catheters were placed via the nares and were used to retract the soft palate. Adenoidectomy was performed using direct mirror visualization with the microdebrider. The nasopharynx was packed with tonsil packs. A Hurd retractor was used to medialize the tonsil while the microdebrider was used to remove the tonsillar tissue, leaving a rim of tissue overlying the capsule. The suction cautery was then used for hemostasis in the cut tonsil and adenoid surfaces. All the patients received a single dose of intravenous dexamethasone sodium phosphate, 0.5 mg/kg, preoperatively and 10 days of postoperative amoxicillin sodium or an equivalent for penicillin-allergic patients.
The OSA-18 consists of 18 items grouped into 5 domains: sleep disturbance, physical symptoms, emotional distress, daytime function, and caregiver concerns. Items are scored on a 7-point ordinal scale that assesses the frequency of specific symptoms, scored as follows:
1, none of the time; 2, hardly any of the time; 3, a little of the time; 4, some of the time; 5, a good bit of the time; 6, most of the time; and 7, all of the time. Item responses are summed to produce a total score ranging from 18 (best QOL) to 126 (poorest QOL). A total score less than 60 suggests a small impact on disease-specific QOL, scores of 60 to 80 suggest a moderate impact, and scores greater than 80 suggest a large impact. A mean survey score and individual domain mean scores are also calculated. The OSA-18 change scores are calculated by subtracting the follow-up mean survey score and the individual domain mean scores from the baseline mean and individual domain mean scores. Positive values indicate clinical improvement and negative values indicate deterioration. A change score of less than 0.5 indicates trivial change; 0.5 to 0.9, small change; 1.0 to 1.4, moderate change;
and 1.5 or greater, large change.9,10
Tonsil size and position were scored intraoperatively. Tonsil size was scored from 1+ through 4+ based on the decrease in pharyngeal lumen diameter: 1+, 0% to 25%; 2+, 26% to 50%; 3+, 51% to 75%; and 4+, 76% to 100%.11 Tonsil position was scored based on protrusion of the tonsil beyond the medial border of the anterior pillar: exophytic, greater than 50% of the tonsil mass medial to the pillar; endophytic, less than 50% medial to the pillar; and mixed, exactly 50% medial to the pillar.
Assuming a standardized difference, defined as the change score divided by the standard deviation of 0.50 (moderate effect), α = .05, and 80% power, 34 patients were required to complete the study. Assuming a dropout rate of 32% (16 patients), we recruited a total of 50 patients.
Exact Wilcoxon signed rank tests were conducted on the change scores at 3 months and 1 year. Spearman correlations of change scores with tonsil size were computed along with their corresponding exact P values. Comparison of median change scores by tonsil position (exophytic vs endophytic vs mixed) was performed using exact Kruskal-Wallis tests. Adjustment of P values for multiple tests was performed using the method of Holm.12 All analyses were performed using a statistical software program (SAS, release 9.1; SAS Institute Inc, Cary, North Carolina) and StatXact 7 Procs for SAS (Cytel Inc, Cambridge, Massachusetts).
Fifty patients underwent PITA: 34 boys and 16 girls. The age range was 1 to 12 years, with a mean of 4.5 years. There were no cases of immediate hemorrhage, delayed hemorrhage, or dehydration. Thirty-eight 3-month postoperative surveys (76%) and 43 1-year surveys (86%) were returned. The degree of baseline oropharyngeal obstruction caused by the tonsils was as follows: 1+, 0 patients; 2+, 8 patients (16%);
3+, 20 patients (40%); and 4+, 22 patients (44%). Tonsil position was exophytic in 19 patients (38%), endophytic in 9 (18%), and mixed in 22 (44%).
The mean (SD) preoperative OSA-18 score was 4.0 (1.4). The mean (SD) total change score at the 3-month follow-up visit was 2.3 (1.2)
and at the 1-year follow-up visit was 2.2 (1.3) (Table). Exact Wilcoxon signed rank tests of change from before surgery to 3 months and from before surgery to 1 year were significant at P < .001
for the total score and for all 5 domains; P values were still significant at that level after adjustment for multiple tests. There were no significant changes in the total or domain change scores between 3 months and 1 year postoperatively (P = .74 for the total score).
Preoperative impact on QOL was small for 17 patients (34%), moderate for 15 (30%), and large for 18 (36%). At the 3-month follow-up, the change in disease-specific QOL from baseline was trivial for 2
of 38 children (5%), small for 2 (5%), moderate for 7 (18%), and large for 27 (71%) (Figure). At the 1-year interval, the change in QOL from baseline was trivial for 5
of 43 children (12%), small for 4 (9%), moderate for 7 (16%), and large for 27 (63%) (Figure). The total change score was not significantly associated with either tonsil size (P = .17 for 3 months and P = .20 for 1 year) or tonsil position (P = .86 for 3 months and P = .72 for 1 year).
The OSDB-related QOL has been addressed in some of the earlier studies of PITA. In the retrospective analysis by Koltai et al,3 caregivers were asked to classify postoperative improvement in QOL as mild, moderate, or marked. Improvement was significant in the total and partial tonsillectomy groups, without significant intergroup differences. Derkay et al5 prospectively assessed obstructive sleep apnea–related QOL at baseline and at 1 month using a validated disease-specific survey, the OSD-6 (Obstructive Sleep Disorders-6). Patients in the electrocautery and microdebrider groups demonstrated significant improvement in all indices. However, there was a significantly larger decrease in the microdebrider group for emotional distress and activity limitation 4 weeks postoperatively. The present results similarly demonstrate significant improvement in the overall OSA-18 score and in each of the 5 domains for the 3-month and 1-year intervals, with 34 patients (85%) experiencing a moderate to large change in QOL at 3 months and 34 (79%) experiencing a moderate to large change at 1 year. This small difference did not prove to be significant.
The mean (SD) total change score at 3-month follow-up of 2.3
(1.2) was similar to the findings of 2 previous studies by Tran et al13 and Goldstein et al14 that used the OSA-18 to evaluate QOL in children with OSDB after total electrocautery tonsillectomy and adenoidectomy. In these studies, the total change scores at 3-month follow-up were a mean (SD) of 2.5 (1.2)13 and a mean of 2.3 (95% confidence interval, 1.9-2.7).14 Mitchell et al15 also used the OSA-18 to evaluate long-term (12-month) changes in QOL after total tonsillectomy and adenoidectomy in children with polysomnographic findings positive for OSA. The mean total change score at 12 months was 2.3 (95% confidence interval, 2.0-2.6), which agrees with the mean (SD) total change score of 2.2 (1.3) in this study. These results suggest that the improvements in QOL after PITA are similar to the improvements after total tonsillectomy and adenoidectomy.
There has been concern that larger, exophytic tonsils would be more amenable to PITA than smaller, endophytic tonsils because more of the tonsil can be removed and there would be less risk of tonsil regrowth. In the present study, tonsil size and position did not significantly affect the OSA-18 change score at either interval. This suggests that tonsil size and position relative to the anterior tonsillar pillar should not limit the use of this procedure for children with OSDB, although longer follow-up is needed to fully assess the risk of tonsil regrowth.
The overall success of total tonsillectomy and adenoidectomy in normalizing polysomnographic indices was reported to be 82.9% (random-effects model 95% confidence interval, 76.2%-89.5%).16 The present patients did not undergo routine preoperative or postoperative polysomnography, so the efficacy of PITA in normalizing polysomnographic measurements is unknown. On the basis of the polysomnography results of the 42% of patients who had preoperative studies, our patient population predominantly had mild to moderate OSDB. We do not know if the severity of OSA affects the success of PITA.
Strengths of this study include its prospective nature, the use of a psychometrically sound survey instrument, and the inclusion of short- and long-term follow-up. Weaknesses include the lack of control group randomization and blinding and a relatively small sample size and incomplete follow-up. Although children as old as 12 years were enrolled, the sample is skewed toward younger children, as evidenced by the mean age of 4.5 years. A larger study with an older mean patient age may have produced different results. A controlled, preferably randomized, study is needed to fully assess the efficacy of PITA.
In conclusion, these outcomes corroborate previous studies that have shown significant improvements in OSDB-related QOL after PITA;
our study shows that this benefit persists even after 1 year. Additional studies using objective measures of OSDB will further clarify PITA's efficacy, and longer-term data will help determine the frequency and clinical impact of tonsil regrowth. These results also suggest that PITA is as effective as total tonsillectomy in improving QOL and that surgeons should not use tonsil size or position as a significant variable in choosing this procedure.
Correspondence: Nira A. Goldstein, MD, Department of Otolaryngology, State University of New York Downstate Medical Center, 450 Clarkson Ave, Box 126, Brooklyn, NY 11203 (firstname.lastname@example.org).
Submitted for Publication: November 22, 2006; final revision received May 24, 2007; accepted June 27, 2007.
Author Contributions: Dr Goldstein had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Colen and Goldstein. Acquisition of data: Colen, Seidman, and Goldstein. Analysis and interpretation of data: Colen and Goldstein. Drafting of the manuscript: Colen. Critical revision of the manuscript for important intellectual content: Colen, Seidman, and Goldstein. Obtained funding: Goldstein. Administrative, technical, and material support: Colen and Goldstein. Study supervision: Goldstein.
Financial Disclosure: None reported.
Previous Presentation: This study was presented as a poster at the 21st Annual Meeting of the American Society of Pediatric Otolaryngology; May 21, 2006; Chicago, Illinois.