Adenoids and Tonsil Hypertrophy and Its Complications Galioto GB (ed): Tonsils: A Clinically Oriented Update. Adv Otorhinolaryngol. Basel, Karger, 1992, vol 47, pp 227-231
Effect of Adenoidectomy on Eustachian Tube Function Preliminary Results of a Randomized Clinical Trial' Ellen M. Mandel a, Charles D. Bluestone b , Haruo Takahashi b , Margaretha L. Casselbrant b a Department
of Pediatrics; b Division of Pediatric Otolaryngology, Department of Otolaryngology, University of Pittsburgh School of Medicine, Department of Pediatric Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pa., USA
1 This study was supported by Research Grant MCJ-420SI2, Maternal and Child Health Bureau.
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The effects of adenoidectomy on otitis media with effusion (OME) have been described by several investigators [1-6]. However, even in stud~ ies that have shown that adenoidectomy is beneficial, it has not been successful in reducing OME in all the children with OME. If children with OME who might benefit from adenoidectomy can be identified preoperatively by eustachian tube (ET) function testing, it will allow us to spare the child who is unlikely to benefit from adenoidectomy the risks and costs of the procedure. To our knowledge, however, the correlation between the preoperative ET function and the subsequent course of OME has never been analyzed systematically. To determine if preoperative assessment of ET function could aid in selection of patients who might benefit from adenoidectomy, a randomized controlled study was conducted at the Children's Hospital of Pittsburgh. As part of the analysis ofthis study, the effect of adenoidectomy on ET function was examined. Furthermore, ET function in a modified condition of patients (during upper respiratory infection (URI» , which might exaggerate ET dysfunction [7], was also analyzed.
MandellBluestone/Takahashi/Casselbrant
228
Materials and Methods Subjects and Enrollment Subjects were enrolled at the Otitis Media Research Center of the Children's Hospital of Pittsburgh between March 1985 and May 1989. Children between 3 and 12 years of age without any major congenital anomaly or systemic disease, and with ventilation tubes inserted in the previous 6 months for chronic or recurrent middle ear effusion, were eligible for the study. Children who met the above criteria and whose parents gave informed consent were enrolled in this study. Study 1: Randomized Controlled Study of Effect of Adenoidectomy on ET Function Subjects underwent ET function testing at three separate times. The classical inflation-deflation test, forced response test [8], and tubal compliance test [9] were performed each time when possible and the mean values were used as the prerandomization ET function test results. The subjects were randomly assigned to two groups (surgical and control) on the basis of mean closing pressure in the prerandomization period « 50 mm H 20, 50-100 mm H 20, > 150 mm H 20) and presence or absence of nasal obstruction due to obstructive adenoids. For subjects with bilateral tympanostomy tubes, randomization was based on the ear with the higher mean closing pressure. Children assigned to the surgical group underwent adenoidectomy under general anesthesia. After assigned treatment, subjects were followed monthly, and ET function tests were performed every 2 months. The prerandomization ET function tests were compared with those at 2 and 6 months after assigned treatment. Study 2: Effect of Adenoidectomy on ET Function during URI During the posttreatment period, the differences of ET function between the baseline (i.e., non-URI) condition and when a URI was present were compared between the two groups. The ET function data at the time nearest to (usually before) testing during a URI were taken as the baseline data.
Population Characteristics Seventy-four children were randomly assigned to the two treatment groups. Seventy-six percent of subjects were between 4 and 8 years of age; 57% were male. Only 4 (5.4%) were considered to have moderate or severe nasal obstruction. The percentages of subjects with mean closing pressures of> 150, 50-150, < 50 mm H 20 in the surgical group were 18.9, 73.0 and 8.1 %, respectively. The corresponding percentages in the control group were 21.6,70.3 and 8.1 %.
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Results
Adenoidectomy and ET Function
229
Table 1. Results of ET function testing in surgical group Parameter
n
Prerand
2M post
n
Prerand
6M post
OP
29
405± 174
393±152
19
401±134
378± 186
CL
29
122±64
112±61
18
123±46
109±94
PR-12
19
16.7±14.4
17.3± 10.9
13
16.9±7.2
16.5±9.7
PR-24
24
10.6±8.2
10.2±5.7
12
8.5±3.9
7.4±3.0
PR-48
20
6.3±4.3
5.7±2.4
11
5.8± 1.8
4.5 ± 1.3
Tubal compliance
16
2.7±0.8
3.1 ±0.8
7
3.2±0.9
3.0± 1.1
Prerand, 2M post, and 6M post = values at prerandomization period, 2 months and 6 months after randomization, respectively; OP = opening pressure (mm H20); CL = closing pressure (mm H 20); PR-12, PR-24, PR-48 = values of passive resistance (mm H 20/cc/min) at flow rates of 12, 24 and 48; n = number of subjects analyzed.
Study 2: Effect of Adenoidectomy on ET Function during URI There were 13 and 18 children in the surgical and control group, respectively, whose ET functions could be examined both at baseline and with URI. Although opening and closing pressures tended to increase more
Downloaded by: Université de Paris 193.51.85.197 - 1/13/2020 8:56:25 AM
Study 1: Effect of Adenoidectomy on ET Function A total of 56 children (56 ears) were available for this study. The other 18 children either underwent spontaneous extubation (and therefore were unable to be tested) or were lost to follow-up. As shown in table 1, slight decreases in opening and closing pressures were observed both at 2 and 6 months after randomization in the adenoidectomized group, but they were not statistically significant (paired t tests, t = 0.59, 0.74). Improvements in positive pressure equalization and active behavior during swallowing both at 2 and 6 months after randomization were noted, but they were not statistically significant (X 2 tests, X2 = 0.77, 3.47). No significant changes were observed in any other parameter. No significant changes were noted in the control group.
MandellBluestone/Takahashi/Casselbrant
230
during URI in the control group than in the surgical group, none of the differences were statistically significant (X 2 tests, X2 = 2.42, 1.32). No differences were noted in any other parameters.
Discussion Bluestone et al. [10] reported improvement of ET function in some children after adenoidectomy, and Honjo [11] found a significant improvement in ET active function following adenoidectomy. In the present study, no significant change was observed in ET function after adenoidectomy with or without a URI. The clinical effects of adenoidectomy on OM status in this population has not yet been analyzed, but from these results, if a beneficial effect of adenoidectomy on OM is found it cannot be attributed to improvement in the ET function parameters we measured. One important point is that very few of our subjects had large obstructive adenoids. It is quite possible that, in children with large adenoids that can obstruct the ET or the posterior nasal choanae or both, adenoidectomy would show an effect on ET function. On the other hand, Takahashi et al. [5] reported no improvement in active or passive resistance 1 month after adenoidectomy. The present results may have confirmed this with a larger sample size. The questions remaining are how we can predict preoperatively which children will benefit from adenoidectomy, and whether children with nonobstructive adenoids should be candidates for adenoidectomy as the initial procedure. More detailed examinations of the adenoid and the ET by nasopharyngeal endoscopy or magnetic resonance imaging seem to be desirable to further investigate this issue.
2
2 3
Maw AR: Chronic otitis media with effusion (glue ear) and adenotonsillectomy: prospective randomized controlled study. Br Med J 1983;287:1586-1588. Gates GA, Avery CA, Prihoda TJ: Effect of adenoidectomy upon children with chronic otitis media with effusion. Laryngoscope 1988;98:58-63. Paradise JL, Bluestone CD, Rogers KD, Tailor FR, Colborn DK, Bachman RZ, Bernard BS, Schwarzbach RR: Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy-tube placement. JAMA 1990; 263:2066-2073.
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References
Adenoidectomy and ET Function
5 6
7 8 9 10 11
Bu1man CH, Brook SJ, Berry MG: A prospective randomized trial of adenoidectomy vs. grommet insertion in the treatment of glue ear. Clin Otolaryngol 1984;9: 67-75. Takahashi H, Fujita A, Honjo I: Effect of adenoidectomy on otitis media with effusion, tubal function, and sinusitis. Am J Otolaryngol 1989;10:208-213. Fiellau-Nikolajsen M: Tympanometry and secretory otitis media - observations on diagnosis, epidemiology, treatment, and prevention in prospective cohort studies of three-year-old children. Acta Otolaryngol (Stockh) 1983(suppl 394): 1-73. Bluestone CD, Cantekin EI, Beery QC: Effect of inflammation on the ventilatory function of the eustachian tube. Ann Otol Rhinol Laryngol 1977;87:493-507. Cantekin EI, Saez CA, Bluestone CD, Bern SA: Airflow through the eustachian tube. Ann Otol Rhinol Laryngol 1979;88:603-612. Takahashi H, Hayashi M, Honjo I: Compliance of the eustachian tube in patients with otitis media with effusion. Am J Otolaryngol 1987;8:154-156. Bluestone CD, Cantekin EI, Beery QC: Certain effects of adenoidectomy on eustachian tube ventilatory function. Laryngoscope 1975;85: 113-127. Honjo I: Adenoid vegetation and otitis media with effusion; in Eustachian Tube and Middle Ear Diseases. Tokyo, Springer, 1988.
Ellen M. Mandel, MD, Children's Hospital of Pittsburgh, Department of Pediatric Otolaryngology, 3705 Fifth Avenue at DeSoto Street, Pittsburgh, PA 15213 (USA)
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4
231
Effect of Adenoidectomy on Eustachian Tube Function Preliminary Results of a Randomized Clinical Trial' Ellen M. Mandel a, Charles D. Bluestone b , Haruo Takahashi b , Margaretha L. Casselbrant b a Department
of Pediatrics; b Division of Pediatric Otolaryngology, Department of Otolaryngology, University of Pittsburgh School of Medicine, Department of Pediatric Otolaryngology, Children's Hospital of Pittsburgh, Pittsburgh, Pa., USA
1 This study was supported by Research Grant MCJ-420SI2, Maternal and Child Health Bureau.
Downloaded by: Université de Paris 193.51.85.197 - 1/13/2020 8:56:25 AM
The effects of adenoidectomy on otitis media with effusion (OME) have been described by several investigators [1-6]. However, even in stud~ ies that have shown that adenoidectomy is beneficial, it has not been successful in reducing OME in all the children with OME. If children with OME who might benefit from adenoidectomy can be identified preoperatively by eustachian tube (ET) function testing, it will allow us to spare the child who is unlikely to benefit from adenoidectomy the risks and costs of the procedure. To our knowledge, however, the correlation between the preoperative ET function and the subsequent course of OME has never been analyzed systematically. To determine if preoperative assessment of ET function could aid in selection of patients who might benefit from adenoidectomy, a randomized controlled study was conducted at the Children's Hospital of Pittsburgh. As part of the analysis ofthis study, the effect of adenoidectomy on ET function was examined. Furthermore, ET function in a modified condition of patients (during upper respiratory infection (URI» , which might exaggerate ET dysfunction [7], was also analyzed.
MandellBluestone/Takahashi/Casselbrant
228
Materials and Methods Subjects and Enrollment Subjects were enrolled at the Otitis Media Research Center of the Children's Hospital of Pittsburgh between March 1985 and May 1989. Children between 3 and 12 years of age without any major congenital anomaly or systemic disease, and with ventilation tubes inserted in the previous 6 months for chronic or recurrent middle ear effusion, were eligible for the study. Children who met the above criteria and whose parents gave informed consent were enrolled in this study. Study 1: Randomized Controlled Study of Effect of Adenoidectomy on ET Function Subjects underwent ET function testing at three separate times. The classical inflation-deflation test, forced response test [8], and tubal compliance test [9] were performed each time when possible and the mean values were used as the prerandomization ET function test results. The subjects were randomly assigned to two groups (surgical and control) on the basis of mean closing pressure in the prerandomization period « 50 mm H 20, 50-100 mm H 20, > 150 mm H 20) and presence or absence of nasal obstruction due to obstructive adenoids. For subjects with bilateral tympanostomy tubes, randomization was based on the ear with the higher mean closing pressure. Children assigned to the surgical group underwent adenoidectomy under general anesthesia. After assigned treatment, subjects were followed monthly, and ET function tests were performed every 2 months. The prerandomization ET function tests were compared with those at 2 and 6 months after assigned treatment. Study 2: Effect of Adenoidectomy on ET Function during URI During the posttreatment period, the differences of ET function between the baseline (i.e., non-URI) condition and when a URI was present were compared between the two groups. The ET function data at the time nearest to (usually before) testing during a URI were taken as the baseline data.
Population Characteristics Seventy-four children were randomly assigned to the two treatment groups. Seventy-six percent of subjects were between 4 and 8 years of age; 57% were male. Only 4 (5.4%) were considered to have moderate or severe nasal obstruction. The percentages of subjects with mean closing pressures of> 150, 50-150, < 50 mm H 20 in the surgical group were 18.9, 73.0 and 8.1 %, respectively. The corresponding percentages in the control group were 21.6,70.3 and 8.1 %.
Downloaded by: Université de Paris 193.51.85.197 - 1/13/2020 8:56:25 AM
Results
Adenoidectomy and ET Function
229
Table 1. Results of ET function testing in surgical group Parameter
n
Prerand
2M post
n
Prerand
6M post
OP
29
405± 174
393±152
19
401±134
378± 186
CL
29
122±64
112±61
18
123±46
109±94
PR-12
19
16.7±14.4
17.3± 10.9
13
16.9±7.2
16.5±9.7
PR-24
24
10.6±8.2
10.2±5.7
12
8.5±3.9
7.4±3.0
PR-48
20
6.3±4.3
5.7±2.4
11
5.8± 1.8
4.5 ± 1.3
Tubal compliance
16
2.7±0.8
3.1 ±0.8
7
3.2±0.9
3.0± 1.1
Prerand, 2M post, and 6M post = values at prerandomization period, 2 months and 6 months after randomization, respectively; OP = opening pressure (mm H20); CL = closing pressure (mm H 20); PR-12, PR-24, PR-48 = values of passive resistance (mm H 20/cc/min) at flow rates of 12, 24 and 48; n = number of subjects analyzed.
Study 2: Effect of Adenoidectomy on ET Function during URI There were 13 and 18 children in the surgical and control group, respectively, whose ET functions could be examined both at baseline and with URI. Although opening and closing pressures tended to increase more
Downloaded by: Université de Paris 193.51.85.197 - 1/13/2020 8:56:25 AM
Study 1: Effect of Adenoidectomy on ET Function A total of 56 children (56 ears) were available for this study. The other 18 children either underwent spontaneous extubation (and therefore were unable to be tested) or were lost to follow-up. As shown in table 1, slight decreases in opening and closing pressures were observed both at 2 and 6 months after randomization in the adenoidectomized group, but they were not statistically significant (paired t tests, t = 0.59, 0.74). Improvements in positive pressure equalization and active behavior during swallowing both at 2 and 6 months after randomization were noted, but they were not statistically significant (X 2 tests, X2 = 0.77, 3.47). No significant changes were observed in any other parameter. No significant changes were noted in the control group.
MandellBluestone/Takahashi/Casselbrant
230
during URI in the control group than in the surgical group, none of the differences were statistically significant (X 2 tests, X2 = 2.42, 1.32). No differences were noted in any other parameters.
Discussion Bluestone et al. [10] reported improvement of ET function in some children after adenoidectomy, and Honjo [11] found a significant improvement in ET active function following adenoidectomy. In the present study, no significant change was observed in ET function after adenoidectomy with or without a URI. The clinical effects of adenoidectomy on OM status in this population has not yet been analyzed, but from these results, if a beneficial effect of adenoidectomy on OM is found it cannot be attributed to improvement in the ET function parameters we measured. One important point is that very few of our subjects had large obstructive adenoids. It is quite possible that, in children with large adenoids that can obstruct the ET or the posterior nasal choanae or both, adenoidectomy would show an effect on ET function. On the other hand, Takahashi et al. [5] reported no improvement in active or passive resistance 1 month after adenoidectomy. The present results may have confirmed this with a larger sample size. The questions remaining are how we can predict preoperatively which children will benefit from adenoidectomy, and whether children with nonobstructive adenoids should be candidates for adenoidectomy as the initial procedure. More detailed examinations of the adenoid and the ET by nasopharyngeal endoscopy or magnetic resonance imaging seem to be desirable to further investigate this issue.
2
2 3
Maw AR: Chronic otitis media with effusion (glue ear) and adenotonsillectomy: prospective randomized controlled study. Br Med J 1983;287:1586-1588. Gates GA, Avery CA, Prihoda TJ: Effect of adenoidectomy upon children with chronic otitis media with effusion. Laryngoscope 1988;98:58-63. Paradise JL, Bluestone CD, Rogers KD, Tailor FR, Colborn DK, Bachman RZ, Bernard BS, Schwarzbach RR: Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy-tube placement. JAMA 1990; 263:2066-2073.
Downloaded by: Université de Paris 193.51.85.197 - 1/13/2020 8:56:25 AM
References
Adenoidectomy and ET Function
5 6
7 8 9 10 11
Bu1man CH, Brook SJ, Berry MG: A prospective randomized trial of adenoidectomy vs. grommet insertion in the treatment of glue ear. Clin Otolaryngol 1984;9: 67-75. Takahashi H, Fujita A, Honjo I: Effect of adenoidectomy on otitis media with effusion, tubal function, and sinusitis. Am J Otolaryngol 1989;10:208-213. Fiellau-Nikolajsen M: Tympanometry and secretory otitis media - observations on diagnosis, epidemiology, treatment, and prevention in prospective cohort studies of three-year-old children. Acta Otolaryngol (Stockh) 1983(suppl 394): 1-73. Bluestone CD, Cantekin EI, Beery QC: Effect of inflammation on the ventilatory function of the eustachian tube. Ann Otol Rhinol Laryngol 1977;87:493-507. Cantekin EI, Saez CA, Bluestone CD, Bern SA: Airflow through the eustachian tube. Ann Otol Rhinol Laryngol 1979;88:603-612. Takahashi H, Hayashi M, Honjo I: Compliance of the eustachian tube in patients with otitis media with effusion. Am J Otolaryngol 1987;8:154-156. Bluestone CD, Cantekin EI, Beery QC: Certain effects of adenoidectomy on eustachian tube ventilatory function. Laryngoscope 1975;85: 113-127. Honjo I: Adenoid vegetation and otitis media with effusion; in Eustachian Tube and Middle Ear Diseases. Tokyo, Springer, 1988.
Ellen M. Mandel, MD, Children's Hospital of Pittsburgh, Department of Pediatric Otolaryngology, 3705 Fifth Avenue at DeSoto Street, Pittsburgh, PA 15213 (USA)
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4
231
