Microdebrider-Assisted Intracapsular Tonsillectomy in Adults With Chronic or Recurrent Tonsillitis

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1 The Laryngoscope VC 2015 The American Laryngological, Rhinological and Otological Society, Inc. Microdebrider-Assisted Intracapsular Tonsillectomy in Adults With Chronic or Recurrent Tonsillitis Birte Bender, MD; Elisabeth Constanze Blassnigg, MD; Jana Bechthold, MD; Florian Kral, MD; Ursula Riccabona, MD; Teresa Steinbichler, MD; Herbert Riechelmann, MD Objectives/Hypothesis: We compared the effectiveness and morbidity of microdebrider-assisted total intracapsular tonsillectomy (ICTE) with conventional extracapsular tonsillectomy (ECTE) in adults with chronic or recurrent tonsillitis. Study Design: Prospective randomized surgical trial. Methods: Adult patients with recurrent or chronic tonsillitis who underwent tonsillectomy between July 2010 and July 2012 in the Department of Otorhinolaryngology Head and Neck Surgery, Medical University Innsbruck, Innsbruck, Austria, were consecutively included. Patients were randomized to receive either ICTE or ECTE. Patients and examiners were blinded to the surgical procedure. Effectiveness was assessed with the Tonsil and Adenoid Health Status Instrument (TAHSI). Various parameters of perioperative morbidity and the occurrence of tonsillar remnants were recorded. Results: In the 104 randomized patients, the average TAHSI score was before and after 6 months following tonsillectomy (P < 0.001). TAHSI scores improved equally in patients receiving conventional ECTE (33.6 points; 95% confidence interval (CI), 29.5 to 37.6) and in patients with ICTE (31.8 points; 95% CI, 27.7 to 35.9; between groups P 5 0.6). Posttonsillectomy hemorrhage was more frequent following conventional ECTE (P ). Following ECTE, patients required more pain medication then following ICTE (P < 0.05). Tonsillar remnants were significantly more frequent after ICTE (P < 0,001). However, presence of tonsillar remnants had no influence on postoperative THASI scores (P > 0.5). Conclusion: Tonsillectomy reduced symptoms of chronic or recurrent tonsillitis in adults with remarkable effectiveness. Microdebrider-assisted ICTE reduced symptoms as effectively as conventional ECTE. ICTE was associated with lower morbidity, but residual tonsils occurred in almost half of patients, costs were higher, and the intracapsular approach was more intricate and time-consuming. Key Words: Tonsillectomy, posttonsillectomy hemorrhage, microdebrider, morbidity, adults, tonsillitis. Level of Evidence: 1b. Laryngoscope, 125: , 2015 INTRODUCTION Common indications for tonsillectomy include adenotonsillar hyperplasia with sleep apnea syndrome in children and recurrent or chronic tonsillitis. The effectiveness of tonsillectomy in children with adenotonsillar hyperplasia with sleep disordered breathing is well studied. 1 For obstructive tonsils without chronic or recurrent inflammation, intracapsular partial tonsillectomy (tonsillotomy) has been proven equally effective as standard extracapsular tonsillectomy. During tonsillotomy, nerves and vessels running from the peritonsillar tissues into the tonsillar capsule are preserved. Significantly lower perioperative morbidity following tonsillotomy favors this surgical technique. 2,3 However, tonsillar regrowth may occur. 4,5 Children with recurrent throat infections From the Department of Otorhinolaryngology (B.B., E.C.B., J.B., F.K., T.S., H.R.); and the Department of Anesthesiology and Critical Care Medicine (U.R.), Medical University Innsbruck, Innsbruck, Austria. Editor s Note: This Manuscript was accepted for publication February 23, The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Birte Bender, MD, Department of Otorhinolaryngology, Medical University Innsbruck, Anichstr. 35, 6020 Innsbruck, Austria. birte.bender@i-med.ac.at DOI: /lary benefit from tonsillectomy if the Paradise criteria are met. 6 The role of tonsillectomy in adolescents and adults with chronic or recurrent tonsillitis is less well investigated. Recent reports suggest improved quality of life following tonsillectomy The standard surgical procedure in chronic or recurrent tonsillitis traditionally has been extracapsular tonsillectomy. Partial tonsillectomy was also effective in this patient group ; however, many surgeons are still concerned that recurrent tonsillitis or intratonsillar abscess within the remaining tonsillar tissue may occur following partial tonsillectomy. A technique to remove all lymphatic tonsillar tissue down to the inner surface of the tonsillar capsule (intracapsular tonsillectomy) was first described by Falcao 14 and then a few years later by Champeau. 15 However, these methods did not become popular because conventional dissection along the inner surface of the tonsillar capsule is difficult to perform. Koltai et al. described the use of a microdebrider for tonsillotomy in children with tonsillar hyperplasia. 16 Using a microdebrider allowed for the ablation of almost all of the tonsil tissue, leaving a natural biologic dressing on the inner surface of the tonsil capsule. In a prospective randomized controlled trial, we investigated if microdebrider-assisted total intracapsular

2 tonsillectomy (ICTE) reduces disease symptoms in adults with recurrent or chronic tonsillitis as effectively as conventional extracapsular tonsillectomy (ECTE). Disease symptoms were assessed with the Tonsil and Adenoid Health Status Instrument (TAHSI), which was adapted for adults with recurrent and chronic tonsillitis 17 in an Austrian population. The primary response variable was the difference in pre- and postoperative TAHSI scores in patients treated with ICTE and conventional ECTE. Secondary outcome parameters included various indicators for perioperative morbidity and the frequency of tonsil remnants. MATERIALS AND METHODS In an investigator-initiated prospective randomized trial, two surgical procedures were compared. Patients were not aware whether a conventional ECTE or an ICTE had been performed. The trial was conducted at the Department of Otorhinolaryngology Head and Neck Surgery, Medical University of Innsbruck, Innsbruck, Austria. A positive vote of the Ethics Committee of the Medical University Innsbruck (UN3796) was obtained. Inclusion and Exclusion Criteria Patients between 18 and 65 years with recurrent and/or chronic tonsillitis were included. Recurrent tonsillitis was defined as three or more episodes of acute tonsillitis per year despite adequate medical therapy. Chronic tonsillitis was defined as a chronic inflammation of the tonsils, with a sore throat for at least 3 months, despite adequate medical treatment including antibiotics. Exclusion criteria were suspicion of malignancy, infectious mononucleosis, tonsillar hyperplasia without inflammation, peritonsillar abscess, status postperitonsillar abscess, obstructive sleep apnea syndrome with a documented apnea hypopnea index >10, craniofacial dysmorphism syndromes, Down s syndrome, rheumatoid arthritis, bleeding disorders, nonsteroidal antiinflammatory drug use in the past week, anticoagulation, pregnancy, lactation, American Academy of Anesthesiologists score > 2, status postorgan transplant, psychiatric disease, planned transfer of residence within the next year, and the inability to understand the rationale of the study or study instructions. Randomization and Surgical Procedures Patients complying with the inclusion and exclusion criteria were randomized to either ICTE or conventional ECTE by a randomization plan, which was kindly provided by the Department of Medical Statistics, Informatics and Health Economics, Innsbruck Medical University. For conventional ECTE, the mucosa of the anterior palatal arch was incised, and the tonsillar capsule was identified. Using cold instruments, tonsils were dissected along the capsule. Following ligation at the lower pole, tonsils were cut off at the base of the tongue with a sling. Minor bleedings were coagulated. Major bleedings were ligated in order to avoid excessive coagulation of the wound bed. For ICTE, tonsil tissues protruding medially between the palatine arches were cut off with scissors, and all remnants between the palatine arches were then completely removed with a microdebrider (Storz SCB Unidrive ENT , Karl Storz Endoskop, Vienna, Austria) down to the inner surface of the tonsil capsule. Microdebriders use small, disposable rotating blades to cut the tissue and also have irrigation and aspiration functions. A biologic dressing on the tonsil capsule was left in the tonsillar fossa to protect the underlying blood vessels and nerves. Standardization of Peri- and Postoperative Treatment Perioperative management was standardized to allow comparability of the postoperative course. Postoperative pain management on day 1 to day 5 was standardized in three steps. All patients received paracetamol 4 3 1g 1 naproxen mg as step I medication. If the patient rated pain on a pain scale (0 5 no pain; 10 5 maximum conceivable pain) higher than 3, the treatment level was increased one step. Step II medication consisted of step I, plus additional hydromorphone (modified-release) mg. For step III pain medication, mg hydromorphone (modified-release) was added. Correspondingly, if the pain was scored below 4, pain medication was decreased one step. Tonsil and Adenoid Health Status Instrument The primary response variable of this study was the individual score difference of the TAHSI before and 6 months following tonsillectomy. The TAHSI is a disease-specific questionnaire for tonsil diseases originally developed and validated in children from 2 to 16 years. 17 The adult version of the TAHSI consists of 18 items (Table I), which are summarized in six subscales (airway and breathing, infection, use of health care facilities, feeding and swallowing, medical expenses, behavior). 10 For this study, the questionnaire was translated into German, and some questions were adapted to sociocultural conditions in Central Europe. 18 The final German version of the TAHSI contained eight subscales (recurrent tonsillar infections, chronic tonsillar infection, tonsillar debris and halitosis, swallowing problems, cervical lymph node involvement, health care utilization, school or job performance, fever or bedrest), with two items in each subscale. Total score ranged from 0 to 64, with 0 representing no impairment and 64 representing maximum impairment. Six months after surgery, the score was requested again by telephone interview. A later score was not performed because previous studies showed matching results after 6 and 12 months. 10 The individual pre- and postoperative score differences were compared between both treatment arms using the Mann-Whitney test. Secondary Outcome Parameters To assess perioperative morbidity, posttonsillectomy hemorrhage (PTH), pain, fever, unscheduled medication, postoperative vomiting, and stationary recovery were recorded. Moreover, the presence of residual tonsil was noted at discharge of the patient. In detail, PTH was defined as any bleeding event from the tonsillar fossa after extubation. Severity of PTH was classified using the Stammberger classification (Table II). 19 The number of patients with at least one bleeding event in both treatments arms were compared with chi-square test, and the severity of PTH was compared with an exact Mann-Whitney U test. Posttonsillectomy pain was assessed as follows: All patients received step I pain treatment postoperatively. If the patient judged the pain > 3 on a scale from 0 (no pain at all) to 10 (maximum conceivable pain), pain treatment was increased by one step. The highest step achieved was recorded for each patient and compared in both treatment arms using the exact Mann-Whitney U test. Posttonsillectomy nausea and vomiting, 20 fever (axillary temperature is at or over 37.2 C [99.0 F]), or any unplanned medication were evaluated on the basis of care protocols. The presence of residual tonsils (yes/no) was 2285

3 TABLE I. TAHSI Score. Please Circle the Most Correct Response Over the Past 6 Months, How Much of a Were the Following Conditions for You? Not a Very Mild Moderate Fairly Bad Severe 1 I always had a sore throat for a few days I had bad breath or a bad taste in my mouth I went to a doctorçs office because of a sore throat I had problems with swallowing I had constantly at least a mild sore throat Throat problems affected my performance in school, university, or job I had swollen lymph nodes in the neck Because of a sore throat, I had fever I often had a sore throat for several days I actually had a persistent sore throat Because of my sore throat, medicines had to be obtained from the pharmacy Swallowing was difficult for me I was worried about bad breath and halitosis Because of a sore throat, I was not properly operational at business or in education I even had a slight swelling on my neck, which was sensitive to pressure Because of a throat infection, I had to stay in bed Eight subscales with two items in each subscale (recurrent tonsillar infections: question 1/9; chronic tonsillar infection: question 5/10; tonsillar debris and halitosis: question 2/13; swallowing problems: question 4/12; cervical lymph node involvement: question 7/15; health care utilization: question 3/11; school or job performance: question 6/14; fever or bedrest: question 8/16). In order to focus on inflammatory conditions, symptoms indicating tonsillar hyperplasia including breathing problems, snoring and, obstructive sleep apnea were not included in this version of the questionnaire. TAHSI 5 Tonsil and Adenoid Health Status Instrument. evaluated and recorded on the day of discharge by two physicians. The frequency of residual tonsils in both treatment arms were compared with the chi-square test. Data Handling and Analysis Trial data were recorded in individual case report forms. Data were then transferred to SPSS Version 21 (IBM Corp., Armonk, NY). Frequency data were reported in tabular form; for TAHSI scores, means and standard deviation are provided. For group comparisons of frequency data, Fisher exact test was used. For ordinal or interval data, nonparametric tests (Wilcoxon paired samples and Mann-Whitney U) were employed. To cope with high number of ties, the exact permutational P values provided by the SPSS Exact Tests module were used. All reported P values are two-tailed. RESULTS Between July 2010 and February 2013, 120 patients were screened and 104 patients were included (Fig. 1). The three most common reasons for noninclusion were unwillingness to participate (n 5 8); the patient did not meet inclusion criteria mainly because of age below 18 years (n 5 5); and the patient intended to move and the future address was unknown (n 5 3). Gender, age, and pretreatment TAHSI scores in both treatment arms were balanced (Table III). TAHSI Score The preoperative TAHSI score was obtained in 102 of 104 patients, who were included in this study. The postoperative TAHSI score value could be raised in 90 patients. Pre- and posttreatment TAHSI scores were obtained in 88 of 104 (85%) patients (Fig. 2). Fourteen patients were lost to follow-up. Mean pretreatment TAHSI score (n 5 102) was preoperatively, and at follow-up (n 5 90) it was (Wilcoxon paired samples, n 5 88, P < 0.001). The minimum pretreatment score was 12, and the maximum score was 59. For the total population, the TAHSI score improved 32.7 score points (n 5 88, 95% confidence interval (CI), 29.9 to 35.5). Before treatment, all 102 patients had a TAHSI score >10; at follow-up five of 90 patients had a TAHSI score > 10. Comparing the two treatment arms (ECTE vs. ICTE), the improvement of the TAHSI score did not differ significantly (n 5 88; P 5 0.6) (Fig. 3). In the conventional ECTE group, the mean TAHSI score improved from TABLE II. Stammberger Severity Classification of Posttonsillectomy Hemorrhage. 19 A* Anamnestic only; history of blood in saliva B Bleeding during investigation; treatment required C D E Carry to operating room for general anesthesia; circulation and lab normal Dramatic bleeding, requiring blood transfusion Exitus by bleeding or bleeding-related complications *May be subdivided into A1: dry at inspection, no clot; A2: blood clot at inspection, but no active bleeding after clot removal. May be subdivided into B1: minimal bleeding requiring minimal intervention (e.g., vasoconstriction using epinephrine swab) and B2: electrocautery under topical anesthesia needed. 2286

4 Fig. 1. CONSORT (Consolidated Standards of Reporting Trials) flow diagram modified for nonpharmacologic treatment. 39 TAHSI 5 Tonsil and Adenoid Health Status Instrument points preoperatively (n 5 54) to points postoperatively (n 5 45). In the per protocol analysis (n 5 44), mean improvement was 33.6 points; 95% CI, 29.5 to 37.6; P < 0.001). In the experimental ICTE group, the mean TAHSI score improved from points preoperatively (n 5 49) to points postoperatively (n 5 45). In the per protocol analysis (n 5 44), mean improvement was 31.8 points (95% CI, 27.7 to 35.9). Secondary Outcome Parameters Posttonsillectomy hemorrhage was observed in 22 of 104 (21.2%) patients. Type A bleeding was observed in 16 of 104 patients, and type B bleeding in four of 104 patients. The return to odds ratio (OR) rate (type C) was 6.7% (8/104). Following conventional ECTE, PTH occurred in 16 of 54 (29.6%) patients, whereas PTH was observed in six of 50 (12%) patients in the ICTE group (Fisher exact P ). More than one PTH was observed in five patients in the conventional ECTE arm and in two patients in the ICTE arm. PTH was more severe in the conventional ECTE than in the ICTE group (Table IV). Particularly, type C PTH (return to OR) was more frequent following conventional ECTE (7/ 54) than following ICTE (1/50; P ). Of the 104 included patients, one patient refused any postoperative pain therapy; 66 patients received TABLE III. Pretreatment Patient Data.* Total Conventional ECTE ICTE P Value n Age (mean 6 SD) ,6 Male gender (%) Pretreatment TAHSI score (mean 6 SD; n 5 102) *Age, gender, and pretreatment TAHSI scores were balanced in both treatment arms. ECTE 5 extracapsular tonsillectomy; ICTE 5 intracapsular tonsillectomy; TAHSI 5 Tonsil and Adenoid Health Status Instrument. 2287

5 Fig. 2. TAHSI score values (minimum 0; maximum 64) pre- and 6 months postsurgery. TAHSI 5 Tonsil and Adenoid Health Status Instrument. step I pain treatment; 33 patients received step II; and four patients received step III. Following conventional ECTE, patients received more pain medication than patients after ICTE (Mann-Whitney exact P ). In the conventional ECTE group, 29 patients received step I pain treatment (53.7%), 20 patients received step II (37%), and 4 patients (7.4%) received step III. In the ICTE group, most patients (74%) had pain therapy of stage I and the remaining patients (26%) of stage II. Posttonsillectomy nausea and vomiting was observed in 10 of 54 patients in the conventional ECTE arm and in six of 50 patients in the ICTE arm (Fisher exact P 5 0.4). Postoperative fever was not observed in any patient. In all 104 included patients, the presence of tonsillar remnants was recorded at discharge. Twenty-eight patients (26.9%) were rated to have tonsillar remnants by the physician. Tonsillar remnants were observed in four of 54 (7%) patients in the conventional ECTE arm and in 24 of 50 (48%) patients of the ICTE arm (Fisher s exact P < 0.001). Postoperative TAHSI score of patients with residual tonsils ( ) did not differ significantly from that of patients without residual tonsils ( ; Mann-Whitney P ). DISCUSSION In contrast to conventional extracapsular tonsillectomy, nerves and vessels running from the tonsillar bed to the tonsillar capsule are preserved during tonsillotomy. 21 In children with tonsillar hyperplasia, tonsillotomy leaves parts of normal tonsillar tissue. In this TABLE IV. Most Severe Hemorrhage.* Most Severe Hemorrhage Conventional ECTE ICTE Total Fig. 3. TAHSI score. Representation of the mean value TAHSI score preoperatively (light bars) and postoperatively (dark bars) by surgical procedure. The differences between ICTE and conventional ECTE were not significant (P 5 0.6). ECTE 5 extracapsular tonsillectomy; ICTE 5 intracapsular tonsillectomy; TAHSI 5 Tonsil and Adenoid Health Status Instrument. None A A B B C Total *Type of surgery: crosstabulation. ECTE5 extracapsular tonsillectomy; ICTE 5 intracapsular tonsillectomy. 2288

6 patient group, tonsillotomy reduced hyperplasia-related symptoms as effectively as conventional extracapsular tonsillectomy. The tonsillar remnants did not lead to an increased frequency of recurrences. Moreover, tonsillotomy resulted in less pain and reduced risk of postoperative hemorrhage. In patients with recurrent or chronic tonsillar infections, concerns about persistent or recurrent inflammation or even intratonsillar abscess in the residual tonsil tissue precluded tonsillotomy. 22 Moreover, tonsil regrowth may occur, resulting in disease recurrence. 4,5 Tonsillotomy leaving parts of the inflamed lymphatic tissue did not appear appropriate for surgical treatment of chronic and recurrent tonsillitis, particularly in adults. Employing advanced surgical instruments such as microdebrider, laser, or Coblation (ArthroCare, Austin, TX), it seemed possible to remove all lymphatic tonsil tissue, leaving only the tonsillar capsule in place (total intracapsular tonsillectomy). It was unclear if total intracapsular tonsillectomy reduces disease symptoms as effectively as conventional extracapsular tonsillectomy in adult patients with recurrent or chronic tonsillitis. TAHSI Score In a prospective randomized clinical trial, effectiveness of conventional extracapsular tonsillectomy and microdebrider-assisted total intracapsular tonsillectomy was compared in this patient group. A validated, disease-specific health status instrument served as a measure of disease severity and was the main outcome measure. 10,17,23 The mean preoperative TAHSI score of indicated a surprisingly high impairment by this frequently underestimated disease. Both surgical techniques reduced disease symptoms with outstanding effectivity (P < 0.001) (Fig. 2). This high effectiveness of tonsillectomy in chronic and recurrent tonsillitis in adults is in line with several previous publications. 7,9,10,24 26 The effects are likely to be long-lasting and have a greater impact on younger patients. 8,27 The main result of this trial was that conventional ECTE or microdebrider-assisted ICTE virtually reduced disease symptoms equally as effectively (P 5 0.6) (Fig. 3). The patients were prospectively and consecutively included and randomized to each treatment. Secondary Outcome Parameters Secondary outcome parameters included PTH, postoperative pain, and the frequency of tonsillar remnants at discharge. For PTH, the Stammberger classification (Table II) was used. 19 Overall, a high rate of PTHs (21.6%) was observed. The return to OR rate was 6.7%. This apparently high rate is probably due to the selection of adult patients with chronic inflammatory tonsillar disease. In contrast to children with tonsil hyperplasia, this patient group is at particular risk to develop postoperative hemorrhage. 19,28,29 Following microdebrider-assisted ICTE, significantly fewer patient suffered from PTH than those following conventional ECTE (P ); and in those affected, bleeding was less severe (P ). This is in line with previous studies. 29,30 However, in some studies, microdebrider tonsillectomy was associated with higher intraoperative blood loss than electrocautery tonsillectomy Following ICTE, patient needed less pain treatment than following conventional ECTE (P < 0.05). In the microdebrider-assisted ICTE arm, 26% of patients increased their pain treatment step as compared to 44% in the conventional ECTE arm. Less pain after microdebrider-assisted ICTE than after conventional ECTE was reported by various authors in children. 16,31,33 35 Residual tonsillar tissue after a tonsillectomy may cause recurrences. Tonsillar remnants may lead to tonsillar regrowth and recurrence of the obstructive symptoms following partial tonsillectomy. 4,5,36,37 Derkay et al. observed that tonsillar remnants were more frequent following microdebrider-assisted ICTE than after conventional tonsillectomy using electrocautery. 38 In this study, it was a dedicated surgical goal to remove all lymphatic tonsillar tissue down to the tonsillar capsule with the help of a microdebrider. Apparently, this was difficult to access. At discharge, tonsillar remnants were observed in almost half of the patients following microdebriderassisted ICTE. However, tonsillar remnants were also observed in four patients following ECTE. The presence of tonsillar remnants had no influence on postoperative TAHSI Scores (P 5 0.4). However, in a 17-year-old patient treated outside the study because he was too young for inclusion, a peritonsillar abscess occurred following microdebrider-assisted ICTE originating from a tonsillar remnant. This patient needed revision surgery and claimed compensation. CONCLUSION Microdebrider-assisted ICTE reduced symptoms of chronic or recurrent tonsillitis in adults as effectively as conventional ECTE. Microdebrider-assisted ICTE was associated with less PTH and less postoperative pain. No differences in postoperative nausea and vomiting or postoperative infection were observed. However, regarding the complete removal of tonsillar lymphatic tissue, microdebrider-assisted ICTE was very unreliable. Moreover, microdebrider-assisted ICTE resulted in additional costs and considerably prolonged duration of surgery (data not shown). Additionally, regarding the complete removal of tonsillar lymphatic tissue, microdebrider-assisted ICTE was very unreliable. Compared with the standard procedure, the surgeons participating in this study were overall less satisfied with the microdebrider technique. The amount of blood loss was not measured in this study, but it was reported to be higher by others. Tonsillar remnants had no impact on postoperative symptom scores. However, the number of included patients and the postoperative observation period were by far too low to allow any reliable conclusion on possible recurrences arising from these remnants. BIBLIOGRAPHY 1. Lim J, McKean MC. Adenotonsillectomy for obstructive sleep apnoea in children. Cochrane Database Syst Rev 2009(2):CD doi: / CD pub

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