ABSTRACT
Objective
To evaluate postoperative outcomes and patient‐reported recovery in adult BiZact tonsillectomy.
Methods
In this prospective multicenter study, consecutive adults underwent BiZact tonsillectomy at five institutions. Intraoperative variables included tonsil size, adhesion grade, operative time, and estimated blood loss. Patient‐reported outcomes were collected preoperatively and on postoperative day 1, week 1, and week 8, including pharyngeal pain and otalgia, oral intake, daily activity, bleeding events, time to complete recovery, and satisfaction. Health‐related quality of life was assessed using the Tonsillectomy Outcome Inventory–14 (TOI‐14) preoperatively and at week 8. Time to complete recovery was analyzed using Kaplan–Meier methods, and perioperative outcomes were compared by peritonsillar adhesion severity.
Results
Of 220 enrolled patients, 211 (95.9%) were analyzed (mean age 31.7 years; 60.7% female). Mean operative time was 14.7 min and mean blood loss was 6.5 mL. Pharyngeal pain and otalgia peaked at week 1 and improved by week 8 (p < 0.001). TOI‐14 improved from 27.6 ± 15.9 to 2.9 ± 5.6 at week 8. Postoperative bleeding was reported in 31 patients (14.7%) and 4 patients (1.9%) required operative hemostasis. Median recovery was 14 days for normal activity and regular diet, and 19 days for complete pain resolution. The mean satisfaction score was 9.2 ± 1.4. Higher adhesion grades increased operative time and blood loss, but did not affect postoperative pain, functional recovery, bleeding rates, or TOI‐14 improvement.
Conclusion
BiZact tonsillectomy was associated with acceptable perioperative outcomes and similar patient‐reported recovery patterns across adhesion severity groups, although these findings should be interpreted descriptively in the absence of a control group.
Level of Evidence
4.
Keywords: adult tonsillectomy, BiZact, patient‐reported outcomes, peritonsillar adhesion, Tonsillectomy Outcome Inventory‐14
This prospective multicenter single‐arm cohort study evaluated perioperative outcomes and patient‐reported recovery after BiZact tonsillectomy in 211 adults across five institutions. BiZact tonsillectomy was followed by improved TOI‐14 health‐related quality of life scores at 8 weeks, median recovery times of 14 days for normal activity and regular diet and 19 days for complete pain resolution, with postoperative bleeding reported in 14.7% and operative hemostasis required in 1.9%. Patient‐reported recovery patterns were similar across adhesion severity groups, although these findings should be interpreted descriptively because no comparator arm was included.
1. Introduction
Tonsillectomy is a commonly performed operation in otorhinolaryngology worldwide [1]. Although the procedure is often technically straightforward, it is associated with morbidities such as pain, delayed resumption of regular diet and daily activity, and hemorrhage [2]. These concerns are especially relevant in adults, who frequently experience delayed recovery and a higher bleeding risk than pediatric patients [3]. Since adult tonsillectomy is more frequently indicated for chronic tonsillitis or a history of peritonsillar abscess compared to the pediatric population, significant peritonsillar fibrosis is commonly encountered intraoperatively [4]. Consequently, the selection of surgical technique continues to draw interest as surgeons attempt to improve hemostasis and recovery outcomes.
Tonsillectomy devices are broadly categorized as cold dissection and energy‐based (hot) techniques. Hot approaches, including monopolar electrocautery, coblation, and bipolar vessel‐sealing systems, enable simultaneous dissection and hemostatic control [5]. However, there remains no consensus regarding the optimal method, as outcomes vary across studies and device selection is often guided by surgeons' preference.
BiZact (Medtronic, Minneapolis, MN, USA) is a bipolar vessel‐sealing device developed for tonsillectomy that combines tissue compression with automated energy delivery adjusted by real‐time tissue impedance [6]. The device is designed to seal and divide soft tissue and small vessels while limiting collateral thermal damage, which supports extracapsular dissection and hemostasis.
Early clinical investigations of BiZact have reported low intraoperative blood loss, practical operative times, and acceptable postoperative recovery, including pain and return to normal daily life [7, 8]. Previous studies have included prospective adult cohorts, multicenter pilot series involving adults and children, and reports mainly focused on post‐tonsillectomy hemorrhage. However, the evidence is limited by small sample sizes, mixed‐age populations, heterogeneous outcomes, and a lack of disease‐specific patient‐perceived outcome measures. Therefore, large‐scale prospective adult data remain scarce, despite the distinct postoperative risk in this population.
The aim of this prospective multicenter cohort study was to characterize perioperative outcomes and the postoperative recovery trajectory, including health‐related quality of life (HRQOL) after BiZact tonsillectomy in adults.
2. Material and Methods
2.1. Study Design
This prospective multicenter study included adults aged 19–70 years who underwent BiZact tonsillectomy at five institutions in South Korea from February 2024 to July 2025. Exclusion criteria were concurrent adenoidectomy, unilateral tonsillectomy, previous tonsil surgery, suspected tonsillar neoplasms, and conditions affecting perioperative outcomes, including impaired coagulation, anticoagulant use, chronic analgesic use, or pregnancy. The target enrollment of 220 was based on prior short‐term outcome data, with approximately 200 patients estimated to provide adequate power and 10% added for anticipated dropout [7, 9]. Institutional Review Board approval was obtained at all sites, and all patients provided written informed consent. This study was reported in accordance with the STROBE statement.
2.2. Data Collection
Preoperative variables included age, sex, height, weight, and surgical indication. HRQOL was assessed using the Tonsillectomy Outcome Inventory–14 (TOI‐14), a disease‐specific patient‐reported outcome measure for tonsil‐related symptoms. The TOI‐14 was administered 1 day before surgery based on symptoms during the past 6 months and repeated at 8 weeks postoperatively (Table S1) [10]. Each of the 14 items was scored from 0 to 5, yielding a total score range of 0 to 70, with higher scores indicating greater tonsil‐related symptom burden and poorer HRQOL. A decrease in the TOI‐14 score after surgery was interpreted as improvement in HRQOL.
Intraoperative variables included tonsil size, tonsillar adhesion grade, operative duration, and estimated blood loss. Tonsil size was graded 1–4 using the Friedman tonsil size grading scale, relative to the tonsillar pillars and midline. Grade 1 indicated tonsils contained within the tonsillar pillars; grade 2, tonsils extending to the pillars; grade 3, tonsils extending beyond the pillars but not reaching the midline; and grade 4, tonsils extending to the midline. Grade 0, which represents absent tonsillar tissue, was not applicable in this cohort because patients with previous tonsil surgery were excluded. Tonsillar adhesion was graded 0–3 (0, none; 1, mild; 2, moderate; 3, severe) by the extent of fibrous attachment between the tonsillar capsule and surrounding musculature. Operative duration was defined as the time from insertion to removal of the McIvor mouth gag, and blood loss was estimated from suction canister volume and quantification of blood absorbed in surgical gauze.
Postoperative outcomes were assessed using self‐reported questionnaires completed on postoperative day 1, week 1, and week 8 via a secure mobile messaging application or email. Outcomes included pharyngeal pain, otalgia, body weight, daily activity, oral intake, bleeding events, recovery, and satisfaction. Pharyngeal pain and otalgia were reported using a 0–10 visual analogue scale (VAS). Daily activity was evaluated using a 3‐point scale (0, limited activity; 1, normal activity with some discomfort; 2, fully active without discomfort), and oral intake was classified using a 4‐point scale (1, liquids only; 2, liquids and soft diet; 3, liquids and restricted diet; 4, normal diet). Date of complete recovery of pain, defined as absence of pain without analgesics, as well as recovery of daily activity (grade 2) and oral intake (grade 4) were also reported. Postoperative bleeding was assessed using both patient self‐report and medical record review. Any patient‐reported bleeding was defined as visible blood in the throat or symptoms suggestive of bleeding over 10 min. Clinically significant bleeding outcomes were assessed separately using medical records and included bleeding‐related unscheduled hospital evaluation, hospital admission, and operative hemostasis under general anesthesia. Satisfaction with BiZact tonsillectomy was rated on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).
2.3. Surgical Procedures and Postoperative Management
All surgeons followed a unified BiZact tonsillectomy protocol and attended a preparatory meeting before study initiation to review and standardize operative steps. All procedures were performed under general anesthesia, with the patient positioned supine and the neck slightly extended. Exposure was obtained using a McIvor mouth gag. An initial incision was made along the superior tonsillar mucosa with BiZact while preserving the anterior tonsillar pillar. Once the tonsillar capsule was identified, extracapsular dissection was carried out superior‐to‐inferior and lateral‐to‐medial. To minimize inadvertent bleeding, the peritonsillar fascial plane was fully visualized before applying BiZact, and dissection was performed layer‐by‐layer. Although minor variations were allowed, operative principles were consistent across institutions.
Patients were discharged on postoperative day 1 after confirmation of hemostasis and absence of clinically significant adverse events. Postoperative analgesia consisted of acetaminophen 650 mg, two tablets three times daily with additional Paramacet (acetaminophen 325 mg plus tramadol 37.5 mg), one tablet up to three times daily as needed for breakthrough pain. All patients also received a 1‐week course of a third‐generation cephalosporin, lafutidine, acetylcysteine, and benzydamine hydrochloride gargle.
2.4. Statistical Analysis
Continuous variables are presented as mean ± standard deviation and categorical variables as numbers and percentages. Patients lost to follow‐up were excluded and incomplete questionnaire responses were managed using an available‐case approach. Variables measured at three or more postoperative time points were analyzed using repeated‐measures ANOVA, while outcomes measured twice were compared using paired t‐tests. Time to complete recovery of pain, activity, and oral intake was evaluated using Kaplan–Meier analysis with inverted display demonstrating the cumulative proportion achieving recovery across postoperative days. Statistical analyses were performed using GraphPad Prism (GraphPad Software, v10.4.1, San Diego, CA, USA), and radar plot was generated using RStudio (Version 2025.09.2 + 418).
3. Results
Out of 220 patients enrolled across five institutions, 211 (95.9%) completed postoperative follow‐up and were included in the final analysis. The mean age was 31.7 years (range, 19–64 years), and 128 were female (60.7%). Recurrent tonsillitis and peritonsillar abscess was the most common indication, with tonsillolith and snoring also representing frequent reasons for tonsillectomy (Table 1). Intraoperative findings are summarized in Table 2. Tonsil size grade and tonsillar adhesion grade are presented as categorical distributions. Mean operative time was 14.7 min (range, 4–61), and mean estimated blood loss was 6.5 mL (range, 0–80).
TABLE 1.
Patient demographics.
| Variable | Value | ||
|---|---|---|---|
| Age, years (range) | 31.7 | ±8.8 | (19–64) |
| Sex, N (%) | |||
| Male | 83 | (39.3) | |
| Female | 128 | (60.7) | |
| Height, cm (range) | 167.3 | ±8.2 | (150.0–188.0) |
| Weight, kg (range) | 68.6 | ±15.8 | (41.0–120.0) |
| BMI, kg/m2 (range) | 24.3 | ±4.4 | (16.0–39.0) |
| Indication, N (%) | |||
| Recurrent tonsillitis, peritonsillar abscess | 142 | (67.3) | |
| Snoring | 62 | (29.4) | |
| Tonsillolith | 65 | (30.8) | |
| Others | 1 | (0.5) | |
Note: Continuous variables are presented as mean ± standard deviation, and quantitative variables are presented as numbers and percentages as N (%).
TABLE 2.
Intraoperative findings.
| Variable | Value | |
|---|---|---|
| Tonsil grade, N (%) a | ||
| Grade 1 | 42 | (19.9) |
| Grade 2 | 96 | (45.5) |
| Grade 3 | 62 | (29.4) |
| Grade 4 | 11 | (5.2) |
| Adhesion grade, N (%) a | ||
| Grade 0, none | 87 | (41.2) |
| Grade 1, mild | 71 | (33.6) |
| Grade 2, moderate | 34 | (16.1) |
| Grade 3, severe | 19 | (9.0) |
| Op duration, min (range) | 14.7 ± 10.6 | (4–61) |
| Total blood loss, mL (range) | 6.5 ± 8.0 | (0–80) |
Note: Values are presented as numbers and percentages for categorical variables and as mean ± standard deviation for continuous variables. For bilateral tonsil size and adhesion assessments, the higher grade between the right and left tonsils was used as the patient‐level grade.
Tonsil size grade was assessed using a Friedman tonsil size grading scale from 1 to 4. Adhesion grade represents capsular fibrosis severity from 0 to 3, ranging from no adhesion to severe scarring with obliteration of normal dissection planes.
Postoperative outcomes on day 1, week 1, and week 8 are demonstrated in Table 3. Pharyngeal pain and otalgia both peaked during postoperative week 1 and declined thereafter, with marked resolution by week 8. Pharyngeal pain increased from 4.8 ± 2.2 to 5.5 ± 2.6 on postoperative week 1, then declined to 1.3 ± 2.6 by week 8 (p < 0.001). Otalgia peaked at week 1 (3.4 ± 3.3) and improved to 0.7 ± 1.9 at week 8 (p < 0.001). Oral intake and daily activity decreased transiently after surgery, with most patients returning to normal function by week 8. Body weight decreased temporarily at week 1 but partially recovered by week 8. HRQOL improved significantly, as reflected by a decrease in mean TOI‐14 scores from 27.6 ± 15.9 preoperatively to 2.9 ± 5.6 at week 8 (p < 0.001) with improvement across all symptom domains (Figure 1).
TABLE 3.
Postoperative outcomes.
| Variable | Preop | 1 day postop | 1 week postop | 8 weeks postop | p | ||||
|---|---|---|---|---|---|---|---|---|---|
| Pharyngeal pain, VAS | 4.8 | ±2.2 | 5.5 | ±2.6 | 1.3 | ±2.6 | < 0.001 a | ||
| Otalgia, VAS | 1.6 | ±2.3 | 3.4 | ±3.3 | 0.7 | ±1.9 | < 0.001 a | ||
| Body weight, kg | 68.6 | ±15.8 | 67.3 | ±16.0 | 67.6 | ±15.8 | < 0.001 a | ||
| Daily activity scale | 1.2 | ±0.6 | 0.9 | ±0.5 | 1.9 | ±0.4 | < 0.001 a | ||
| Oral intake scale | 2.4 | ±0.7 | 4.0 | ±0.0 | < 0.001 b | ||||
| TOI‐14 | 27.6 | ±15.9 | 2.9 | ±5.6 | < 0.001 b | ||||
| Patient‐reported bleeding event, N (%) c | 2 | (0.9) | 14 | (6.6) | 31 | (14.7) | |||
| Unscheduled hospital visit, N (%) c | 12 | (5.7) | 22 | (10.4) | |||||
| Bleeding requiring hospital admission, N (%) c | 2 | (0.9) | 10 | (4.7) | |||||
| Bleeding requiring operative hemostasis, N (%) c | 1 | (0.5) | 4 | (1.9) | |||||
Note: Continuous variables are presented as mean ± standard deviation (range) and quantitative variables are presented as numbers and percentages as N (%). Statistical significance was defined as p < 0.05, and significant values are presented in bold.
Abbreviations: TOI‐14, Tonsillectomy Outcome Inventory‐14; VAS, Visual Analogue Scale.
Analyses were performed using repeated‐measures ANOVA.
Analyses were performed using a paired t‐test.
Values are presented as cumulative patient count.
FIGURE 1.
Radar plot demonstrating changes in Tonsillectomy Outcome Inventory‐14 (TOI‐14) domain scores before and after tonsillectomy. Radar chart comparing preoperative TOI‐14 domain scores with scores obtained at 8 weeks postoperatively. Each axis represents one of the 14 symptoms, including difficulty swallowing, sore throat, thick secretions, throat dryness, depressed mood, reduced social activity, healthcare‐related costs, etc. The shaded blue area indicates preoperative symptom severity, while the orange polygon represents postoperative outcomes. Lower scores reflect reduced symptom burden and improved quality of life.
Postoperative bleeding outcomes are summarized in Table 3 as cumulative patient counts. By postoperative week 8, any patient‐reported bleeding was reported in 31 patients (14.7%). The cumulative number of patients with any patient‐reported bleeding was 2 (0.9%) by postoperative day 1, 14 (6.6%) by postoperative week 1, and 31 (14.7%) by postoperative week 8. Accordingly, interval‐specific patient counts were 2 between surgery and postoperative day 1, 12 additional patients between postoperative day 2 and week 1, and 17 additional patients between week 1 and week 8. Among the 31 patients with any patient‐reported bleeding, 9 had self‐limited bleeding without hospital visits, whereas 22 patients (10.4% of the total cohort) underwent bleeding‐related unscheduled hospital evaluation. Hospital admission was required in 10 patients (4.7%), and operative hemostasis under general anesthesia was required in 4 patients (1.9%).
By 8 weeks, almost all patients had resumed normal daily activity, dietary intake, and were free of pain. Median recovery times were 14 days for normal daily activity, 14 days for returning to a regular diet, and 19 days for complete pain resolution (Figure 2).
FIGURE 2.
Cumulative recovery rates for diet, daily activity, and pain after tonsillectomy. Cumulative curves display the proportion of patients achieving complete recovery in diet, daily activity, and pain over postoperative days. The dotted horizontal line marks 50% recovery population, with vertical dashed lines indicating the corresponding time to recovery for each parameter. Median time to recovery was 14 days for return to normal daily activity, 14 days for resuming normal diet, and 19 days for complete pain resolution.
Overall satisfaction was high, with a mean score of 9.2 ± 1.4. A total of 141 patients (66.8%) assigned a score of 10, while scores of 9 and 8 were reported by 21 (10.0%) and 27 (12.8%) patients, respectively. Ratings below 7 were uncommon, and scores of 0–2 were rare (Figure S1).
Postoperative outcomes were also analyzed by peritonsillar adhesion severity (Table 4). A history of peritonsillar abscess was not captured as a discrete, standardized variable across centers; therefore, correlations based specifically on prior abscess history could not be performed, and peritonsillar adhesion grade was used as an intraoperative measure of surgical difficulty. As a result, higher adhesion grades were associated with longer operative times and greater intraoperative blood loss. However, adhesion severity did not significantly affect postoperative pain, functional recovery, bleeding risk, or improvements in TOI‐14 scores. Pain scores on postoperative day 1, week 1, and week 8; weight loss at week 1; and time to recovery of pain, diet, and daily activity were similar between the two adhesion groups. Bleeding occurred in 14.8% of the mild adhesion group and 14.3% of the moderate‐to‐severe adhesion group (p = 0.93). TOI‐14 scores improved significantly in both groups, with comparable reductions.
TABLE 4.
Comparison of perioperative outcomes according to tonsillar adhesion severity.
| None to mild (N = 162) | Moderate to severe (N = 49) | p a | |||
|---|---|---|---|---|---|
| Op duration, min | 12.5 | ±9.5 | 21.8 | ±11.1 | < 0.001 |
| Intraoperative blood loss, mL | 4.7 | ±2.6 | 12.5 | ±14.5 | < 0.001 |
| Postoperative pain, VAS | |||||
| 1 day | 4.9 | ±2.1 | 4.8 | ±2.3 | 0.86 |
| 1 week | 5.4 | ±2.7 | 5.8 | ±2.5 | 0.46 |
| 8 weeks | 1.2 | ±2.5 | 1.5 | ±2.8 | 0.55 |
| Weight loss (1 week), kg | 1.2 | ±4.0 | 1.2 | ±4.8 | 0.97 |
| Full recovery period, POD | |||||
| Complete pain relief | 18.7 | ±10.8 | 18.3 | ±8.9 | 0.86 |
| Normal diet | 16.2 | ±9.4 | 17.7 | ±7.6 | 0.30 |
| Normal daily activity | 14.1 | ±10.4 | 14.5 | ±8.1 | 0.81 |
| Bleeding event, N (%) | 24 | (14.8) | 7 | (14.3) | 0.93 |
| Tonsillectomy Outcome Inventory | |||||
| Preoperative | 27.1 | ±16.3 | 29.5 | ±14.5 | 0.33 |
| 8 weeks postoperative | 3.1 | ±6.1 | 2.5 | ±3.6 | 0.52 |
| ΔTOI (Post−Pre) b | −24 | ±15.9 | −27.1 | ±15.2 | 0.22 |
Note: Continuous variables are presented as mean ± standard deviation (range) and quantitative variables are presented as numbers and percentages as N (%).
Abbreviations: POD, postoperative day; VAS, visual analogue scale.
Statistical significance was defined as p < 0.05, and significant values are presented in bold. All analyses were performed using an unpaired t‐test.
The difference between postoperative and preoperative Tonsillectomy Outcome Inventory scores.
4. Discussion
This prospective multicenter single‐arm study described perioperative outcomes and patient‐reported recovery after BiZact tonsillectomy in a large adult cohort. The observed outcomes showed a predictable postoperative recovery trajectory and significant improvement in HRQOL at 8 weeks. Although tonsillar adhesion severity influenced intraoperative parameters, postoperative recovery measures were comparable between adhesion severity groups. Although these findings may support the applicability and reliability of BiZact across diverse clinical settings, they should be interpreted as descriptive observations within a single‐arm cohort.
Postoperative outcomes followed a predictable course and were consistent with prior post‐tonsillectomy studies. Pharyngeal pain peaked early and declined steadily by postoperative week 8, while otalgia followed a similar pattern, aligning with previously reported VAS profiles [11]. A prospective randomized study comparing coblation and electrocautery likewise demonstrated a transient pain peak at postoperative day 7 followed by gradual improvement [12]. Functional recovery was also predictable. Daily activity decreased early after surgery but fully recovered by week 8, while oral intake progressed from restricted diets at week 1 to normal intake by week 8, consistent with earlier reports [13]. Weight loss at 1 week was modest, with partial recovery by 8 weeks, supporting adequate oral intake during recovery. This is comparable with previous research that demonstrated a mean weight loss of 2.86 kg at postoperative day 7 with partial recovery by day 14 [14]. In cumulative recovery analyses (Figure 2), almost all patients resumed normal daily activity and diet, and achieved complete pain relief by 8 weeks. Median recovery times were 19 days for complete pain resolution and 14 days for return to normal activity and regular diet. These findings are consistent with prior reports showing that functional recovery after adult tonsillectomy commonly occurs over approximately 2 weeks or longer [15].
HRQOL improvement, measured by the TOI‐14, was a key finding of this study. The TOI‐14 is a validated disease‐specific patient‐reported outcome measure for adults with chronic tonsillitis [10]. Baseline scores indicated a moderate symptom burden, consistent with recurrent tonsillitis and tonsillolithiasis [16]. By postoperative week 8, TOI‐14 scores decreased substantially across all domains, including pain, swallowing difficulty, social limitation, and healthcare burden (Figure 1). Prior studies have similarly used the TOI‐14 to assess HRQOL after tonsillectomy and reported meaningful postoperative improvement, which aligns with the magnitude of change observed in our cohort [17]. However, device‐specific evaluations incorporating validated patient‐reported outcomes remain limited. Therefore, our results provide a patient‐reported symptom burden and recovery after adult BiZact tonsillectomy. TOI‐14 scores markedly improved by postoperative week 8, and satisfaction scores were high in this cohort, consistent with prior reports [18]. However, because no comparator group was included, the magnitude of HRQOL improvement cannot be attributed specifically to BiZact or compared with other tonsillectomy techniques.
Operative and bleeding outcomes were summarized descriptively in this cohort. The mean operative time was 14.7 min, which was somewhat longer than that in some prior studies [7], likely reflecting the inclusion of a large adult cohort in our study, in whom operative times are generally longer [19]. Mean intraoperative blood loss was low (6.5 mL) and consistent with prior BiZact studies, including a 2018 pilot study in which > 80% of cases had blood loss < 10 mL and a large adult cohort in which > 70% of procedures had blood loss < 10 mL [7, 9].
Postoperative bleeding outcomes require cautious interpretation as reported rates depend strongly on the definition used. In this study, any patient‐reported bleeding was observed in 31 patients (14.7%). Among these, 22 patients (10.4%) underwent bleeding‐related unscheduled hospital evaluation, 10 patients (4.7%) required admission, and 4 patients (1.9%) required operative hemostasis under general anesthesia. Reported hemorrhage rates vary widely in the literature, including pediatric cohorts, ranging from 1.3% to 20%, with 2.2% to 5% requiring surgical hemostasis [8, 20, 21]. Therefore, the 14.7% overall bleeding rate represents a broad self‐reported endpoint that may include minor or self‐limited bleeding. Although the operative hemostasis rate of 1.9% appears within the range reported for adult tonsillectomy, the overall self‐reported bleeding rate is not negligible and should be considered when counseling adult patients after BiZact tonsillectomy, particularly given that bleeding risk increases with age [22].
Postoperative recovery patterns were also examined according to peritonsillar adhesion severity. Peritonsillar adhesion, resulting from fibrosis and scarring, can obscure the capsular plane leading to technical difficulty during dissection. Accordingly, greater adhesion severity was associated with longer operative time and greater intraoperative blood loss in this cohort, consistent with prior reports [23, 24]. However, postoperative pain, oral intake, daily activity, weight loss, bleeding, and TOI‐14 improvement were not statistically different between adhesion severity groups. These findings suggest similar patient‐reported recovery patterns across adhesion severity groups in this cohort, which is clinically relevant given the multifactorial nature of postoperative pain, bleeding, and HRQOL [25]. The bipolar vessel sealing mechanism of BiZact may provide reliable hemostasis with limited collateral thermal injury, even in difficult dissections. Nevertheless, this subgroup analysis was descriptive and should be interpreted cautiously. Adhesion grading was based on intraoperative surgeon assessment and may have been subjective, and the absence of statistically significant differences should not be interpreted as evidence that BiZact has a device‐specific advantage in surgically difficult cases.
The strengths of this study include its multicenter design, relatively large sample size, prospective data collection, and use of the TOI‐14 as a validated patient‐reported measure. Whereas prior BiZact tonsillectomy studies mainly focused on postoperative pain and hemorrhage, our study provides a broader descriptive assessment of postoperative recovery in adults. In addition, the subgroup analysis by adhesion severity describes patient‐reported recovery patterns across different levels of intraoperative adhesion severity.
Several limitations should be acknowledged. The single‐arm design introduces possible selection bias and limits direct comparison with other techniques. Adhesion grading may have varied among surgeons despite standardized guidance, and the lack of a comparator group prevented direct comparison of BiZact with other tonsillectomy devices. In addition, the subgroup comparison by adhesion severity was not designed as a non‐inferiority analysis; therefore, this should not be interpreted as evidence of device‐specific reliability in difficult cases. Although previous studies have reported outcomes with other tonsillectomy devices, our single‐arm design does not allow conclusions regarding the comparative benefit of BiZact tonsillectomy in adults. Furthermore, a history of peritonsillar abscess was not captured as a discrete variable across centers; therefore, correlations based specifically on prior abscess history could not be performed, and peritonsillar adhesion grade was used as an intraoperative measure of surgical difficulty. Future studies should include randomized controlled trials, more standardized adhesion assessment, and longer‐term follow‐up of HRQOL.
5. Conclusion
In this prospective multicenter single‐arm adult cohort, BiZact tonsillectomy was associated with acceptable perioperative outcomes, improvement in patient‐reported recovery, and improved HRQOL at 8 weeks. Although greater adhesion severity was associated with longer operative time and increased intraoperative blood loss, patient‐reported recovery measures showed similar patterns across adhesion severity groups. These findings may support BiZact as a reliable device for adult tonsillectomy across a broad range of clinical presentations. However, these findings should be interpreted descriptively and should not be considered evidence of comparative safety or superiority.
Funding
This study was supported by a research grant from Medtronic, Inc. (ERP‐2022‐13019). The sponsor had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript; or in the decision to submit the article for publication.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Figure S1: Distribution of patient satisfaction scores at 8 weeks after surgery. Satisfaction was assessed using a numeric rating scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). Bars indicate the number of patients selecting each score, and corresponding percentages are displayed below the x‐axis. A total of 141 patients (66.8%) rated their satisfaction as 10, and 89.6% rated satisfaction at 8 or higher.
Table S1: Tonsillectomy Outcome Inventory–14 (TOI‐14) items administered to patients.
Acknowledgments
The authors have nothing to report.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Figure S1: Distribution of patient satisfaction scores at 8 weeks after surgery. Satisfaction was assessed using a numeric rating scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). Bars indicate the number of patients selecting each score, and corresponding percentages are displayed below the x‐axis. A total of 141 patients (66.8%) rated their satisfaction as 10, and 89.6% rated satisfaction at 8 or higher.
Table S1: Tonsillectomy Outcome Inventory–14 (TOI‐14) items administered to patients.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.