Abstract
Background: Over the last few years, various techniques have been proposed for performing tonsillectomy in an attempt to lower the morbidity of this surgery. However, controversy still exists regarding the optimal technique involving the least postoperative morbidity. More recently, temperature-controlled radiofrequency has been introduced as a much more effective and safe device for tonsil reduction. Objective: To compare the effectiveness of conventional tonsillectomy versus radiofrequency tonsil ablation with respect to duration of surgery, amount of intraoperative bleeding, recovery time, and postsurgical pain. Materials and Methods: 60 patients were randomly divided into two groups. One group underwent conventional cold ablation tonsillectomy while radiofrequency tonsillectomy was performed in the second group. Duration of surgery, amount of intraoperative bleeding, recovery time, and postsurgical pain (using the Wong-Baker FACES Pain Rating Scale®) were measured. All patients were followed for 24 months. Results: Comparing the radiofrequency tonsillectomy group to the cold dissection tonsillectomy group, the mean duration of surgery was 6.92 versus 18 min, the amount of intraoperative bleeding was 2.75 versus 39.88 mL, and the difference on the postoperative pain scale between the two groups was statistically significant (p < 0.005). There was no recurrence of tonsillitis episodes in either of the 2 groups during the 2-year follow-up period. Conclusion: After adequate training, the radiofrequency technique is beneficial to both the surgeon and the patient, including the possibility to excise tissue and coagulate bleeding vessels with the same device. Postoperative morbidity and complications are lower as compared to the conventional cold dissection technique.
Introduction
Tonsillectomy remains one of the most common surgical procedure worldwide [1]. The most common cause of morbidity following tonsillectomy is attributed to postoperative pain and hemorrhage. Disruption of the underlying mucosa leads to subsequent inflammation and spasm of the pharyngeal muscles causing ischemia and protracted cycle of pain. Inflamed constrictor muscles are a source of intense pain, due to the role these muscles play during swallowing. The intense heat produced by the electrocautery, when used for hemostasis or dissection, causes further tissue damage [2]. Healing of the mucosa occurs by secondary intention usually within 14–21 days. Secondary infection of the tonsillar fossa results in disruption of vessels and secondary hemorrhage, which often requires urgent intervention.
Tonsillectomy has been performed by various techniques such as cold dissection, cryosurgery, monopolar and bipolar diathermy dissection, suction diathermy dissection, bipolar scissor dissection, microscopic bipolar diathermy dissection, ultrasonic removal, laser dissection, and radiofrequency ablation and coblation techniques. However, controversy still exists regarding the optimal technique involving the least postoperative morbidity.
More recently, temperature-controlled radiofrequency has been introduced as a much more effective and safe device for tonsil reduction. This technique generates a plasma field at the probe’s surface, which causes tissue ablation at relatively low temperatures (40–70°C). This plasma field consisting of highly ionized particles breaks down the molecular bonds of local tissue considerably reducing heat dissipation to surrounding structures, as opposed to coagulation by diathermic methods, which generates temperatures greater than 500°C. In addition, the radiofrequency generator can also be used for bipolar coagulation to achieve hemostasis [2].
This prospective study was designed to compare the intraoperative time and intraoperative blood loss and to assess postoperative pain in conventional tonsillectomy and radiofrequency tonsil ablation.
Materials and Methods
A prospective, randomized, single-blinded study was performed in the Department of Otorhinolaryngology at Dr. Ram Manohar Lohia Hospital, New Delhi, India, from August 2014 to July 2016. Informed consent was obtained from all patients and the study was approved by the institution’s ethics board. This study was comprised of 60 patients of either sex planned for tonsillectomy. Informed and written consent was obtained from all patients included in this study.
Subjects were randomly divided into 2 groups. Randomization was performed using a table of random numbers for 30 subjects each. Group 1 included numbers 1–30 while group 2 included numbers 31–60. Each group had randomly distributed 15 even and 15 odd numbers. Study subjects were then allocated numbers according to the randomization. Those allocated with even numbers (group 1) underwent radiofrequency ablation of the tonsil while those in group 2 underwent conventional tonsillectomy by cold dissection.
All patients with signs and symptoms of upper airway obstruction due to tonsillar hypertrophy were included in this study. Patients with acute tonsillitis, bleeding disorders, neuropsychiatric disorders and patients on long-term analgesics were excluded from this study.
Patients included as a part of this study underwent complete general physical and otorhinolaryngological examination. Intraoperative time, intraoperative hemorrhage, and postoperative pain were observed and documented between the two techniques.
Both surgical techniques were performed by a single surgeon and the observations were documented by a single resident. Intraoperative time was recorded from insertion to removal of Boyle’s Davis mouth gag using a stopwatch. Intraoperative blood loss was calculated by weighing the fossa swabs and measuring collection in suction canister. Postoperative pain was first assessed 6 h following surgery and 8th-hourly thereafter, up till the 3rd postoperative day. Assessment was done using the Wong-Baker FACES Pain Rating Scale (Fig. 1). All patients received the same parenteral antibiotics and analgesics at a fixed time and duration.
Wong-Baker FACES Pain Rating Scale®. ©1983 Wong-Baker FACES Foundation. www.wongbakerFACES.org. Used with permission. Originally published in Whaley and Wong’s Nursing Care of Infants and Children. ©Elsevier Inc.
Wong-Baker FACES Pain Rating Scale®. ©1983 Wong-Baker FACES Foundation. www.wongbakerFACES.org. Used with permission. Originally published in Whaley and Wong’s Nursing Care of Infants and Children. ©Elsevier Inc.
Statistical Analysis
Apart from the descriptive analysis of the data collected, statistical significance between group differences was determined using Student’s t test, the Whitney rank-sum test, and the χ2 test.
A p value of < 0.05 was considered to be significant. All statistical analyses were performed using the SPSS (Chicago, IL, USA).
Results
The study population was comprised of 60 patients between 4 and 25 years of age. Patients were randomly divided into 2 groups with 30 patients in each group. The mean age of group 1 was 12.47 years (8–18), while in group 2, the mean age was 10 years (5–25). Group 1 was comprised of 10 females (33.3%) and 20 males (66.6%), while group 2 was comprised of 17 females (57%) and 13 males (43.3%). The majority of the patients (51.67%) was less than 10 years of age. There were no significant differences in age distribution nor gender distribution (p = 0.450 and 0.482, respectively) (Tables 1-3).
Symmetric tonsillar hypertrophy was present in all patients included in this study. Dysphagia was the associated symptom in 7 patients (11.67%). 55 patients (91.66%) presented with grade III hypertrophy of the tonsil while 5 (8.33%) presented with grade II hypertrophy.
The mean duration of surgery in group 1 was 6.92 min (4–8) while in group 2, it was 18.08 min (12–32). This difference was statistically significant (p < 0.0005) (Table 4; Fig. 2).
The mean peroperative blood loss in group 1 was only 2.75 mL (range 1.5–4.5) as compared to a mean blood loss of 39.88 mL (range 20–120) in group 2. This difference was statistically significant (p < 0.0005) (Table 5; Fig. 3).
The difference on the postoperative pain scale between the 2 groups was statistically significant. Patients in group 1 were completely free of pain from day 2 onwards, while patients in group 2 complained of pain even at the end of the 3rd postoperative day (Fig. 4).
Discussion
Reduction in morbidity associated with tonsillectomy is important not only with respect to patients’ comfort but also because reduced pain improves oral intake, reduces the risk of dehydration, infection, and postoperative hemorrhage.
Tonsillectomy is one of the most common operation performed by otolaryngologists in the pediatric population [2]. Of particular interest is the peroperative blood loss due to the small total circulating blood volume in younger children and postoperative pain which influences the time taken to resume a normal diet and achieve complete recovery [3]. Radiofrequency tonsil ablation is rapidly growing in popularity since it is associated with a less mean duration of surgery, excellent hemostasis, and minimal postoperative pain.
In our study, the mean duration of surgery in group 1 was 6.92 min (range 4–8) compared to 18.08 min (range 12–32) in group 2, which was statistically significant (p < 0.0005). Nelson [4] demonstrated that the total duration of operating time per tonsil for all ablations averaged 4.5 min, with a range of 1.9–9.4 min, which is similar to our study. Ardehali et al. [5] demonstrated that the mean operation time was 7.81 ± 2.56 min, which was consistent with our study .
Pfaar et al. [6] observed a significantly shorter mean duration of 6.82 min in comparison to 22.64 min for classical tonsillectomy.
Nemati et al. [7], in their study, observed a total mean duration of 16.89 min for radiofrequency tonsil ablation surgery, which was significantly more than in our study.
However, a study reported by Morinière et al. [8] showed no statistically significant difference between the 2 groups in terms of mean operating time.
The mean peroperative blood loss was 2.75 mL (range 1.5–4.5) in group 1 compared with 39.88 mL (range 20–120) in group 2, which was statistically significant.
Friedman et al. [2] observed < 20 mL to no blood loss in their study on radiofrequency tonsil volume reduction. Nelson [4] demonstrated that the operative blood loss for temperature-controlled radiofrequency tonsil reduction is estimated to be less than 1 mL. Blood loss for monopolar electrosurgical tonsil resection and plasma-mediated tonsil ablation in children has been reported to be 83.8 and 90.9 mL, respectively [4]. Given the minimal blood loss with temperature-controlled radiofrequency tonsil reduction, less stringent precautions for airway protection seem reasonable and the less invasive laryngeal mask airway seems to be a safe alternative to endotracheal intubation.
Pfaar et al. [6] also observed that perioperative blood loss was significantly lower and even absent in a considerable number of patients.
Peroperative blood loss is an important consideration in patients with coagulopathies, especially in small children where total circulating blood volume is smaller. None of the patients in our study underwent any damage to adjacent structures (anterior pillar, uvula, and soft palate) peroperatively. There was no case of postoperative hemorrhage in our study.
Pang et al. [9] reported a primary hemorrhage rate of 1.7% (1 child) in the dissection/snare group requiring hemostasis in the theater while both groups had 1 case of secondary hemorrhage due to infection, which was treated conservatively with intravenous antibiotics. Therefore, the postoperative hemorrhage rate for the dissection/snare group was 2.34% compared with the radiofrequency group.
There was a significant difference in mean pain intensity and duration between group 1 and group 2 from the day of surgery to the 3rd day postoperatively. The increase in pain morbidity in the dissection technique group was probably due to slower healing and the extent of dissection done.
In a study reported by Friedman et al. [2], pediatric patients experienced pain for a mean period of 1.7 days following ablation and 7.1 following conventional tonsillectomy. In adults, the mean number of days for which patients experienced pain was 1.6 days following ablation and 9.4 days following tonsillectomy.
In both pediatric and adult patients undergoing ablation, virtually all patients (27 of 28 children and 18 of 22 adults) were pain-free by the 3rd postoperative day. However, patients who underwent conventional tonsillectomy experienced pain beyond the 6th postoperative day in all adults and in 30 out of 40 children undergoing tonsillectomy. A detailed description of the comparison of the two techniques in various studies with respect to pain is enlisted in Table 6.
In our study, we also observed a statistically significant difference in analgesic requirement in the postoperative period over 3 days: in group 1, the mean analgesic requirement was 1.27 g (0.37–5.75) as compared to 5.25 g (2.5–10) in group 2 (Fig. 5; Table 7).
Babademez et al. [10] observed less mean total analgesic requirement postoperatively in the radiofrequency tonsil ablation group in a study on the comparison of radiofrequency tonsil ablation and coblation technique.
In a study reported by Ericsson et al. [11], patients who underwent radiofrequency ablation had less pain from the 1st day of surgery, needed less analgesics and were pain-free earlier than the conventional tonsillectomy group. According to Hultcrantz et al. [12], there is no correlation between the quantity of analgesics consumed and the pain experienced by the child, as dispensing analgesics by the parents rather corresponds to the doctor’s prescription than the child’s pain.
In our study, all 60 patients were followed up for 2 years after surgery. Documentation regarding rates of secondary hemorrhage, recurrence of tonsillitis, glossopharyngeal neuralgia, and odynophagia was done.
No patient presented to us with secondary hemorrhage or recurrence of tonsillitis among the 2 groups.
Conclusion
Mucosal-sparing, temperature-controlled radiofrequency tissue volume reduction is a safe and effective method for treating symptoms due to tonsillar hypertrophy in both the pediatric and adult population. Radiofrequency technique results in less operative blood loss, operative time and postoperative pain as compared to conventional cold dissection tonsillectomy. Radiofrequency tonsil ablation also results in decreased analgesic demand in the postoperative period. After adequate training, the radiofrequency technique is beneficial to both the surgeon and patient, including the possibility both to excise tissue and coagulate bleeding vessels with the same device. Postoperative morbidity and complications are lower as compared to the conventional cold dissection technique.
Statement of Ethics
Subjects (or their parents or guardians) have given their written informed consent. The study protocol has been approved by the research institute’s committee on human research. The research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki.
Disclosure Statement
The authors have no conflicts of interest to declare.
Funding Sources
None.
Author Contributions
Dr. Shailendra Kumar: conception, analysis, manuscript drafting, critical analysis, final approval.
Dr. B. Vageesh Padiyar: design, data acquisition, manuscript drafting, critical analysis, final approval.
Dr. Anil Kumar Rai: design, data acquisition, manuscript drafting, critical analysis, final approval.
The abovementioned authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.