Comparison Between Bipolar Diathermy and Coblation Assisted Tonsillectomy in Pediatric Population: A Randomized Experimental Study

ABSTRACT

Background and Aim

Tonsillectomy is one of the most commonly performed surgical procedures on children. Indications for tonsillectomy include recurrent tonsillitis, obstructive sleep apnea, and peritonsillar abscess, among others. Bipolar diathermy and coblation surgeries are the most common used surgeries. Bipolar Diathermy efficiently manages postoperative hemorrhage but often results in increased postoperative pain due to higher thermal tissue destruction. In contrast, coblation is a procedure that offers a lower output of heat and results in lesser pain and shorter healing times. The present study compares the above two procedures to evaluate the postoperative outcomes regarding pain, healing, and safety of pediatric tonsillectomy patients.

Methods

This was a prospective, randomized, experimental study on 120 pediatric patients ranging from 5 to 14 years who experienced recurrent or chronic tonsillitis or obstructive symptoms, amongst them sleep apnea. Both groups were operated on with extracapsular tonsillectomy under general anaesthesia, with standardized preoperative management and uniform anaesthetic protocols. The aforementioned parameters of pain, hemorrhage, and healing process were similarly followed up for postoperative evaluations at one, two, three, and 4 weeks.

Results

Mean scores of pain were very highly significantly lower in patients of Group A at visits than in patients of Group B. Patients of Group A received scores for visit for the first week at 9.45 ± 0.58 versus 9.82 ± 0.22 (p = 0.001) and scores for visit in the fourth week at 0.35 ± 0.40 versus 1.92 ± 1.78 (p = 0.001). Group A compared with group B had early healing time and fewer cases of bleeding complications. Time to pain resolution was shorter in Group A with a mean of 15.5 ± 2.0 days compared with a mean of 24.8 ± 3.4 days in Group B, (p = 0.001).

Conclusion

The study results show that in pediatric patients, coblation‐assisted tonsillectomy proved to have advantageous benefits over bipolar diathermy tonsillectomy. Coblation provided less postoperative pain and quick healing, with an overall shorter pain duration and fewer bleeding complications.

1. Introduction

Tonsillectomy is among the most common surgeries done on children. In India, rates vary, and it is estimated that 10 per 10,000 people are subjected to this particular surgical intervention, making it one of the most common surgical interventions practiced on children [1]. Common indications for surgery include a peritonsillar abscess, obstructive sleep apnoea, or recurrent bacterial tonsillitis [2]. How far the method applied would be evaluated by postoperative factors like the intensity of pain, the rate of bleeding, and the time span to be taken for the recovery; so this method of surgical intervention is essentially safe and effective. In complicated individual cases, it has been found that the applied method is highly effective in controlling blood loss at intraoperative stages and maintains the security of the patient [3].

Among the available choices, there is still a practice of bipolar diathermy or electrocautery even today. Published studies have revealed that the pain following surgery is more with coblation for bipolar diathermy tonsillectomy. Still, it is one of those reliable and effective ways to ensure that no post‐operative hemorrhages occur [4]. Although this led to increased morbidity postoperatively, it is the procedure that is adopted mainly in areas where good control of blood was necessary [5]. The temperature that is applied in bipolar diathermy is also much higher at 400°C and complete coagulation was ensured though studies have shown that it caused more damage to tissues surrounding the area to be coagulated [6]. Since bipolar diathermy had the benefit of no intraoperative bleeding, pediatric tonsillectomy became a safe procedure through consistent results in different cases [7].

Coblation‐assisted tonsillectomy is a newly developed technique that has gradually gained acceptance in clinical practice. Available studies indicate that postoperative pain and the period of analgesic intake are reduced [8]. The majority of researchers have identified that Coblation has several advantages over electrocautery by inducing lesser amounts of postoperative pain, decreasing the requirement for analgesics, and accelerating recovery. For the pain‐sensitive children, it is essential that this greater accuracy and lower heat impact of the technique cause less damage to structures at risk. Coblation‐assisted tonsillectomy proved to be safe and effective in the surgical removal of tonsillar tissue while maintaining competent haemostasis [9]. With better patient outcomes, this was able to meet the goals of safety and clinical effectiveness.

Given the prevalence of tonsillectomy in children, it is critical to identify the safest and effective surgical technique to enhance patient recovery and reduce associated expenses. Despite the fact that both treatments are commonly used, there are not many thorough research that evaluate their clinical results, cost‐effectiveness, or postoperative problems [10]. The technique selection does have an impact on recovery because it affects the length and intensity of postoperative pain, the amount of analgesics needed, and the occurrence of complications like bleeding, which also affects healthcare costs by determining the number of hospital days and additional treatments needed [3].

As an alternative, coblation‐assisted tonsillectomy has been introduced. Studies have shown after surgery there is reduced pain and shorten the time in which painkillers need to be used. Previous studies have shown that coblation is better than traditional electrocautery because it causes less pain after surgery, reduces the need for painkillers, and shortens the recovery time. The technique's accuracy and reduced thermal output diminished harm to adjacent tissues, a vital consideration for paediatric patients, who are frequently sensitive to pain [4]. Coblation‐assisted tonsillectomy proved to be safe and effective by letting tonsillar tissue be removed safely and effectively while keeping the bleeding under control. This met the goals of clinical efficacy and better patient outcomes [5].

Tonsillectomy is high‐volume surgery in paediatrics, so it is crucial to identify the effective and minimally invasive approach to optimize patient outcomes. Although both the techniques are frequently used, there is lack of very high‐quality, generalizable studies which directly compares their outcomes, particularly in terms of postoperative pain, complications, and healthcare costs [6]. The choice of technique has significant implications for recovery, as it can affect the duration and intensity of postoperative pain, the need for analgesics, and rates of complications, such as bleeding, which can in turn impact healthcare costs by influencing hospital stay length and the need for additional interventions [7, 8].

2. Methodology

This is a prospective, randomized, experimental research trial conducted in the ENT Department of a Tertiary care teaching hospital in Hyderabad, India that ran for 6 months. This study aims to determine the outcome of two tonsillectomy methods: bipolar diathermy and coblation‐assisted tonsillectomy in the paediatric population. Patients were randomized using the ‘chit method’ into two interventional groups, thus denoting fair allocation for every procedure.

2.1. Sample Size

The study included 120 patients were involved in this study who were randomly distributed into two surgical groups, 60 patients in each group who received coblation‐assisted tonsillectomy (Group A), and 60 patients receiving bipolar diathermy (Group B). Sample size used were calculated at power enough to detect differences between postoperative outcomes by two methods [9]. The sample size was calculated to detect a clinically meaningful difference in pain scores with 80% power at a 5% significance level (α = 0.05). This ensured that the study was adequately powered to assess statistically and clinically significant differences between the two surgical techniques.

2.2. Ethical Considerations

The ethical approval for the study was obtained from the Research Ethics Committee (REC), with approval number MS‐606‐2021. Informed consent was also obtained and the guardians of each patient were explained about the procedures. Who agreed to complete follow‐up questionnaires and provide clinical information regarding the patient's recovery. In addition to obtaining written informed consent from the legal guardians, verbal assent was obtained from all pediatric participants.

2.3. Research Protocol and Subjects

The study included paediatric patients aged 5 to 14 years with recurrent or chronic tonsillitis or hypertrophy tonsils resulting in obstructive symptoms, including snoring, sleep apnea, or dysphagia. Patients were enlisted via the otolaryngology outpatient clinic from February to August 2023. Every patient had a comprehensive preoperative assessment, encompassing an extensive medical history, physical examination, and routine preoperative testing to confirm their eligibility for surgery (Figure 1).

Figure 1.

CONSORT flow chart of the study.

2.4. Criteria for Selection

Paediatric patients aged between 4 and 14 years were selected for tonsillectomy in accordance with SIGN guidelines and exhibit symptoms of recurrent tonsillitis or airway blockage, including snoring or sleep apnoea. Selected patients suffered from debilitating episodes of sore throat that disrupted routine everyday activities. Criteria for recurrent sore throats necessitate seven or more recorded, clinically significant, and adequately treated occurrences within the preceding year; five or more episodes in each of the prior 2 years; or three or more episodes annually over the last 3 years. The study excluded all patients older than 14 years. Furthermore, individuals who underwent tonsillectomy for indications other than the primary purpose, such as glossopharyngeal neurectomy or styloid process excision, were excluded. Individuals with a history of peritonsillar abscess occurring within 6 weeks preceding the procedure were deemed ineligible. Individuals with chronic conditions as symptomatic cardiovascular disease, diabetes, coagulation or bleeding disorders, immunodeficiencies, Children with syndromic disorders, and malignancies were excluded from the study. More than that, those with a condition of underlying neurological diseases, which had precluded them from articulating pain, were excluded as well to provide uniformity among the participants. These entry criteria resulted in a homogenous group, ensuring less variability from complex medical problems or varied surgical indications.

2.5. Randomization

In this research, the randomization was done using a very straightforward and effective method of giving control over the bias present in treatment assignment. Upon arriving at the clinic, one card labeled either ‘A’ or ‘B’ was distributed to every guardian. Card ‘A’ represented Coblation‐assisted tonsillectomy, while card ‘B’ indicated bipolar diathermy tonsillectomy (Figure 1). Due to this random assignment process, every patient received an equal chance of belonging to either group which increased the validity of the study and ensured a justifiable test between the two techniques. This treatment with chit system prevented the exposure of the result to selection bias and hence the outcome of the study remained unaffected.

2.6. Preoperative Management

All patients underwent complete clinical examination and recorded medical history at the preoperative work‐up. All the patients underwent a full clinical examination and recording of their medical history. The hematologic tests included complete blood count (CBC), bleeding time (BT), coagulation time (CT), prothrombin time index (PTI), and the international normalized ratio (INR). Radiologic evaluations consisted of chest X‐ray and X‐ray of the nasopharynx for adenoid size assessment.

The night prior to surgery, each patient underwent a preanesthetic evaluation, and the parents gave written consent to receive anaesthesia and surgery. A standard preoperative antibiotic was administered the night before according to the hospital's antibiotic policy, following a test dose and based on a weight‐based titration chart. No topical or local anaesthesia or other medications were administered preoperatively. The anaesthetic protocol was uniform for all patients, with induction via intravenous fentanyl, propofol at 2 mg/kg, and atracurium at 0.5 mg/kg before intubation. A 25‐mcg fentanyl bolus was used intraoperatively in the event that the patient's blood pressure and pulse rate had increased by 20% or more. The surgeon produced a random number sequence used to allocate the patients to their respective groups after a successful induction to anaesthesia. The two groups underwent standard extracapsular tonsillectomy under general anaesthesia with oral endotracheal intubation [9].

The postoperative pain was recorded using the Wong‐Baker FACES Pain Rating Scale. During each follow‐up visit, a trained clinician explained the scale to the child using age‐appropriate language and visual cues. Children were asked to point to the face that best represented their level of pain, ranging from “no pain” to “worst pain.” Their responses were then recorded for each time point.

2.7. Group A – Intervention

Patients in this group underwent Coblation‐assisted tonsillectomy utilizing the Evac 70 Extra Plasma Wand, was executed as a precise and less invasive technique for tonsil excision. The approach integrated radiofrequency radiation with saline to generate a plasma field, enabling the dissolution of tissue at the molecular level without producing excessive heat. In contrast to conventional electrocautery, which functions at elevated temperatures, coblation is performed at reduced temperatures (40°C–70°C), hence mitigating collateral tissue damage. his characteristic was especially beneficial for pediatric patients since it diminished postoperative pain and promoted expedited healing. The surgical technique involved a coagulation level of seven and a power level of three. The intensity and depth of tissue coagulation were regulated by the coagulation setting, while the energy output was governed by the power setting. Utilizing a reduced power level, the surgeons accomplished a controlled and precise dissection, minimizing the risk of haemorrhage and preventing excessive heat damage. The plasma wand concurrently dissected and coagulated tissue, facilitating effective tonsil removal with ongoing haemostasis. This method yielded no blood loss, a significant benefit that enhanced the safety and efficiency of the surgery.

2.8. Group B – Intervention

On the contrary, patients in Group B received bipolar tonsillectomy that was performed using Coviden's straight bipolar forceps, and was done as a procedure known and conventionally using high frequency electrical energy to simultaneously dissect and cauterize the tonsillar tissue. The straight bipolar forceps, set to a power level of 40, provided a precise control of tissue incision and haemostasis. This technique used two tips of the forceps to form a direct electrical circuit. Thereby energy transferred through the tips while minimizing dispersion into adjacent tissue. This formation was notably efficient in reducing thermal diffusion, hence causing less damage to tissues surrounding the area of surgery and thereby reducing postoperative problems such as pain and oedema. The calibrated power setting of 40, or medium power, was used in the process to obtain optimal levels of energy for dissection and cauterization. The bipolar forceps allowed for effective achievement of targeting and coagulation of blood vessels with the resultant dissection of the tonsil from its capsule within maintained haemostasis throughout the surgery. This dual functionality was helpful in reducing the need for accessory devices to achieve haemostasis, hence enhancing surgical productivity. The tonsil was removed using bipolar diathermy in a controlled manner, with effective haemostasis achieved without requiring any accessory coagulation, thus making the surgical field cleaner. Following surgery, all patients were given pain management, consisting of ibuprofen and acetaminophen, in addition to antibiotics (chiefly amoxicillin; clarithromycin or clavulinate were recommended when there was a penicillin allergy).

2.9. Subsequent Evaluations

Patients participated in follow‐up appointments at 1, 2, 3, and 4 weeks after surgery. Every follow‐up included a physical examination conducted by the physician, while guardians responded to enquiries concerning the patient's recovery, including pain levels, bleeding, and healing progress. The research specifically observed the dissolution of the pale healing membrane as an indicator of recovery. To alleviate discomfort and maintain a child‐friendly atmosphere, no photographic documentation of the surgery site was captured; instead, information was gathered through direct evaluations.

2.10. Statistical Test

The statistical analysis was performed using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, NY, USA). The normality was checked using Shapiro‐Wilk test and the data followed normal distribution. The descriptive statistics were used for demographic characteristics. Independent t‐test were applied to compare the baseline differences between two groups. The t‐test were used to assess post changes in each group for pain scores, healing time, and bleeding incidence across multiple time points. A two‐tailed p‐value of < 0.05 was considered statistically significant throughout the study.

3. Result

This investigation was supported by two equal groups of patients in accounting for 120 patients in the study. So within group a where patients had coblation tonsillectomy, and group b where patients had bipolar diathermy tonsillectomy. Factors like age, sex, and the severity and duration of pain, postoperative haemorrhage, and healing status of the patients were reviewed within one, two, and three postoperative week respectively.

Comparison of Patient Demographics: The participants' average age was 7 years old. There were no statistically significant variations between the two groups' demographic features (see Table 1).

Table 1.

Comparison between both groups regarding patients' demographic.

Demographics	Group A (n = 60)	Group B (n = 60)	p‐value
Age			0.126 (Non‐significant)
Range	4–13	4–13
Mean ± SD	8.1 ± 3.2	7.3 ± 2.8
Gender			0.143 (Non‐significant)
Male	29 (48%)	34 (57%)
Female	31 (52%)	26 (43%)

Comparison of Duration and Severity of Postoperative Pain (Tables 2 and 3): Using the Wong‐Baker FACES pain scale, Group A's (coblation) pain scores at each visit varied from 8 to 10, 3–8, 0–5, and 0–1. For the first, second, third, and fourth visits, the corresponding mean pain scores (± standard deviation) were 9.45 ± 0.58, 5.85 ± 1.15, 2.35 ± 1.10, and 0.35 ± 0.40, in that order. The pain scores of Group B (bipolar) ranged from 9 to 10, 7–10, 2–9, and 0–6, with mean scores for the first, second, third, and fourth visits, respectively, of 9.82 ± 0.22, 8.76 ± 0.68, 5.98 ± 1.83, and 1.92 ± 1.78.

Table 2.

Comparison between mean pain scores for both groups on each individual visit.

Visit	Group A (mean ± standard deviation)	Group B (mean ± standard deviation)	p‐value
Mean pain score on 1st visit	9.45 ± 0.58	9.82 ± 0.22	0.001 (significant)
Mean pain score on 2nd visit	5.85 ± 1.15	8.76 ± 0.68	0.001 (significant)
Mean pain score on 3rd visit	2.35 ± 1.10	5.98 ± 1.83	0.001 (significant)
Mean pain score on 4th visit	0.35 ± 0.40	1.92 ± 1.78	0.001 (significant)

Table 3.

Comparison between both groups for different study outcomes.

Study outcome	Group A (n = 60)	Group B (n = 60)	p‐value
Overall mean pain scores			0.001 (significant)
Range	12–23	21–34
Mean ± standard deviation	16.8 ± 2.5	25.4 ± 3.9
Pain duration in days			0.001 (significant)
Range	12–20	22–34
Mean ± standard deviation	15.5 ± 2.0	24.8 ± 3.4
Reactionary and secondary bleeding			0.029 (significant)
Yes	1 (1.7%)	5 (8.3%)
No	59 (98.3%)	55 (91.7%)
Healing (days)			0.001 (significant)
Range	9–18	14–25
Mean ± standard deviation	14.2 ± 2.3	19.5 ± 3.1

Group A and Group B differed significantly (p‐value = 0.001) and Group A mean pain scores at all times were lower. Overall, the average pain scores of Group A were much less than those of Group B.

Group B had noticeably longer pain duration (p = 0.001), but Group A had noticeably less severe pain (p = 0.001). On comparing the Incidence of Postoperative Bleeding there were no incidences of secondary or reactionary bleeding were recorded in Group A. Group B, on the other hand, had five instances of postoperative bleeding. After 24 h, two patients experienced reactive bleeding, two more after 48 h, and one after 4 days and 1 week (both secondary bleeding). After each patient was brought to the hospital, the bleeding was controlled conservatively to avoid the need for further surgery. Similarly while comparison of healing Duration Group B healing process took noticeably longer than Group A, as evidenced by the white healing membrane's total disappearance (p = 0.001). A thorough comparison of the various research outcomes is given in Table 3.

4. Discussion

This study provides a comparison of Coblation‐assisted tonsillectomy and bipolar diathermy tonsillectomy in patient demographics, postoperative pain, bleeding, and healing outcomes.

The demographic analysis was found not to have a significant difference between the two groups hence excluding all possibilities that the observed differences might be due to variations in baseline differences. The observed study results showed that this study found a significantly lower pain score in Group A, coblation, at all points during assessment using the Wong‐Baker FACES pain scale compared to Group B, bipolar. The rate of decrease in pain scores is faster for Group A, whose mean scores decreased from 9.45 ± 0.58 at the first visit to 0.35 ± 0.40 by the fourth visit. However, the relief of pain of Group B was slower, as its mean scores decreased from 9.82 ± 0.22 to 1.92 ± 1.78 during the same duration. This result is somehow in agreement with other published reports that also report less postoperative pain with coblation‐assisted tonsillectomy compared with other methods, including monopolar electrocautery and radiofrequency ablation [11, 12, 13]. Coblation tonsillectomy produces significantly less postoperative pain in the early recovery period compared with bipolar diathermy, as a recent study [13]. The other finding included that Group A did not experience any postoperative bleeding episode, whereas Group B had five episodes of reactive and secondary bleeding. All the cases in Group B bled and were managed conservatively; their appearance certainly does indicate a higher risk profile, most likely to be related to bipolar diathermy. This does tend to align with the literature that has noted coblation‐assisted tonsillectomy to have lower postoperative haemorrhage complications compared with other modes of procedures [14, 15]. Indeed, the cases of Karam et al. (2020) and Belloso et al. (2003) reported also less delayed haemorrhage following coblation tonsillectomy. As evaluated by the reepithelialisation of the white healing membrane, healing was found to be obviously more rapid in Group A than in Group B. The more rapid recovery most likely corresponds to smaller tissue damage and a less severe inflammatory reaction to Coblation‐assisted tonsillectomy that is observed before [7, 10]. Kandemir S, et al. (2023) and Metcalfe C et al. (2017) also have better results referring to the application of analgesia, diet, and recovery of the tonsillar tissue in the framework of coblation tonsillectomy [16, 17].

As this paper did not measure intraoperative outcomes, many other studies have established that bipolar diathermy tonsillectomy, compared with cold dissection, has much reduced operative time and blood loss with equal or comparable postoperative morbidity (Hesham, 2009). This entails that both coblation and bipolar diathermy techniques may provide efficiencies within intraoperative procedures.

4.1. Implications and Clinical Relevance

The results of this study, combined with the existing literature, suggest that Coblation‐assisted tonsillectomy offers several advantages over bipolar diathermy tonsillectomy, including reduced pain severity, shorter pain duration, fewer bleeding complications, and faster healing. These findings highlight coblation as a safer and more patient‐comfort‐oriented technique. The absence of bleeding episodes and faster recovery in Group A could significantly improve the postoperative experience and reduce healthcare resource utilization.

4.2. Limitations and Future Research

While this study provides robust evidence, its sample size and the short‐term follow‐up period limit the generalizability of the findings. This short period, was based on established studies indicating that most postoperative events, including pain resolution and healing, occur within this period [4, 9]. Future studies with larger cohorts and extended follow‐ups are recommended to assess long‐term outcomes and validate these results. The study did not assess cost‐effectiveness, which is an important consideration for surgical decision making it should be addressed in future research. Although a standard protocol was followed for surgical technique and surgeon's experience but they might have influenced outcomes.

Author Contributions

Rabia Azam: conceptualization, writing – original draft, writing – review and editing, project administration, resources, supervision, software, methodology. Asad Alnahar: writing – original draft, writing – review and editing, visualization, project administration, resources, supervision, methodology. Mohammed Abdul Kabir: writing – original draft, writing – review and editing, visualization, resources, supervision, software, methodology. Nawal Mahboob Basha: writing – original draft, writing – review and editing, resources. Imaduddin Mohammed: writing – original draft, writing – review and editing, resources. Gayathri G: writing – original draft, writing – review and editing, resources. Anusha Garapati: writing – original draft, writing – review and editing. Tasneem Sulieman Mohamed Tahameed: writing – original draft, writing – review and editing. Esraa Hamza Abdel Ghani Mohamed: writing – original draft, writing – review and editing. Mohammed Abdul Mateen: writing – review and editing, writing – original draft. Hamza A. Orfali: writing – original draft, writing – review and editing.

Funding

The authors received no specific funding for this work.

Ethics Statement

All authors have read and approved the final version of the manuscript. The corresponding author has full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis. This manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned has been explained.

1. Transparency Statement

The lead author Hamza A. Orfali affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

Data Availability Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.