Randomized controlled study comparing tonsillectomy safety and patient satisfaction outcomes between HARMONIC ACE® + shears and monopolar diathermy in an adult population – A pilot study

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Abstract

Purpose

Various types of the harmonic scalpel blades have been used for tonsillectomy since the early 2000s with varying successes. The HARMONIC ACE® + 23 cm shears is a relatively new blade which has not been studied in an adult population yet.

Methodology

A randomized controlled pilot study was performed comparing the HARMONIC ACE® + 23 cm shears (HS) and monopolar electrocautery (EC) tonsillectomy in 20 patients. Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes were compared between these two arms.

Results

The operative time was comparable. Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm. Post-operative pain scores and use of analgesia were similar. There was earlier return to normal diet and activity in the HS arm compared to the EC arm. More patients in the HS arm recommended using HARMONIC ACE® + 23 cm shears compared to those in the EC arm. This is a non-inferiority study which suggests that the HARMONIC ACE® + 23 cm shears is comparable to monopolar electrocautery in terms of efficacy and post-operative complication rates with better patient satisfaction outcomes. The main weakness of the study is a small study population.

Conclusion

This is the first reported study comparing the use of the HARMONIC ACE® + 23 cm shears with monopolar cautery in tonsillectomy. A prospective adequately powered study validated by objective outcome measures would be useful to verify the findings from this pilot study.

Introduction

Tonsillectomy is one of the most commonly performed otolaryngologic procedures. A variety of techniques [[1], [2], [3], [4], [5]] have been utilised including sharp dissection using knife and dissectors, specially manufactured tonsil guillotines, monopolar diathermy, bipolar diathermy, coblation, lasers and the harmonic scalpel. In the recent two decades, the impetus has been to reduce intraoperative blood loss and post-operative pain. The harmonic scalpel is a comparatively low-energy device that is used for this purpose. Studies comparing the use of harmonic scalpel with conventional tonsillectomy techniques [[5], [6], [7], [8], [9]] have been published since the early 2000s describing varying successes in reducing intraoperative bleeding, post-operative pain as well as delayed haemorrhage. While the clinical advantages of harmonic scalpel tonsillectomy are apparent, patient satisfaction outcomes have not been reported. In addition, the Harmonic ACE + 23 cm shears was first launched and utilised for tonsillectomy in Singapore since 2015. While Salomone et al. [16] compared the use of the harmonic shears with cold dissection in a paediatric population, there have yet been any comparison with monopolar diathermy in terms of its efficacy, patient outcomes and satisfaction in an adult population.

In this paper, we compare the efficacy as well as patient clinical outcomes and satisfaction between Harmonic ACE + Shears and monopolar electrocautery tonsillectomy in a randomized controlled pilot study performed in a heterogenous adult population.

Section snippets

Materials and methods

An Institutional Review Board (IRB) approval (serial number 201507-00145) was obtained. An institutional research grant was awarded to study differences in intraoperative bleeding and post-operative pain between Harmonic ACE + shears tonsillectomy and monopolar diathermy tonsillectomy.

Between 1st June 2016 and 30th June 2017, patients were recruited from the outpatient Otolaryngology clinics of the recruiting tertiary hospital. Inclusion criteria included patients aged between 18 and 65 years

Demographics

A total of 20 patients were recruited and randomized equally into each arm – Harmonic Scalpel (HS) or Electrocautery (EC) tonsillectomy. Two male patients in the electrocautery group defaulted their follow-up appointments.

Operative time

The overall median operative time was 25 min. There was no statistically significant difference in operative times between EC and HS arms (Median: 25 min vs 25 min, P = 0.564).

Intraoperative blood loss

The HS group has a higher proportion of subjects who experienced none or minimal intra-operative

Discussion

The use of harmonic scalpel for tonsillectomy was first reported by Ochi et al. [10] and has demonstrated less post-operative pain and delayed haemorrhage compared to the conventional techniques [5]. The harmonic scalpel uses ultrasonic technology to denature protein by mechanically breaking hydrogen bonds in protein molecules, thus generating much less heat from tissue friction (about 50 °C to 100 °C), which minimises collateral tissue damage. Compared to monopolar and bipolar diathermy, there

Conclusion

This is the first reported study comparing the use of the Harmonic ACE® + 23 cm Shears with monopolar cautery in tonsillectomy. The Harmonic ACE® + 23 cm Shears does not exhibit inferiority to monopolar diathermy in terms of patient safety and efficacy and our results suggest that it is possibly more beneficial in terms of intraoperative bleeding, delayed haemorrhage and post-op recovery. A prospective adequately powered study validated by objective outcome measures would be useful to verify

Author statement

James Kwek: Data curation, Formal analysis, Visualisation, Writing.

Celeste Ann Chua: Methology, Formal analysis, Funding acquisition, Writing.

Xu Shu Hui: Resources, Investigation, Project administration.

Leonard Tan: Methodology, Funding acquisition.

Huang Xin Yong: Methodology, Investigation.

Ian Loh: Conceptualisation, Methodology, Supervision.

Lee Tee Sin: Conceptualisation, Methodology, Supervision, Project administration, Writing.

Grant

Changi General Hospital Institutional Grant.

Declaration of competing interest

The authors have no other conflict of interests to declare.

Acknowledgement

We would like to thank Ms Tan Pei Ting from the Clinical Trials and Research Unit, Changi General Hospital, for her assistance in performing data analysis and verifying the results of our study.

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