The National Institute for Health and Clinical Excellence is examining tonsillectomy using ultrasonic scalpel and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about tonsillectomy using ultrasonic scalpel.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.

The Advisory Committee will then prepare draft guidance which will be the basis for the Institute’s guidance on the use of the procedure in the NHS in England, Wales and Scotland.

• For further details, see the Interventional Procedures Programme manual, which is available from the Institute’s website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 28 March 2006

Target date for publication of guidance: June 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of tonsillectomy using ultrasonic scalpel appears adequate to support the use of this technique provided that normal arrangements are in place for consent, audit and clinical governance.

The use of ultrasonic scalpel for tonsillectomy may result in higher rates of haemorrhage than other techniques, and clinicians wishing to use ultrasound scalpel should be specifically trained.

Surgeons should ensure that patients or their parents/carers understand the risk of haemorrhage after tonsillectomy using ultrasonic scalpel. In addition, use of the Institute’s Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo).

Surgeons should audit and review the rates of haemorrhage following tonsillectomy in their own practices and in the context of the techniques they use. Publication of further information about the influence of different techniques and other factors (such as age) on the incidence of haemorrhage after tonsillectomy would be useful in guiding future practice.

Indications for tonsillectomy include recurrent acute or chronic tonsillitis, peritonsillar abscess and pharyngeal obstruction/obstructive sleep apnoea. Life-threatening complications of these conditions are rare and the main aim of surgery is to relieve symptoms.

Tonsillectomy has been typically undertaken by ‘cold steel’. Traditional ‘cold steel’ tonsillectomy consists of two stages: removal of the tonsil followed by haemostasis. Bleeding is controlled by pressure, then by ligatures. The use of ligatures may be supplemented by diathermy and the use of packs.

Diathermy uses radiofrequency energy applied directly to the tissue, and it can be bipolar or monopolar. The heat generated may be used in dissection to incise the mucosa and remove the tonsils, and for haemostasis, by coagulating the bleeding vessels. Other methods that use thermal energy include coblation and lasers.

Tonsillectomy using ultrasonic scalpel uses ultrasonic energy to simultaneously dissect through tissues and to seal blood vessels. Tissues are cut by a disposable blade, which vibrates at an ultrasonic frequency, thereby cutting the tissue. This vibration also transfers energy to the tissue, which leads to coagulation and haemostasis. The temperature generated by the vibration is around 55 –100ºC and is lower than that produced by other thermal methods such as diathermy or lasers.

Six studies assessed pain following tonsillectomy using ultrasonic scalpel, cold steel dissection or diathermy. Similar pain scores up to 7 days were reported following each method of tonsillectomy. Three randomised studies reported on pain at 2 weeks or more. In one study of 120 patients, on day 14 only three patients reported any pain, and those were all from the diathermy group (n = 59). In another study in which 32 patients had ultrasonic scalpel tonsillectomy on one side and blunt dissection tonsillectomy on the other, pain was found to be significantly greater on the ultrasonic scalpel side during the second week.

Return to normal diet was assessed in four studies. All four studies reported that patients who had undergone ultrasonic scalpel returned to normal diet at a similar time or earlier than those who had undergone cold steel dissection or diathermy. In one study reporting results on 172 patients, return to normal diet at 1 and 3 days was reported by 44% (43/97) and 74% (72/97), respectively, of the ultrasonic group compared with 23% (17/75) and 47% (35/75) of the diathermy group. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisers did not have any particular concerns about the efficacy of this procedure but noted that the evidence base was still small and that a number of the studies had methodological limitations.

Bleeding is an important complication of tonsillectomy. It can occur intraoperatively, during the first 24 hours after the operation (defined in most studies as primary haemorrhage) or after 24 hours (secondary haemorrhage). Postoperative haemorrhage may require the patient to be readmitted to hospital and may sometimes necessitate further surgery.

In general, primary haemorrhage rates appeared to be lower with the ultrasonic scalpel than with cold steel dissection or diathermy. In a retrospective review of 316 patients, primary haemorrhage occurred in 1% (1/70) of patients in the ultrasonic scalpel group, 3% (3/109) in the diathermy group and 3% (4/132) in the cold dissection group.

In a retrospective review of 407 patients, primary haemorrhage rates for patients treated with ultrasonic scalpel, dissection with monopolar diathermy and dissection with bipolar diathermy were 1% (1/165), 7% (7/102) and 2% (3/140), respectively. However, in most of the studies other techniques (such as ligatures or diathermy) were needed in addition to the ultrasonic scalpel to achieve haemostasis.

Secondary haemorrhage rates varied among the studies. In a randomised controlled trial of 120 paediatric patients, secondary haemorrhage was observed in 8% (5/61) of patients in the ultrasonic group compared with 5% (3/59) in the diathermy group, although these differences were not significant. In a small randomised controlled trial of 21 patients undergoing ultrasonic scalpel tonsillectomy on one side and diathermy on the other side, there were two cases of delayed bleeding – one for each of the two methods. Another within-patient comparative study of ultrasonic scalpel and cold steel dissection tonsillectomy reported that 3 out of 28 patients had delayed bleeding, all of which occurred on the ultrasonic scalpel side. These data are in general agreement with results from the National Prospective Tonsillectomy Audit, which found that the lowest rates of secondary haemorrhage (both those requiring and those not requiring further operation) were associated with cold steel dissection with suture haemostasis, and higher rates were associated with the use of other techniques such as coblation and with the use of diathermy for both dissection and haemostasis. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisers stated that the safety is much the same as for any other method of tonsillectomy; however, it appeared that there was slight increase in postoperative haemorrhage compared with cold steel dissection.

It was noted that the National Prospective Tonsillectomy Audit recommended that all surgeons undertaking tonsillectomy should be trained in the use of cold steel dissection and ligature haemostasis, as well as in the use of any electrosurgical techniques.

The Institute has issued guidance on electrosurgery (diathermy and coblation) for tonsillectomy (www.nice.org.uk/IPG150).

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional procedures overviewoftonsillectomy using ultrasonic scalpel, August 2005

  Available from: www.nice.org.uk/ip242overview