5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.


Bleeding within the first 7 days after the procedure was reported in 10% (5 of 48) of patients in a retrospective case series of 48 patients with squamous cell carcinoma of the base of the tongue treated by transoral carbon dioxide laser surgery with or without neck dissection (TLS±ND) and adjuvant radiotherapy. The bleeding was from a vessel at the base of the tongue in 1 patient, at the lateral oropharyngeal wall in 1 patient, at the aryepiglottic fold in 1 patient, and from the wound cavity (no further details given) in 2 patients. All complications were managed by micropharyngoscopy with electrocoagulation. Public consultation also reported a single death due to severe haemorrhage.


Severe dysphagia and recurrent aspiration were reported in 6% (3 of 48) of patients in the retrospective case series of 48 patients, as a result of extended tumour resection, including 'resection in adjacent sites and structures'. All 3 patients needed gastrostomy tubes.


Airway loss (needing surgical cricothyroidotomy) was reported in 1 patient in the prospective case series of 204 patients; this occurred during reoperative resection of a tumour-positive margin.


Tracheostomies (permanent or temporary) were needed in 11% (6 of 53) of patients in the TLS±ND group and 5% (9 of 170) of patients in the electrocautery group in the retrospective comparative case series of 223 patients (no significance test reported).


Bilateral hypoglossal nerve paresis (due to 'stretch-related complications' of the endoscopic approach to the pharynx) was reported in 1 patient in the prospective case series of 204 patients. Postoperative 'velopharyngeal incompetence' (not severe enough to prevent oral intake or good speech) was also reported in 11 patients. Further details were not reported.


The specialist advisers listed theoretical adverse events as subcutaneous emphysema, numbness of the tongue, damage to the oral cavity or teeth during access retraction, and inadequate surgical margins.

  • National Institute for Health and Care Excellence (NICE)