None listed
Conditions
Brief summary
This is a single site, prospective clinical trial aiming to determine if immediate tonsillectomy in patients presenting with acute tonsillitis is a safe and acceptable alternative to delayed elective tonsillectomy for patients with recurrent acute tonsillitis. Currently patients undergo elective tonsillectomy for recurrent tonsillitis but may wait for approximately 12 months on the public hospital waiting list for their procedure, during which time they may suffer further debilitating episodes of tonsillitis. Suitable patients who present to the hospital with acute tonsillitis will receive routine medical management but will proceed to coblation-assisted tonsillectomy under general anaesthesia, a newer surgical technique using a "tonsil wand" with a localised plasma field at the tip for tissue dissection. This approach represents a shift in current treatment paradigms much the same as in other infective surgical pathologies such as acute cholecystitis and appendicitis. We hypothesise that coblation tonsillectomy in the acute setting will be a safe alternative to delayed tonsillectomy, providing the impetus for further larger studies to corroborate these findings.
Interventions
Coblation tonsillectomy will be performed by a single senior ENT surgeon with more than 20years of operating experience at a metropolitan hospital in Sydney, Australia. The recruitment and selection of suitable adult patients to undergo this procedure will be made on a case by case basis, taking into account personalised clinical history and examination findings. A number of factors will be considered, including frequency and severity of episodes of recurrent tonsillitis and the presence of co-morbidities. Tonsillectomy is an operation which can only be performed once on a patient, since the tonsil is removed during in the course of the operation. Tonsillotomy is not being performed. Coblation tonsillectomy is a newer technique which involves dissecting the tonsil from the tonsil bed using a localised plasma field created on a "tonsil wand". A radiofrequency current is produced by a generator and this passes through a field of saline at the tip of the tonsil wand, breaking the molecular bonds to create ions which thereby generate the plasma field for tissue dissection. The plasma field is kept localised at the head of the tonsil wand by the continuous supply and suction of the saline stream. This differs from the traditional techniques used in tonsillectomy, such as "cold steel" tonsillectomy and "diathermy" tonsillectomy. In cold steel tonsillectomy, instruments used include scissors and dissecting forceps, and haemostasis may be achieved with the use of ties, while diathermy tonsillectomy involves the use of electrocautery energy to dissect through the peritonsillar plane. Intra-operative time for coblation tonsillectomy is variable depending on the difficulty of the individual case, but typically would take approximately half an hour or up to one hour. This does not include time for anaesthesia induction and recovery.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients over the age of 16 years with acute tonsillitis, with or without peri-tonsillar abscess, requiring admission to hospital. Symptoms and signs evidencing an episode of acute tonsillitis include fever >38.0 degrees Celsius, tonsillar erythema and/or exudate, sore throat, cervical lymphadenopathy, with or without a culture positive for Group A b-haemolytic Streptococcus. Patient's should additionally warrant tonsillectomy based on their history of clinically significant episodes of sore throat diagnosed as recurrent acute tonsillitis as per the Paradise Criteria (3 episodes per year for previous 3 consecutive years, 5 episodes per year for previous 2 consecutive years, or 7 episodes in the previous year).
Exclusion criteria
Patients under the age of 16 years, patients unable to provide consent, only a single documented episode of acute tonsillitis or where the history of recurrent acute tonsillitis cannot be established, pregnancy, suspected tonsillar malignancy, and if obstructive sleep apnoea is the main indication for tonsillectomy. Patients with bleeding disorders or haematological malignancies, or other significant co-morbidities (patients with American Society of Anaesthesiologists Score 3-4) will also be excluded.