None listed
Conditions
Brief summary
Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. This trial will randomise patients to one of these two methods and study post-operative pain outcomes by visual analogue pain scores and days to normal activity. Bleeding during and after surgery, and the duration of surgery, will also be measured. We hypothesize that coblation tonsillectomy will result in reduced post-operative pain, reduced primary and secondary bleeding during and after surgery, a shorter duration of surgery and faster return to normal activity when compared to the Bizact method.
Interventions
Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. Participants will be blinded and randomised to either the Coblation or Bizact tonsillectomy method. These procedures will be performed by highly experienced ENT surgeons. Analgesia will be standardised (Post-surgical analgesia protocol –
Tonsillectomy is a painful procedure, especially in adults. Recent technological advances have allowed new methods of tonsillectomy to be performed. Radiofrequency Coblation and ultrasonic Bizact methods both claim to improve the patient’s pain post-operatively. Participants will be blinded and randomised to either the Coblation or Bizact tonsillectomy method. These procedures will be performed by highly experienced ENT surgeons. Analgesia will be standardised (Post-surgical analgesia protocol – Tapentadol, Celebrex with oxycodone after tapentadol runs out. Difflam for breakthrough). Both Coblation and Bizact tonsillectomy involve pulling the tonsil away from the pharyngeal wall with forceps. The relevant instrument is then used to separate the tonsil capsule from the pharyngeal constrictor muscles. Both instruments provide simultaneous dissection and haemostasis but can sometimes fail to control bleeding 100%, hence the need for “touch-up” bipolar diathermy in some cases. Normal length of procedure would be estimated to be 5-20 minutes in total. The Evac 70 Coblation wand and Bizact ligasure device are disposable devices, hence needing to be recorded in the operation record and can be checked for adherence to the claimed technique.
Sponsors
Professor Simon Carney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Over 18 years of age, able to consent, clinical indications for tonsillectomy as recurrent tonsillitis.
Exclusion criteria
History of bleeding disorders, history of general anaesthetic risk, previous peri-tonsillar abscess, tonsillectomy performed due to suspicion of malignancy, contraindications to post-surgical analgesia protocol.
Outcome results
None listed