RecruitingACTRN12621000537853

The Effect of Coblation vs Bizact Tonsillectomy on Post-Operative Pain: a randomised control trial

Coblation vs Bizact Tonsillectomy for post-operative pain in adults : a randomised control trial


Sponsor

Professor Simon Carney

Enrollment

70 participants

Start Date

Jul 1, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Tonsillectomy — surgical removal of the tonsils — is one of the most commonly performed operations, and it is notoriously painful in adults, often requiring several days away from normal activities. Two newer techniques, Coblation (using radiofrequency energy) and Bizact (using ultrasonic energy), have each been claimed to reduce post-operative pain and bleeding compared to traditional methods, but they have not been directly compared in a rigorous clinical trial. You may be eligible if you are 18 or older, have clinical indications for tonsillectomy due to recurrent tonsillitis, and are able to give informed consent. People with bleeding disorders, significant anaesthetic risks, previous peri-tonsillar abscess, or suspected tonsillar cancer are not eligible. Participants are randomly assigned to one of the two techniques. Pain scores are recorded in the days following surgery using a visual analogue scale, and researchers also track time to return to normal activities, bleeding during and after surgery, and the duration of the operation. The results will help ear, nose, and throat surgeons choose the most effective technique for their patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 meth

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.


Locations(1)

SA, Australia

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