Tonsillectomy and risk of post-tonsillectomy haemorrhage - a protocol for a randomised clinical trial.

Abstract

Introduction: Tonsillectomy is one of the most common procedures in the ear, nose and throat field, and 7.7% of the Danish population had undergone a tonsillectomy by the age 20 years in 2012. One feared complication is post-tonsillectomy haemorrhage (PTH), which in a Danish register-based study was found to increase from 3% in 1991 to 13% in 2012. PTH represents a significant risk and deaths are reported in the literature. The aim of the trial is to compare hot and cold haemostasis during tonsillectomy and assess, firstly, the risk of PTH and, secondly, the reported pain perception.

Methods: This is a single-centre, two-arm, interventional randomised controlled trial. The study targets patients > 12 years of age referred for tonsillectomy. Participants will have both tonsils removed; on one side cold haemostasis will be performed and on the other hot diathermia will secure haemostasis. The participants will subsequently receive three questionnaires in the course of a month concerning bleeding episodes and pain perception. Owing to the study design, patients and surgeons act as their own controls.

Conclusions: The results of the study may guide future research and practice of tonsillectomy to reduce the risk of PTH.

Funding: Lizzi and Mogens Staal Fonden and Nordsjællands Hospital. The funding sources had no influence on trial design, data collection, analysis or publication.

Trial registration:

Clinicaltrials: gov Identifier: NCT05161754. Registration date: 20042021; version 2: 20042021.