Cold steel versus impedance-dependent tissue sealer tonsillectomy - a study protocol for a randomised controlled trial.

INTRODUCTION: Approximately 7,000 tonsillectomies are performed annually in Denmark on a benign basis. The cold steel surgical technique is the gold standard. The risk of post tonsillectomy bleeding (PTH) in a centre in Jutland is 7.9%. A new impedance-dependent tissue sealer (IDTS) device has been developed, with preliminary results showing a reduction in operation time, perioperative bleeding and post-operative risk of bleeding of 4.5%. METHODS: A randomised, controlled, double-blinded multicentre trial of cold steel tonsillectomy versus IDTS will be performed on 1,250 patients. The main endpoint is PTH, perioperative bleeding, operation time and post-operative pain. The secondary outcomes are days until return to work, food intake, activity and quality of life. Included in the study are patients with indication for surgery weighing ≥ 16 kg, and excluded are patients with malignancy, bleeding disorders and unwillingness to participate in the study. CONCLUSIONS: To our knowledge, the present study is the largest randomised controlled trial in ENT surgery in the Nordic countries. The study will potentially provide evidence on PTH regarding two tonsillectomy methods. FUNDING: The authors have no potential conflicts of interest to declare. The study is supplied with instruments from Medtronic needed for the surgical procedures. Furthermore, a minor part of the funding of the entire project is provided by the aforementioned company. The funding providers have no role in design or conduct of the study. CLINICALTRIALS: gov with the identification number NCT05270109.

Crosscultural Adaption and Validation of the Danish Voice Handicap Index-10.

BACKGROUND: The Voice Handicap Index 30 (VHI-30) is a much-used voice specific quality of life questionnaire. A shortened 10 item version has been developed by eliminating redundant items using item analyses. This is the first Danish translation of the VHI-10. OBJECTIVES: To evaluate the psychometric properties of the Danish VHI-10 questionnaire. STUDY DESIGN: Cross-sectional survey study. METHODS: A Danish translation of the VHI-10 was answered by 72 patients with voice disorders of different etiology (neurogenic, functional, and structural) and by a control group of 94 vocally healthy individuals. Thirty-two patients and 68 controls participated in a test-retest reliability analysis. The internal consistency, test-retest reliability, and clinical validity were assessed. RESULTS: Excellent internal consistency was found in the patient group with a Cronbach's α of >0.90. In the control group the internal consistency was good with a Cronbach's α of 0.88. Test-retest reliability was good with intra class correlation coefficient of 0.94 (95% confidence interval [95%CI]: 0.88-0.97) for patients and 0.82 (95%CI: 0.73-0.89) for the control group. This indicates a sufficient reliability of the questionnaire. The correlation between the Danish VHI-10 score and the patient's perception of the severity of the voice disorder was 0.75 (P < 0.001) indicating good clinical validity of the Danish VHI-10. CONCLUSION: The newly translated Danish VHI-10 was validated and performs similar to the original VHI-10. It showed good internal consistency, test-retest reliability, and clinical validity. The questionnaire is preferably for use in patients with moderate to severe voice complaints as its ability to distinguish mild voice changes from healthy voices is limited. However, the questionnaire is capable of assessing patients' perception of the severity of their voice disorder and is available for use in daily practice and in research projects.