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.

Three-dimensional soft tissue changes in orthodontic extraction and non-extraction patients: A prospective study.

OBJECTIVES: To assess the soft tissue changes in orthodontic extraction and non-extraction patients on 3D stereophotogrammetric images. SETTING AND SAMPLE: 23 extraction (22.2 ± 9.2 years) and 23 non-extraction (20.3 ± 11.1 years) consecutive patients were enrolled at the Sections of Orthodontics at Aarhus University and at University of Naples Federico II. METHODS: All patients had a first 3D image taken after bonding of brackets on the upper incisors (T0), and a second 3D image (T1) after space closure in the extraction group or at insertion of the first SS or TMA rectangular wire in the non-extraction group. The 3D images were captured with 3dMDFace System and analysed with 3dMDVultus Software. After placing 19 landmarks, 15 measurements were obtained. Intragroup changes were analysed with paired t-test and intergroup changes with unpaired t-test (P < .05). RESULTS: Superimpositions of the 3D images at T0 and T1 visualized with colour-coded maps showed that soft tissue changes primarily happened in the perioral area in both groups. The Nasolabial angle increased significantly in the extraction group (3°± 4.1, P = .002), while it decreased in the non-extraction group (-1.5°± 5.5°, P = .002). There was a significant difference between the two groups (4.4°, P = .004). CONCLUSIONS: 3D comparison of the soft tissues in the extraction and non-extraction groups showed statistically significant, but clinically limited differences in the perioral area. The Nasolabial angle was significantly larger at T1 in the extraction group compared with the non-extraction group.

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.