Comparison of QoL for Sutureless Thyroidectomy

Study Overview
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Brief Summary
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Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation.

Detailed Description
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Patients who have consent to undergo to total thyroidectomy with sutureless technique (regardless of attending to study or not) for benign thyroid diseases in the institution are asked to participate to this study. Patients are informed that participating to this study will not alter their treatment method. Patients were operated either with Ligasure SmallJaw or Harmonic Focus according to result of label picked from bag. Same surgical team performed all operations and they did not know if the patient was participated in study or not. Patients willing to participate in this study are being questioned for their quality of life (QoL) with a patient-reported outcome (PRO) questionnaire before surgery and 4 weeks after surgery. For assessment of quality of life Thy-PRO-39 questionnaire is being used. Responses of patients to QoL questionnaire is being recorded to a secure online database. After data completion answers of patients will be exported as anonymous to principal investigator for analysis. Effect of two energy based devices (EBD) on QOL will be compared.

Official Title
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Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?

Conditions
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Thyroidectomy, Quality of Life

Intervention / Treatment
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* Procedure: Sutureless Thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sutureless thyroidectomy for benign conditions Exclusion Criteria: Known neck malignity, History of neck operation Ligation use during surgery Refusal of patient Non-capable patient Non-euthyroid patient Pregnancy Having rheumatic diseases Having connective tissue diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ligasure<br>Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw | Procedure: Sutureless Thyroidectomy<br>* Thyroidectomy performed with energy based devices and no use of ligation. Used device is not altered for this study. Non of the personnel in the operating room including surgical team knows if the patient was enrolled or not in this study.<br>|
| Harmonic<br>Patients underwent to Sutureless Thyroidectomy with Harmonic FOCUS | Procedure: Sutureless Thyroidectomy<br>* Thyroidectomy performed with energy based devices and no use of ligation. Used device is not altered for this study. Non of the personnel in the operating room including surgical team knows if the patient was enrolled or not in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall alterations in quality of life according to Thy-PRO-39 questionnaire |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations in social life according to Thy-PRO-39 questionnaire |  | 4 weeks | 
| Alterations in daily life according to Thy-PRO-39 questionnaire |  | 4 weeks | 
| Alterations in Tiredness according to Thy-PRO-39 questionnaire |  | 4 weeks | 
| Alterations in cognitive complaints according to Thy-PRO-39 questionnaire |  | 4 weeks | 
| Alterations in anxiety according to Thy-PRO-39 questionnaire |  | 4 weeks | 
| Alterations in depressivity according to Thy-PRO-39 questionnaire |  | 4 weeks | 
| Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire |  | 4 weeks |