Comparison of QoL for Sutureless Thyroidectomy

Overview

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

Full Title of Study: “Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2016

Detailed Description

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.

Interventions

  • Procedure: Sutureless Thyroidectomy
    • 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.

Arms, Groups and Cohorts

  • Ligasure
    • Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw
  • Harmonic
    • Patients underwent to Sutureless Thyroidectomy with Harmonic FOCUS

Clinical Trial Outcome Measures

Primary Measures

  • Overall alterations in quality of life according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks

Secondary Measures

  • Alterations in social life according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks
  • Alterations in daily life according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks
  • Alterations in Tiredness according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks
  • Alterations in cognitive complaints according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks
  • Alterations in anxiety according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks
  • Alterations in depressivity according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks
  • Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istanbul University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Akif Enes ARIKAN, MD – Istanbul University
  • Overall Official(s)
    • Ates OZYEGIN, Prof, MD, Study Director, Istanbul University, Cerrahpasa Medical Faculty

References

Watt T, Bjorner JB, Groenvold M, Cramon P, Winther KH, Hegedus L, Bonnema SJ, Rasmussen AK, Ware JE Jr, Feldt-Rasmussen U. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Thyroid. 2015 Oct;25(10):1069-79. doi: 10.1089/thy.2015.0209. Epub 2015 Aug 26.

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