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OpenTrials
Completed

NCT Number: NCT02683551

Comparison of QoL for Sutureless Thyroidectomy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sutureless Thyroidectomy

Procedure

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.

Primary outcomes

  1. Overall alterations in quality of life according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

Secondary outcomes

  1. Alterations in social life according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

  2. Alterations in daily life according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

  3. Alterations in Tiredness according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

  4. Alterations in cognitive complaints according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

  5. Alterations in anxiety according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

  6. Alterations in depressivity according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

  7. Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2016
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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