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Comparison of QoL for Sutureless Thyroidectomy

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ClinicalTrials.gov Identifier: NCT02683551
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Akif Enes ARIKAN, Istanbul University

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

Condition or disease Intervention/treatment
Thyroidectomy Quality of Life Procedure: Sutureless Thyroidectomy

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.

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Study Type : Observational
Actual Enrollment : 193 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Group/Cohort Intervention/treatment
Ligasure
Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw
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.

Harmonic
Patients underwent to Sutureless Thyroidectomy with Harmonic FOCUS
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.




Primary Outcome Measures :
  1. Overall alterations in quality of life according to Thy-PRO-39 questionnaire [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who has planned to undergo to sutureless thyroidectomy for benign conditions.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683551


Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Ates OZYEGIN, Prof, MD Istanbul University, Cerrahpasa Medical Faculty
Additional Information:
Publications:
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Responsible Party: Akif Enes ARIKAN, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT02683551    
Other Study ID Numbers: IUCTF-EndSx-2015-01
83045809/604.01/02 ( Other Identifier: Ethical Committee )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020