An observational study in Thyroidectomy and Quality of Life, sponsored by Istanbul University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Istanbul University · Observational
Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation.
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.
Istanbul University is the lead sponsor of 507 studies on the registry; 80 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who has planned to undergo to sutureless thyroidectomy for benign conditions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw
Procedure: Sutureless Thyroidectomy
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.
Overall alterations in quality of life according to Thy-PRO-39 questionnaire
Time frame: 4 weeks
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
No study locations are listed for this record.
The record gives a start of Jan 2016, a primary completion of May 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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