Clinical trial NCT02683551: Comparison of QoL for Sutureless Thyroidectomy
Official title: Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroidectomy
Quality of Life
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who has planned to undergo to sutureless thyroidectomy for benign conditions.

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

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.

Eligibility 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

Primary outcomes:
measure: Overall alterations in quality of life according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Alterations in social life according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
measure: Alterations in daily life according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
measure: Alterations in Tiredness according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
measure: Alterations in cognitive complaints according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
measure: Alterations in anxiety according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
measure: Alterations in depressivity according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
measure: Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University, Cerrahpasa Medical Faculty
name: Ates OZYEGIN, Prof, MD
role: STUDY_DIRECTOR
References:
citation: 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.