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Comparison of QoL for Sutureless Thyroidectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02683551
Enrollment
193
Registered
2016-02-17
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Thyroidectomy

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.

Interventions

PROCEDURESutureless 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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall alterations in quality of life according to Thy-PRO-39 questionnaire4 weeks

Secondary

MeasureTime frame
Alterations in daily life according to Thy-PRO-39 questionnaire4 weeks
Alterations in Tiredness according to Thy-PRO-39 questionnaire4 weeks
Alterations in cognitive complaints according to Thy-PRO-39 questionnaire4 weeks
Alterations in social life according to Thy-PRO-39 questionnaire4 weeks
Alterations in depressivity according to Thy-PRO-39 questionnaire4 weeks
Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire4 weeks
Alterations in anxiety according to Thy-PRO-39 questionnaire4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026