Comparison of QoL for Sutureless Thyroidectomy

Completed

• Conditions: Quality of Life; Thyroidectomy
• Interventions: Procedure: Sutureless Thyroidectomy

• Registration Number: NCT02683551
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study First Submitted: 2015-10-24
• Study Start: 2016-01
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Harmonic	Sutureless Thyroidectomy	Patients underwent to Sutureless Thyroidectomy with Harmonic FOCUS
Ligasure	Sutureless Thyroidectomy	Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw

Primary Outcome Measures

Name	Time	Method
Overall alterations in quality of life according to Thy-PRO-39 questionnaire	4 weeks

Secondary Outcome Measures

Name	Time	Method
Alterations in social life according to Thy-PRO-39 questionnaire	4 weeks
Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire	4 weeks
Alterations in daily life according to Thy-PRO-39 questionnaire	4 weeks
Alterations in cognitive complaints according to Thy-PRO-39 questionnaire	4 weeks
Alterations in anxiety according to Thy-PRO-39 questionnaire	4 weeks
Alterations in depressivity according to Thy-PRO-39 questionnaire	4 weeks
Alterations in Tiredness according to Thy-PRO-39 questionnaire	4 weeks