Comparison of QoL for Sutureless Thyroidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

193 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Thyroidectomy Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ligasure

Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw

Sutureless Thyroidectomy

Intervention Type PROCEDURE

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

Sutureless Thyroidectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No