Comparison of QoL for Sutureless Thyroidectomy

April 7, 2024 updated by: Akif Enes ARIKAN, Istanbul University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who has planned to undergo to sutureless thyroidectomy for benign conditions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ligasure
Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw
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.
Harmonic
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall alterations in quality of life according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Alterations in social life according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks
Alterations in daily life according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks
Alterations in Tiredness according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks
Alterations in cognitive complaints according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks
Alterations in anxiety according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks
Alterations in depressivity according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks
Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Ates OZYEGIN, Prof, MD, Istanbul University, Cerrahpasa Medical Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 24, 2015

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimated)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IUCTF-EndSx-2015-01
  • 83045809/604.01/02 (Other Identifier: Ethical Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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