Comparison of QoL for Sutureless Thyroidectomy

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683551
• Other study ID #: IUCTF-EndSx-2015-01
• Secondary ID: 83045809/604.01/
• Status: Completed
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: April 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Thyroidectomy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall alterations in quality of life according to Thy-PRO-39 questionnaire		4 weeks
Secondary	Alterations in social life according to Thy-PRO-39 questionnaire		4 weeks
Secondary	Alterations in daily life according to Thy-PRO-39 questionnaire		4 weeks
Secondary	Alterations in Tiredness according to Thy-PRO-39 questionnaire		4 weeks
Secondary	Alterations in cognitive complaints according to Thy-PRO-39 questionnaire		4 weeks
Secondary	Alterations in anxiety according to Thy-PRO-39 questionnaire		4 weeks
Secondary	Alterations in depressivity according to Thy-PRO-39 questionnaire		4 weeks
Secondary	Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire		4 weeks