Comparison of QoL for Sutureless Thyroidectomy

I

Istanbul University

Status

Completed

Conditions

Quality of Life
Thyroidectomy

Treatments

Procedure: Sutureless Thyroidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT02683551
83045809/604.01/02 (Other Identifier)
IUCTF-EndSx-2015-01

Details and patient eligibility

About

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

Full 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.

Enrollment

193 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

193 participants in 2 patient groups

Ligasure
Description:
Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw
Treatment:
Procedure: Sutureless Thyroidectomy
Harmonic
Description:
Patients underwent to Sutureless Thyroidectomy with Harmonic FOCUS
Treatment:
Procedure: Sutureless Thyroidectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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