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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03031639
Other study ID # HE591517
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 13, 2017
Est. completion date January 12, 2021

Study information

Verified date February 2021
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The endoscopic thyroidectomy approach is gaining popularity in the surgical field. This registry tries to collect the outcomes including quality of life and complication for both endoscopic and conventional thyroidectomy methods.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date January 12, 2021
Est. primary completion date January 12, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - The patients who underwent thyroidectomy at Khon Kaen University Exclusion Criteria: - None

Study Design


Intervention

Procedure:
Endoscopic approach thyroidectomy
Thyroid surgery using endoscopy.

Locations

Country Name City State
Thailand Department of Otolaryngology, Khonkaen University Muang Khonkaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Piromchai P, Vatanasapt P, Reechaipichitkul W, Phuttharak W, Thanaviratananich S. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study. BMC Ear Nose Throat Disord. 2008 Mar 20;8:1. doi: 10.1186/1472-6815-8-1. — View Citation

Piromchai P, Wijakkanalan P, Teeramatwanich W, Kasemsiri P, Laohasiriwong S, Ratanaanekchai T. Postauricular-submental approach endoscopic thyroidectomy. Clin Otolaryngol. 2018 Apr;43(2):767-769. doi: 10.1111/coa.12791. Epub 2016 Nov 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline of QOL Score at 6 months Validated quality of life score(SF-36) will be measure at baseline and 6 months 6 months
Secondary Change of the symptoms score The questionnaire for pain, numbness, voice, swallowing and neck movement function will be given and the patient needs to rate from 0 to 10. At 2, 6, 12, and 24 weeks after surgery
Secondary Complication rate Complications after surgery At 2, 6, 12, and 24 weeks after surgery
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