Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery

Quality of Life Clinical Trial

Official title:

Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048539
• Other study ID #: HE591505
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2017
• Last updated: March 4, 2017
• Start date: February 6, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2017
• Source: Khon Kaen University
• Contact: Pornthep Kasemsiri, MD
• Email: Pkasemsiri99[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the quality of life of transoral endoscopic thyroidectomy compare with open thyroidectomy, Furthermore, postoperative complication will be assessed, also.

Description:

Regarding type of surgery, doctor will just advice about risk and benefit of any type of surgery. And then patient will select by himself. Patients are not assigned to endoscopic or conventional group.

This study start to enrolled patients after surgery. And the quality of life will be observed at 2, 6 and 12 weeks, respectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient who underwent thyroid lobectomy for benign thyroid nodule less or equal 5 cm

Exclusion Criteria:

• previous neck surgery

• suspected thyroid carcinoma

• patient who failure endoscopic thyroidectomy and change to conventional surgery

Related Conditions & MeSH terms

• Conventional Thyroidectomy
• Quality of Life
• Transoral Endoscopic Thyroidectomy

Intervention

Procedure:
• Transoral endoscopic thyroidectomy
This procedure will remove thyroid lobe through oral vestibule. Aim to avoid scar at anterior neck.

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life after surgery	Quality of life will assessed by Short form health survey 36 and specific questionnaire for thyroidectomy. These questionnaires will assess at 2,6 and 12 weeks after surgery. The quality of life results (6 and 12 weeks) will be observed that change from 2 weeks after surgery. Furthermore, investigators will compare score of Short form health survey 36 and specific quality of life questionnaire for thyroidectomy between endoscopic and open technique at 2,6,12 week after surgery, also.	2,6,12 weeks
Secondary	Postoperative complication	The complications will assess at 2,6, and 12 week after surgery.	2,6, and 12 weeks