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

• Conditions: Quality of Life; Conventional Thyroidectomy; Transoral Endoscopic Thyroidectomy
• Interventions: Procedure: Transoral endoscopic thyroidectomy

• Registration Number: NCT03048539
• Lead Sponsor: Khon Kaen University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-02
• Study Start: 2017-02-06
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-04
• Last Update Posted: 2017-03-07
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transoral endoscopic thyroidectomy	Transoral endoscopic thyroidectomy	Patient who fit with the eligible criteria and choose endoscopic thyroidectomy by himself.

Primary Outcome Measures

Name	Time	Method
Change in quality of life after surgery	2,6,12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative complication	2,6, and 12 weeks	The complications will assess at 2,6, and 12 week after surgery.

Trial Locations

Locations (1)

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand