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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048539
Recruitment Status : Unknown
Verified March 2017 by Pornthep Kasemsiri, Khon Kaen University.
Recruitment status was:  Recruiting
First Posted : February 9, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pornthep Kasemsiri, 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.

Condition or disease Intervention/treatment
Quality of Life Transoral Endoscopic Thyroidectomy Conventional Thyroidectomy Procedure: Transoral endoscopic thyroidectomy

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.

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Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Quality of Life Between Patients Underwent Transoral Endoscopic Thyroid Surgery and Conventional Surgery
Actual Study Start Date : February 6, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
Transoral endoscopic thyroidectomy
Patient who fit with the eligible criteria and choose endoscopic thyroidectomy by himself.
Procedure: Transoral endoscopic thyroidectomy
This procedure will remove thyroid lobe through oral vestibule. Aim to avoid scar at anterior neck.

Conventional thyroidectomy
Patient who fit with the eligible criteria and choose conventional thyroidectomy by himself.



Primary Outcome Measures :
  1. Change in quality of life after surgery [ Time Frame: 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 :
  1. Postoperative complication [ Time Frame: 2,6, and 12 weeks ]
    The complications will assess at 2,6, and 12 week after surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient who underwent thyroid lobectomy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048539


Contacts
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Contact: Pornthep Kasemsiri, MD Pkasemsiri99@gmail.com
Contact: Srongpaun Trakulkajornsak, MD Srongpaun@hotmail.com

Locations
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Thailand
Khon Kaen University Recruiting
Khon Kaen, Thailand, 40002
Contact: Pornthep Kasemsiri, M.D.       Pkasemsiri99@gmail.com   
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Pornthep Kasemsiri, MD Khon Kaen University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pornthep Kasemsiri, Principal investigator, Khon Kaen University
ClinicalTrials.gov Identifier: NCT03048539    
Other Study ID Numbers: HE591505
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pornthep Kasemsiri, Khon Kaen University:
Endoscopic surgery
Thyroidectomy
Quality of life