A multi-center, randomized, parallel, assessor-blind, non-inferiority, prospective clinical trial to evaluate the efficacy and safety of PEO GUARD in patients after total Thyroidectomy
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007896
- Lead Sponsor
- Pusan National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 176
1) A person who signs or seals the written consent of the test subject to participation in the study;
2) Men or women over 20 years of age who are eligible to participate during the clinical trial
3) A person who has no clinically significant abnormal findings in a preoperative laboratory examination
4) A person who is scheduled to operate on a thyroidectomy
1) Patients who have participated in other clinical trials and received medication or medical treatment within one month prior to enrollment in this clinical trial
2) A person who has a history of surgery in the same area
3) If you receive anticoagulant therapy or systemic steroid therapy within one week of the treatment date
4) If you have an immunosuppressive or autoimmune disease
5) If you are allergic to substances used in clinical trials
6) Those who have infections in the whole body and surgical areas
7) Patients with serious conditions (e.g., heart failure, kidney failure, liver failure, uncontrolled blood pressure, diabetes, blood clotting disorder, etc.) that the tester believes may affect surgery
8) A person who takes (or is scheduled to) a combination of prohibited substances
9) Alcohol or drug addiction, psychotic
10) Pregnant women, lactating women, and patients who are planning to conceive during this clinical trial or have self-reproducing ability to disagree with contraception cannot use recognized contraception during the trial period (accredited contraception refers to hepatic wall infertility surgery, oral contraception, etc
11) A person who has a history of esophageal-related diseases
12) Those who are expected to be keloids in the wound healing process
13) Other persons who are deemed difficult to perform this clinical trial when judged by the tester
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Marshmallow sikttongjoyeongsul the normal rate of esophageal motor skills through.;Score of esophageal motility through esophageal angiography of marshmallow;Changes in clinical symptoms through a questionnaire (Voice, Swallowing Score) completed by the test subject at 2 weeks and 8 weeks after surgery compared to preoperative surgery
- Secondary Outcome Measures
Name Time Method Voice Disorder Questionnaire;Swallowing Disorder Questionnaire