Adhesion, Thyroidectomy
Conditions
Brief summary
One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of Thermo-sensitive Adhesion Barrier (MEDICLORE) to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.
Interventions
COMBINATION_PRODUCTMEDICLORE
use MEDICLORE at the end of surgery as antiadhesive product
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* planned to perform thyroidectomy due to thyroid nodule * no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer * normal preoperative vocal cord movement * normal preoperative laboratory study
Exclusion criteria
* uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy * history of keloid or hypertrophic scar * Graves disease or hashimoto thyroiditis patients * aspirin or anticoagulant medication within 7 days * radiation exposure to the head and neck * previous operation to the neck * history of allergic reaction to drugs * pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied. | Participants will be followed from the operation to postoperative 2weeks, 3months, 6months |
Countries
South Korea
Outcome results
None listed