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The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions
The objective of this study is to evaluate the efficacy of HANBIO BarriGel in the prevention of postoperative adhesion for patients who will undergo open thyroidectomy. The dysphagia and adhesion severity will be assessed at specific visits pre and/or post-operation for both treatment group and control group. The post-operative condition, and the adverse event information will be collected for evaluation of tolerability and safety of the product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| use HANBIO BarriGel | Experimental |
| |
| No anti-adhesive product | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HANBIO BarriGel | Device | an anti-adhesive product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia Handicap Index (DHI) | Preoperative 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | ||||
| Kaohsiung Veterans General Hospital |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Kaohsiung City |
| Taiwan |
| Keelung Chang Gung Memorial Hospital | Keelung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| D004700 |
| Endocrine System Diseases |