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The aim of the present study is to evaluate the prognostic value of intra-operative indocyanine staining scoring concerning 24 hours post-operative PTH levels and the possible advantages that its' use can give in terms of clinical practice compared to conventionally operated patients.
Study objectives are:
The study will be conducted until 60 subjects are included. It is estimated that it will take up to 3 months to enroll the patients.
Pre-Surgery: Procedures preformed such as routine hospital examinations, antibiotic prophylactic treatment, anticoagulant treatment and diet will be according to the standard management protocol and will be recorded for the study. The following pre-surgery information will be recorded:
Intra-operative: The surgeon will perform the preplanned operation. The following intraoperative variables will be recorded for all patients:
Pathology data form: The following pathology data will be recorded for all patients:
1 Postoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | The group will include all adult patients that will sign ICF and will be operated for total thyroidectomy regardless of the undelying disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Drug | Indocyanine green will be administered intravenously to patients enrolled in this study after the completion of total thyroidectomy in order to assess the visibility of parathyroid glands and to assess the possible correlation of ICG score with post-operative parathormone levels in order to predict post-thyroidectomy hypoparathyroidism. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative ICG fluarangiography predicts post-operative PTH values | Whether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| ICG improves the intraoperative recognizability of the parathyroids | To assess the ability of ICG flurangiography to increase recognizability of parathyroid glands during total thyroidectomy based on ICG score of the parathyroids. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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All patients that are going to have a total thyroidectomy regardless of the underlying pathology
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| Name | Affiliation | Role |
|---|---|---|
| Theodosios S Papavramidis, PhD | Assistant Professor of Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece | Thessaloniki | Please Enter the State Or Province | 54655 | Greece |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki | Thessaloniki | 54621 | Greece |