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Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:
Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.
Patients referred for hemithyroidectomy will be randomized to either:
(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (A): NIRAF-assisted surgery | Experimental | Patients undergoing NIRAF-assisted hemithyroidectomy |
|
| (B): Conventional surgery | Active Comparator | Patients undergoing conventional hemithyroidectomy without NIRAF-assistance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluobeam LX | Device | See arm description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroid gland identification rate | Will be assessed at the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of inadvertent parathyroid excision | Will be assessed one month following surgery | |
| Rate of autotransplantation | Will be assessed at the time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Regional Hospital West Jutland | Holstebro | 7500 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38573333 | Derived | Abood A, Rolighed L, Ovesen T, Madsen SH, Vestergaard P, Triponez F. Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae075. doi: 10.1093/bjs/znae075. |
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Randomized Clinical Trial
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Patients and related health care staff will be blinded for the allocated intervention until the day of surgery
| Conventional surgery without NIRAF assistance |
| Other |
Patients undergoing conventional hemithyroidectomy without NIRAF-assistance |
|