NIFTy - Observational Study
Research type
Research Study
Full title
Near Infrared Fluorescence (NIRF) Imaging to prevent Post-surgical Hypoparathyroidism (PoSH) after Thyroid Surgery (NIFTy) – preparatory qualitative work prior to a phase II/III pragmatic, multicentre randomised controlled trial
IRAS ID
271152
Contact name
Saba Prakash Balasubramanian
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Parathyroid glands are tiny glands in the neck behind the thyroid gland that control the level of calcium in the blood. More than 12,000 patients undergo thyroid surgery every year in England, and a common problem is damage to or accidental removal of parathyroid glands. This causes a condition called hypoparathyroidism; this may be a temporary condition, but in up to 12% of cases, it is long-term requiring lifelong medication and care.
A new technology called ‘fluorescent imaging’ (NIRF) may help with the identification and preservation of parathyroid glands during thyroid surgery.In the NHS, fluorescent imaging is not used in regular practice and surgeons can carry out the operation in slightly different ways. This study will observe and gain consensus on how the surgery will be carried out in the trial.With patient permission, the surgeon will use fluorescent imaging during the patients surgery to highlight the para-thyroid glands. Researchers will observe and video-record these surgeries (up to 15) so we can identify and describe key components of a thyroidectomy, and observe how surgeons choose to use the fluorescent imaging technology.
We will also interview the surgeon after the operation to find out whether the operation went as expected, and their views of using the imaging device.
The data collected will be used to identify and agree timing and use of fluorescent imaging for a forthcoming randomised controlled trial. We will work with the surgeons to agree which steps of the surgery need to be compulsory or optional, and how and when they will use fluorescence during the operation. We will also develop a questionnaire that can be used in the operating theatre during the forthcoming trial to find out whether using the dye changed what the surgeon did in the operation.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0062
Date of REC Opinion
23 Apr 2020
REC opinion
Further Information Favourable Opinion