Maschuw 2012.
Trial name or title | Total versus near‐total thyroidectomy in Graves' disease and their outcome on postoperative transient hypoparathyroidism: study protocol for a randomised controlled trial |
Methods |
Type of study: randomised controlled clinical trial Allocation: 1:1 Intervention model: parallel group superiority Masking: blinding of patients and observer Primary purpose: to compare rates of transient postoperative hypoparathyroidism in total and subtotal thyroidectomy |
Participants |
Condition: Graves' disease, for definite surgery Inclusion criteria: diagnosis of Graves disease and informed consent to study Exclusion criteria: conservative treatment, malignancy, previous thyroid surgery, coincident hypoparathyroidism |
Interventions |
Intervention: bilateral subtotal thyroidectomy, remnants of < 1mL on each side Control: total thyroidectomy |
Outcomes |
Primary outcome: transient postoperative hypoparathyroidism Secondary outcomes: reoperations due to bleeding, recurrent laryngeal nerve palsy, permanent hypoparathyroidism, recurrent disease, changes of endocrine orbitopathy, quality of life within a one‐year of follow‐up period |
Starting date | Recruitment not started |
Contact information | maschuw@med.uni‐marburg.de |
Study identifier | German clinical trials register (DRKS) DRKS00004161 |
Official title | Total versus near‐total thyroidectomy in Graves' disease and their outcome on postoperative transient hypoparathyroidism: study protocol for a randomised controlled trial |
Stated purpose of study | The trial is designed as a prospective randomised controlled patient and observer blinded multi‐centred trial in a parallel design including an active comparator and an intervention group. The intervention addresses the surgical procedure: near‐total thyroidectomy leaving bilateral remnants of <= 1 mL on each side in the intervention group and total thyroidectomy in the control group. The occurrence of transient postoperative hypoparathyroidism is defined as primary endpoint |
Notes |