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. 2015 Nov 25;2015(11):CD010576. doi: 10.1002/14651858.CD010576.pub2

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
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