Witte 2000.
| Methods |
Type of study: randomised controlled clinical trial Allocation: 1:1:1 Intervention model: parallel group superiority design (three arms) Masking: no blinding of patients or personnel Primary purpose: treatment of Graves' disease |
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| Participants |
Condition: Graves' disease Enrolment: 150 in total Inclusion criteria: diagnosis of Graves disease + informed consent to study Exclusion criteria: No diagnosis of Graves disease Does not consent to study Not medically fit for surgical management Diagnostic criteria: clinical features of Graves' disease with TSH‐R antibodies and hyperthyroidism |
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| Interventions |
Number of study centres: 1 Treatment before study: preoperative treatment with antithyroid medications, beta‐blockers and thyroid hormone substitution. Titration period: none Intervention(s): total thyroidectomy Comparator(s): Dunhill procedure (total lobectomy + contralateral subtotal thyroidectomy) Bilateral subtotal thyroidectomy |
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| Outcomes |
Primary outcome(s): Graves' ophthalmopathy Postoperative TSH‐R antibody level Secondary outcome(s): RLN palsy Hypoparathyroidism Other outcome(s): Wound complications/infection rate |
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| Study details |
Run‐in period: none Study terminated before regular end (for benefit/because of adverse events): no Study start date: 1993 Study completion date: 1995 |
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| Publication details |
Language of publication: English Funding: not stated Publication status: peer‐reviewed journal, full article |
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| Stated aim for study | We investigated whether total thyroidectomy might be superior to subtotal thyroidectomy (bilateral or unilateral remnants of less than 4 mL) in respect to the adverse effect on immunologic parameters and endocrine orbitopathy | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: "After the patients consented to the prospective randomised trial, 50 were randomised to total thyroidectomy, 50 to unilateral total and contralateral subtotal thyroid resection, and 50 to bilateral subtotal thyroid resection" Comment: randomisation after consent for surgery; method of randomisation not specified |
| Allocation concealment (selection bias) | Unclear risk | Comment: not reported whether allocation concealment took place |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: not stated that surgeons were blinded to group allocation |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quote from publication: "in case of specific technical demands, surgeons were allowed to change to recommended procedure individually for the patient's advantage" Comment: in some cases group allocation changed intra‐operatively for technical reasons |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Quote from publication: "pre‐operative and post operative TSH‐Ab titres were measured"; "All patients were checked by certified ear, nose and throat physicians for recurrent laryngeal nerve paralysis" Comment: thyroid status and calcium status were assessed with standardised referenced assays; recurrent laryngeal nerve status was assessed by ENT specialty review, unclear whether blinded |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Quote from publication: "GO was estimated clinically, using the modified scale system of the American Thyroid Association, by general practitioners, ophthalmologists and by the patients themselves" Comment: Graves' ophthalmopathy was assessed by ophthalmologist and patient; unclear whether blinding took place |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Quote from publication: "the TSH‐R antibodies were preoperatively measured in 128 of the 150 patients... post operative TSH‐R‐Abs were measured in 107 of the 150 patients" Comment: preoperative/postoperative TSH‐R antibodies not measured in 14.7% and 28.7% of participants; GO/TSH‐R antibodies/long term calcium all measured from > 18‐58 months postoperatively |
| Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Quote from publication: "GO was estimated clinically, using the modified scale system of the American thyroid association, by general practitioners, ophthalmologists and by the patients themselves" Comment: all Graves' ophthalmopathy patients underwent a standardised assessment pre‐ and postoperatively using ATA criteria |
| Selective reporting (reporting bias) | Unclear risk | Quote from publication: "the TSH‐R antibodies were preoperatively measured in 128 of the 150 patients... post operative TSH‐R‐Abs were measured in 107 of the 150 patients" Comment: a large number of participants had no assessment of the TSH‐R antibodies postoperatively |
| Other bias | Low risk | Comment: no other risk of bias detected |
ATA: American Thyroid Association; ENT: ear, nose and throat; fT3: free tri‐iodothyronine; fT4: free thyroxine; GO: Graves' opthalmopathy; RLN: recurrent laryngeal nerve; TBII: thyrotropin binding inhibiting immunoglobulins; TFT: thyroid function tests; TRAb: anti‐thyroid receptor antibody; TSH: thyroid‐stimulating hormone; TSH‐R: thyroid‐stimulating hormone receptor