An interventional study of Total thyroidectomy in Dysphagia, Esophageal, Dysphagia, Oral Phase and Dysphagia Comes and Goes, sponsored by Umraniye Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2020-06-01.
Sponsored by Umraniye Education and Research Hospital · Not applicable, Interventional, and Diagnostic
The most common and feared complications of total thyroidectomy are vocal cord paralyses and hypocalcemia. However, post-thyroidectomy dysphagia is not uncommon and has important consequences on the quality of life (QoL). It should be taken seriously by all clinicians.
Dysphagia is a possible complication that can be observed in patients undergoing thyroidectomy, and can be related to superior and inferior laryngeal nerves dysfunction, but it usually appears after an uncomplicated surgical procedure. Aerodigestive symptoms, such as discomfort, tightness, lump, foreign body, difficulty or pain during swallowin, can also present before operation. If it appears or aggrevates after surgery, laryngeal nerve damage (superior laryngeal nerve - SLN, or inferior laryngeal nerve - recurrent, RLN), tracheo-malacia and postoperative fibrotic changes should be interrogated. However, in most of the cases, an anatomic and/or physiologic defect in the oro-pharngeal region is not easy to be detected. Therefore, a subjective feeling of dysphagia is more common.
Dysphagia has important consequences on the QoL in postoperative period, and should be addressed by the primary surgeon/clinician, regardless of whether it is objective or subjective.
The goal of the present study is to better understand the incidence of postoperative dysphagia symptoms among patients who have undergone total thyroidectomy for benign or malign thyroid disease. Besides, all possible risk factors (pre-intra-post-operative) are also going to be evaluated in detail, and the efficacy of a 6-week dysphagia-rehabilitation programme will also be employed and results will be shared.
Exclusion Criteria:
Patients s/p post-thyroidectomy without complication \*will NOT be enrolled to standard dysphagia-rehabilitation treatment
Procedure: Total thyroidectomy
Patients s/p post-thyroidectomy with both dysphagia and other documented TT complication such as vocal cord paralysis/hypocalcemia/surgical site infection etc. \*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.
Procedure: Total thyroidectomy
Patients s/p post-thyroidectomy dysphagia only. \*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.
Procedure: Total thyroidectomy
DRT-diet modification, compensation strategies, oral motor exercises such as laryngeal elevation, masseters / tongue hold / exercise, bolus transition exercise; chin-down/up, head rotation, and other maneuvers with tactile stimulation.
Also known as: Dysphagia rehabilitation treatment (DRT) programme
Evaluation of Dysphagia-Subjective Survey Form
Subjective survey form to be filled- a self-evaluation questionnaire-to evaluate 'Change from baseline postoperative (po) day 1-3 to week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control. assessing common dysphagia symptoms- includes 6 items scored within a range of 0 (without swallowing alterations) to 24 (maximum swallowing dysfunction).
Time frame: 12 months
Evaluation of Dysphagia-Objective Functional Outcome Swallowing Score (FOSS)
Objective survey form to be filled- a clinician-oriented questionnaire assessing the swallowing function objectively, from stage I (normal function) to stage V (no oral intake). To evaluate change in dysphagia from baseline po day 1-3 to .po week 2, po week 6, po week 16, po week 24, po week 36 and po week 48 (last). A new form will be filled in for each outpatient clinic control.
Time frame: 12 months
Evaluation of Dysphagia- ENT Consultation
Flexible fiberoptic laryngoscopy (any anatomic explanation for dysphagia? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).
Time frame: 12 months
Evaluation of Dysphagia- Neurology Consultation
EMG-electromyography test (any anatomic and/or physiologic dysfunction? YES or NO? To evaluate change in dysphagia from baseline at postoperative (po) week 6 to po week 24, po week 48 (last).
Time frame: 12 months
Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.
Time frame: 6 weeks
Evaluation of Standard Dysphagia Rehabilitation
6-week treatment, starting from po week 6, for all patients with dysphagia- ending at po week 12. Any improvement after 6-week treatment? evaluate at po week 12 and please answer: Any improvent in dysphagia symptom? -YES or NO?
Time frame: 12 weeks
Plan to share: Yes — Excel documents including data (patient ID and protocol # will be shaded) available upon request
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Umraniye Education and Research Hospital