Neoplasms

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Thyroiditis

Deglutition Disorders

Goiter

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Patients s/p post-thyroidectomy without complication

\*will NOT be enrolled to standard dysphagia-rehabilitation treatment

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.

Patients s/p post-thyroidectomy dysphagia only.

\*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.

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.

Total thyroidectomy

Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS

Sema YUKSEKDAG, MD

Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS

Kadir M YILDIRAK, MD

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.

Dysphagia among patients who have undergone total hyroidectomy for benign/malign thyroid disease. The preoperative factors (demographics; co-morbidities such as diabetes, multiple sclerosis, Parkinson's; body mass index; routine ear-nose-throat-ENT consultation), operative factors (over-manipulation, injury to larynx/neural plexus, easy/hard tracheal intubation, closure of strap muscles/stay open) and postoperative evaluation 1-No dysphagia, 2-Dysphagia with at least one other complication (nerve injury, hypocalcemia), 3-Dysphagia without any other surgical complications; ENT\&neurology consultations, survey.

THE STUDY IS OPEN TO ALL SURGICAL CLINICS OVER THE WORLD EAGER TO JOIN; EXCEL WITH FORMS TO BE FILLED ARE AVAILABLE, please contact the principle/co-investigators by phone/e-mail.

Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT

Pre-and Post-operative Risk Factors Affecting the Incidence and Severity of Dysphagia Following Total Thyroidectomy: An International Multi-centric Prospective Randomized Controlled Clinical Trial (RCT)

Excel documents including data (patient ID and protocol # will be shaded) available upon request

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).

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.

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).

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).

Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.

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?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT	NCT04410601	Dysphagia, Esop... Dysphagia, Oral... Dysphagia Comes... Thyroiditis Thyroid Cancer Thyroid Neoplas... Thyroid Goiter Thyroid Nodule ...	Total thyroidec...	17 Years -	Umraniye Education and Research Hospital
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT	NCT04410601	Dysphagia, Esop... Dysphagia, Oral... Dysphagia Comes... Thyroiditis Thyroid Cancer Thyroid Neoplas... Thyroid Goiter Thyroid Nodule ...	Total thyroidec...	17 Years -	Umraniye Education and Research Hospital

Spots Global Cancer Trial Database for dysphagia, oral phase