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| ID | Type | Description | Link |
|---|---|---|---|
| 12.05.2020/173 | Registry Identifier | SBU-UmraniyeERH-Ethics Committee-approved RCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No dysphagia (after total thyroidectomy-TT) | Active Comparator | Patients s/p post-thyroidectomy without complication *will NOT be enrolled to standard dysphagia-rehabilitation treatment |
|
| Dysphagia (with at least one more complication of TT) | Experimental | 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. |
|
| Dysphagia (the only complication after TT) | Experimental | Patients s/p post-thyroidectomy dysphagia only. *will be enrolled to standard dysphagia-rehabilitation treatment for 6-week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total thyroidectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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). | 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). | 12 months |
| Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD) | Any anatomic defect? EGD will be performed once at Postoperative (po) week 6. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS | Contact | 00 90 (216) 632 1818 | 1951 | drethemunal@gmail.com |
| Sema YUKSEKDAG, MD | Contact | 00 90 (216) 632 1818 | 19511 | drsemayuksekdag@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sema YUKSEKDAG, MD | Instructor in General Surgery | Principal Investigator |
| Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS | Assoc. Professor of General Surgery and Surgical Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umraniye Education and Research Hospital, Health Sciences University | Recruiting | Istanbul | 34764 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21140251 | Background | Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8. | |
| 31857976 | Background | Hashemian M, Khorasani B, Tarameshlu M, Haghani H, Ghelichi L, Nakhostin Ansari N. Effects of Dysphagia Therapy on Swallowing Dysfunction after Total Thyroidectomy. Iran J Otorhinolaryngol. 2019 Nov;31(107):329-334. doi: 10.22038/ijorl.2019.36233.2193. |
| Label | URL |
|---|---|
| Ethem Unal, MD, PhD, ECFMG, IFSO, BCSS, Assoc. Professor of General Surgery \& Surgical Oncology, H-index:18 / i10-index:33 | View source |
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Excel documents including data (patient ID and protocol # will be shaded) available upon request
6 months from the beginning (01.06.2020)
All surgical clinics/Investigators are WELCOME / INVITED to join this CONSORT-compatible RCT
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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.
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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.
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| 26434490 | Background | Exarchos ST, Lachanas VA, Tsiouvaka S, Tsea M, Hajiioannou JK, Skoulakis CE, Bizakis JG. The impact of perioperative dexamethasone on swallowing impairment score after thyroidectomy: a retrospective study of 118 total thyroidectomies. Clin Otolaryngol. 2016 Oct;41(5):615-8. doi: 10.1111/coa.12547. Epub 2016 Feb 8. No abstract available. |
| 30067834 | Background | Shimizu M, Kobayashi T, Jimbo S, Senoo I, Ito H. Clinical evaluation of surgery for osteophyte-associated dysphagia using the functional outcome swallowing scale. PLoS One. 2018 Aug 1;13(8):e0201559. doi: 10.1371/journal.pone.0201559. eCollection 2018. |
| 28506421 | Result | Scerrino G, Tudisca C, Bonventre S, Raspanti C, Picone D, Porrello C, Paladino NC, Vernuccio F, Cupido F, Cocorullo G, Lo Re G, Gulotta G. Swallowing disorders after thyroidectomy: What we know and where we are. A systematic review. Int J Surg. 2017 May;41 Suppl 1:S94-S102. doi: 10.1016/j.ijsu.2017.03.078. |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D013966 | Thyroiditis |
| D013964 | Thyroid Neoplasms |
| D006042 | Goiter |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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