Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT
NCT ID: NCT04410601
Last Updated: 2020-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2020-05-14
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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No dysphagia (after total thyroidectomy-TT)
Patients s/p post-thyroidectomy without complication
\*will NOT be enrolled to standard dysphagia-rehabilitation treatment
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.
Dysphagia (with at least one more complication of TT)
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.
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.
Dysphagia (the only complication after TT)
Patients s/p post-thyroidectomy dysphagia only.
\*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with total thyroidectomy (TT) indication
* Patients over 17 year-old
Exclusion Criteria
* Patients with thyroid disorder, but prepared for surgery other than TT
* Healthy volunteers
* Patients below 17 y/o
17 Years
ALL
No
Sponsors
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Umraniye Education and Research Hospital
OTHER_GOV
Responsible Party
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Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
Associated Professor of General Surgery and Surgical Oncology
Principal Investigators
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Sema YUKSEKDAG, MD
Role: PRINCIPAL_INVESTIGATOR
Instructor in General Surgery
Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS
Role: STUDY_CHAIR
Assoc. Professor of General Surgery and Surgical Oncology
Locations
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Umraniye Education and Research Hospital, Health Sciences University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS
Role: CONTACT
Facility Contacts
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Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS
Role: primary
References
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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.
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.
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.
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.
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.
Related Links
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Ethem Unal, MD, PhD, ECFMG, IFSO, BCSS, Assoc. Professor of General Surgery \& Surgical Oncology, H-index:18 / i10-index:33
Other Identifiers
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12.05.2020/173
Identifier Type: REGISTRY
Identifier Source: secondary_id
B.10.1.TKH.4.34.H.GP.0.01/173
Identifier Type: -
Identifier Source: org_study_id
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