Clinical trial NCT04410601: Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia, Esophageal
Dysphagia, Oral Phase
Dysphagia Comes and Goes
Thyroiditis
Thyroid Cancer
Thyroid Neoplasms
Thyroid Goiter
Thyroid Nodule (Benign)
Keywords: Thyroidectomy
Total thyroidectomy
Post-thyroidectomy
Post-thyroidectomy dysphagia
International
Multi-centric
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-01
Enrollment: 500
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma)
* Patients with total thyroidectomy (TT) indication
* Patients over 17 year-old

Exclusion Criteria:

* Patients without thyroid disease
* Patients with thyroid disorder, but prepared for surgery other than TT
* Healthy volunteers
* Patients below 17 y/o

Primary outcomes:
measure: Evaluation of Dysphagia-Subjective Survey Form
timeFrame: 12 months
measure: Evaluation of Dysphagia-Objective Functional Outcome Swallowing Score (FOSS)
timeFrame: 12 months
measure: Evaluation of Dysphagia- ENT Consultation
timeFrame: 12 months
measure: Evaluation of Dysphagia- Neurology Consultation
timeFrame: 12 months
measure: Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluation of Standard Dysphagia Rehabilitation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital, Health Sciences University
Study officials:
affiliation: Instructor in General Surgery
name: Sema YUKSEKDAG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assoc. Professor of General Surgery and Surgical Oncology
name: Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.