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

Thyroid Cancer Clinical Trial

— Dysphagia-TT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04410601
• Other study ID #: B.10.1.TKH.4.34.H.GP.0.01/173
• Secondary ID: 12.05.2020/173
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2020
• Est. completion date: June 2021

Study information

• Verified date: May 2020
• Source: Umraniye Education and Research Hospital
• Contact: Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS
• Phone: 00 90 (216) 632 1818
• Email: drethemunal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia Comes and Goes
• Dysphagia, Esophageal
• Dysphagia, Oral Phase
• Goiter
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Goiter
• Thyroid Neoplasms
• Thyroid Nodule
• Thyroid Nodule (Benign)
• Thyroiditis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research Hospital, Health Sciences University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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;4 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)	Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.	6 weeks
Secondary	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

External Links

•   Ethem Unal, MD, PhD, ECFMG, IFSO, BCSS, Assoc. Professor of General Surgery & Surgical Oncology, H-index:18 / i10-index:33