Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT (Dysphagia-TT)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Thyroid Neoplasms; Thyroid Cancer; Thyroiditis; Thyroid Goiter; Dysphagia, Oral Phase; Dysphagia, Esophageal; Dysphagia Comes and Goes; Thyroid Nodule (Benign)
• Intervention / Treatment: Procedure: Total thyroidectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS; Phone Number: 1951 00 90 (216) 632 1818; Email: drethemunal@gmail.com
• Study Contact Backup: Name: Sema YUKSEKDAG, MD; Phone Number: 19511 00 90 (216) 632 1818; Email: drsemayuksekdag@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34764
    • Recruiting
    • Umraniye Education and Research Hospital, Health Sciences University
    • Contact: Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS; Phone Number: 1951 00 90 (216) 632 1818; Email: drethemunal@gmail.com
    • Contact: Sema YUKSEKDAG, MD; Phone Number: 1951 00 90 (216) 632 1818; Email: drsemayuksekdag@gmail.com
    • Sub-Investigator: Kadir M YILDIRAK, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No dysphagia (after total thyroidectomy-TT); Patients s/p post-thyroidectomy without complication *will NOT be enrolled to standard dysphagia-rehabilitation treatment	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.; Other Names: Dysphagia rehabilitation treatment (DRT) programme
Experimental: 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.	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.; Other Names: Dysphagia rehabilitation treatment (DRT) programme
Experimental: Dysphagia (the only complication after TT); Patients s/p post-thyroidectomy dysphagia only. *will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.	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.; Other Names: Dysphagia rehabilitation treatment (DRT) programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital
• Investigators: Study Chair: Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS, Assoc. Professor of General Surgery and Surgical Oncology

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: International; Thyroidectomy; Total thyroidectomy; Post-thyroidectomy; Post-thyroidectomy dysphagia; Multi-centric
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Thyroid Diseases; Deglutition Disorders; Thyroid Neoplasms; Goiter; Thyroid Nodule; Thyroiditis
• Other Study ID Numbers: B.10.1.TKH.4.34.H.GP.0.01/173; 12.05.2020/173 (Registry Identifier: SBU-UmraniyeERH-Ethics Committee-approved RCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Excel documents including data (patient ID and protocol # will be shaded) available upon request
• IPD Sharing Time Frame: 6 months from the beginning (01.06.2020)
• IPD Sharing Access Criteria: All surgical clinics/Investigators are WELCOME / INVITED to join this CONSORT-compatible RCT
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No