NCT04410601

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 15, 2020

Last Update Submit

May 27, 2020

Conditions

Dysphagia, EsophagealDysphagia, Oral PhaseDysphagia Comes and GoesThyroiditisThyroid CancerThyroid NeoplasmsThyroid GoiterThyroid Nodule (Benign)

Keywords

ThyroidectomyTotal thyroidectomyPost-thyroidectomyPost-thyroidectomy dysphagiaInternationalMulti-centric

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Evaluation of Standard Dysphagia Rehabilitation

    12 weeks

Study Arms (3)

No dysphagia (after total thyroidectomy-TT)

ACTIVE COMPARATOR

Patients s/p post-thyroidectomy without complication \*will NOT be enrolled to standard dysphagia-rehabilitation treatment

Procedure: Total thyroidectomy

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.

Procedure: Total thyroidectomy

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.

Procedure: Total thyroidectomy

Interventions

Total thyroidectomyPROCEDURE

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.

Also known as: Dysphagia rehabilitation treatment (DRT) programme
Dysphagia (the only complication after TT)Dysphagia (with at least one more complication of TT)No dysphagia (after total thyroidectomy-TT)

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital, Health Sciences University

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21140251BACKGROUND

  • 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.

    PMID: 31857976BACKGROUND

  • 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.

    PMID: 26434490BACKGROUND

  • 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.

    PMID: 30067834BACKGROUND

  • 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.

    PMID: 28506421RESULT

Related Links

MeSH Terms

Conditions

Deglutition DisordersThyroiditisThyroid NeoplasmsGoiterThyroid Nodule

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesThyroid DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Officials

  • 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

Central Study Contacts

Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS

CONTACT

00 90 (216) 632 1818drethemunal@gmail.com

Sema YUKSEKDAG, MD

CONTACT

00 90 (216) 632 1818drsemayuksekdag@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor of General Surgery and Surgical Oncology

Study Record Dates

First Submitted

May 15, 2020

First Posted

June 1, 2020

Study Start

May 14, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Excel documents including data (patient ID and protocol # will be shaded) available upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months from the beginning (01.06.2020)
Access Criteria
All surgical clinics/Investigators are WELCOME / INVITED to join this CONSORT-compatible RCT
More information

Locations

TU(1)