Dysphagia, EsophagealDysphagia-TTNCT04410601
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT
A study testing Total thyroidectomy in people with Dysphagia, Esophageal and Dysphagia, Oral Phase, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Dysphagia, Esophageal, Dysphagia, Oral Phase, Dysphagia Comes and Goes
- What is being tested?
- Total thyroidectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma)
- Patients with total thyroidectomy (TT) indication
- Patients over 17 year-old
Who cannot join
- Patients without thyroid disease
- Patients with thyroid disorder, but prepared for surgery other than TT
- Healthy volunteers
- Patients below 17 y/o
Trial locations and contacts
1 site in 1 country.
Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Umraniye Education and Research Hospital, Health Sciences University
Istanbul, 34764
Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS, 00 90 (216) 632 1818 ext. 1951, drethemunal@gmail.com
Sema YUKSEKDAG, MD, 00 90 (216) 632 1818 ext. 1951, drsemayuksekdag@gmail.com
About this study
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)
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.
Read the 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.
- Conditions
- Dysphagia, Esophageal, Dysphagia, Oral Phase, Dysphagia Comes and Goes, Thyroiditis, Thyroid Cancer, Thyroid Neoplasms
- Being tested
- Total thyroidectomy
- Keywords
- Thyroidectomy, Total thyroidectomy, Post-thyroidectomy, Post-thyroidectomy dysphagia, International, Multi-centric
- Medical subject headings
- Deglutition Disorders, Thyroiditis, Thyroid Neoplasms, Goiter, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or surgery
Also called Dysphagia rehabilitation treatment (DRT) programme
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.
| Study group | Role | What they receive |
|---|---|---|
| No dysphagia (after total thyroidectomy-TT) | Active comparator | Patients s/p post-thyroidectomy without complication
*will NOT be enrolled to standard dysphagia-rehabilitation treatment Receives: 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. Receives: 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. Receives: Procedure: Total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 months
Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.
Measured: 6 weeks
Secondary outcomes (1)
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?
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start14 May 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, EsophagealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic, Umraniye Education and Research Hospital
- Investigators
- Sema YUKSEKDAG, MD, Principal investigator, Instructor in General SurgeryEthem UNAL, MD, PhD, ECFMG, IFSO & Board CSS, Study chair, Assoc. Professor of General Surgery and Surgical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410601
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/173
- Other IDs
- 12.05.2020/173
- Acronym
- Dysphagia-TT
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Excel documents including data (patient ID and protocol # will be shaded) available upon request
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.
PubMed 21140251Hashemian 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.
PubMed 31857976Exarchos 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.
PubMed 26434490Shimizu 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.
PubMed 30067834Scerrino 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.
PubMed 28506421
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04410601
- Acronym / sponsor ID
- Dysphagia-TT / B.10.1.TKH.4.34.H.GP.0.01/173
- Conditions
- Dysphagia, Esophageal, Dysphagia, Oral Phase, Dysphagia Comes and Goes, Thyroiditis, Thyroid Cancer, Thyroid Neoplasms
- Keywords
- Thyroidectomy, Total thyroidectomy, Post-thyroidectomy, Post-thyroidectomy dysphagia, International, Multi-centric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 14 May 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| No dysphagia (after total thyroidectomy-TT) | Active comparator | Procedure: Total thyroidectomyPatients s/p post-thyroidectomy without complication *will NOT be enrolled to standard dysphagia-rehabilitation treatment |
| Dysphagia (with at least one more complication of TT) | Experimental | Procedure: Total thyroidectomyPatients 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. |
| Dysphagia (the only complication after TT) | Experimental | Procedure: Total thyroidectomyPatients s/p post-thyroidectomy dysphagia only. *will be enrolled to standard dysphagia-rehabilitation treatment for 6-week. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma)
- Patients with total thyroidectomy (TT) indication
- Patients over 17 year-old
Key exclusion criteria (4 listed)
- Patients without thyroid disease
- Patients with thyroid disorder, but prepared for surgery other than TT
- Healthy volunteers
- Patients below 17 y/o
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total thyroidectomyAlso: Dysphagia rehabilitation treatment (DRT) programmeDRT-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. | Procedure or surgery | Dysphagia (the only complication after TT), Dysphagia (with at least one more complication of TT), No dysphagia (after total thyroidectomy-TT) |
Primary outcome
Evaluation of Dysphagia-Subjective Survey Form
Time frame: 12 months
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).
Evaluation of Dysphagia-Objective Functional Outcome Swallowing Score (FOSS)
Time frame: 12 months
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.
Evaluation of Dysphagia- ENT Consultation
Time frame: 12 months
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).
Evaluation of Dysphagia- Neurology Consultation
Time frame: 12 months
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).
Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
Time frame: 6 weeks
Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.
1 secondary outcome
Evaluation of Standard Dysphagia Rehabilitation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Background: PubMed 21140251Rihn 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.
- Background: PubMed 31857976Hashemian 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.
- Background: PubMed 26434490Exarchos 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.
- Background: PubMed 30067834Shimizu 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.
- Results publication: PubMed 28506421Scerrino 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.
- Ethem Unal, MD, PhD, ECFMG, IFSO, BCSS, Assoc. Professor of General Surgery \& Surgical Oncology, H-index:18 / i10-index:33Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Excel documents including data (patient ID and protocol # will be shaded) available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS contact
Sema YUKSEKDAG, MD principal investigator
Instructor in General Surgery
Ethem UNAL, MD, PhD, ECFMG, IFSO & Board CSS study chair
Assoc. Professor of General Surgery and Surgical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total thyroidectomy in people with Dysphagia, Esophageal and Dysphagia, Oral Phase, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ethem UNAL, MD, PhD, USMLE, IFSO & Board CSS (00 90 (216) 632 1818 ext. 1951, drethemunal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Dysphagia-Subjective Survey Form (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410601, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.