Clinical trial · Interventional
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT
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)
NCT04410601CI-TRIAL-00045340Dysphagia-TTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia Comes and Goes | — | UNRESOLVED | — |
| Dysphagia, Esophageal | — | UNRESOLVED | — |
| Dysphagia, Oral Phase | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Goiter | — | UNRESOLVED | — |
| Thyroiditis | — | UNRESOLVED | — |
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
| Thyroid Nodule (Benign) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total thyroidectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- No dysphagia (after total thyroidectomy-TT)
- description
- Patients s/p post-thyroidectomy without complication \*will NOT be enrolled to standard dysphagia-rehabilitation treatment
- interventionNames
- Procedure: Total thyroidectomy
- type
- EXPERIMENTAL
- label
- Dysphagia (with at least one more complication of TT)
- description
- 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.
- interventionNames
- Procedure: Total thyroidectomy
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDRihn 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 21140251
- BACKGROUNDHashemian 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 31857976
- BACKGROUNDExarchos 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 26434490
- BACKGROUNDShimizu 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 30067834
- RESULTScerrino 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 28506421