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

Umraniye Education and Research Hospital

Status: Unknown

Conditions: Dysphagia Comes and Goes; Dysphagia, Oral Phase; Thyroid Goiter; Thyroiditis; Thyroid Nodule (Benign); Thyroid Neoplasms; Thyroid Cancer; Dysphagia, Esophageal

Treatments: Procedure: Total thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04410601

B.10.1.TKH.4.34.H.GP.0.01/173

12.05.2020/173 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 3 patient groups

No dysphagia (after total thyroidectomy-TT)

Active Comparator group

Description:

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

Treatment:

Procedure: Total thyroidectomy

Dysphagia (with at least one more complication of TT)

Experimental group

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.

Treatment:

Procedure: Total thyroidectomy

Dysphagia (the only complication after TT)

Experimental group

Description:

Patients s/p post-thyroidectomy dysphagia only. \*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.

Treatment:

Procedure: Total thyroidectomy