NCT04410601

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Umraniye Education and Research Hospital · Other Government
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

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
• Thyroid Goiter
• Thyroid Nodule (Benign)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-14
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-06-01
• Last updated: 2020-06-01

Locations

1 site across 1 country: Turkey (Türkiye)