Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT

Not Applicable

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

• Registration Number: NCT04410601
• Lead Sponsor: Umraniye Education and Research Hospital

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.

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 Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-14
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-27
• Last Update Submitted: 2020-05-27
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-01
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dysphagia (the only complication after TT)	Total thyroidectomy	Patients s/p post-thyroidectomy dysphagia only. \*will be enrolled to standard dysphagia-rehabilitation treatment for 6-week.
Dysphagia (with at least one more complication of TT)	Total thyroidectomy	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.
No dysphagia (after total thyroidectomy-TT)	Total thyroidectomy	Patients s/p post-thyroidectomy without complication \*will NOT be enrolled to standard dysphagia-rehabilitation treatment

Primary Outcome Measures

Name	Time	Method
Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)	6 weeks	Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.
Evaluation of Dysphagia- ENT Consultation	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	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-Subjective Survey Form	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)	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Standard Dysphagia Rehabilitation	12 weeks	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?

Trial Locations

Locations (1)

Umraniye Education and Research Hospital, Health Sciences University; 🇹🇷 Istanbul, Turkey