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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dysphagia, Esophageal
- Sponsor
- Umraniye Education and Research Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
- Last Updated
- 5 years ago
Overview
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.
Investigators
Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
Associated Professor of General Surgery and Surgical Oncology
Umraniye Education and Research Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluation of Dysphagia- Esophago-gastro-duodenoscopy (EGD)
Time Frame: 6 weeks
Any anatomic defect? EGD will be performed once at Postoperative (po) week 6.
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-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.
Secondary Outcomes
- Evaluation of Standard Dysphagia Rehabilitation(12 weeks)