Clinical trial · Interventional
Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.
NCT04853680CI-TRIAL-00053518unknownN/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)
To determine whether the use of anti-adhesion barrier after thyroid surgery can prevent the voice changes after surgery, using objective voice-related indicators.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Nodule | — | UNRESOLVED | — |
| Voice Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-adhesion barrier (Collarbarrier) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Use of Anti-adhesion barrier on the thyroidectomy space. After the thyroidectomy, anti-adhesion barrier will be applied on the thyroidectomy space, around the trachea, cricothyroid muscle and platysma muscle before the closure of surgical wound.
- interventionNames
- Device: Anti-adhesion barrier (Collarbarrier)
- type
- NO_INTERVENTION
- label
- Control
- description
- No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.
Primary outcomes (3)
- measure
- Voice Handicap Index - 30 (VHI-30)
- timeFrame
- Preoperative 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing open thyroidectomy for thyroid cancer * Patients whose tumor size is less than 4cm * Patients who are not suspected of surrounding organ involvement (T4) or metastasis to central lymph nodes in preoperative imaging * Patients with no history of voice-related diseases prior to surgery * Patients with normal movement of both vocal cords in the preoperative vocal cord examination * Patients who consented to the study and obtained consent for the study Exclusion Criteria: * Patients with uncontrolled high blood pressure, diabetes, chronic renal failure, coagulation disease, etc. * History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.) * Medical history of drug or substance disorder (alcohol, etc.) * Patients with diseases related to airways, esophagus, and vocal cords (vocal palsy, vocal cord polyps, etc.) * Patients who have already had adhesions in the foreground due to radiation therapy or surgery on the foreground in the past. * Patients with a history of keloid or hypertrophic scars * Patients planning to perform lateral cervical lymph node dissection * Patients with medical thyroid disease, such as Graves' disease and thyroid inflammation in need of treatment * Pregnant or lactating female patients * Other patients who are in charge of clinical trials as unsuitable for participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.