Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid Surgery
Post-thyroid Surgery Adhesion Prevention Using Oxidized Regenerated Cellulose and Hyaluronic Acid: Prospective, Single-blinded, Randomized Study
2 other identifiers
interventional
45
1 country
1
Brief Summary
Despite use of meticulous surgical techniques and regardless of surgical access via conventional open or endoscopy, postoperative adhesions develop in the vast majority of patients undergoing neck surgery. Such adhesions represent not only adhesion reformation at sites of adhesiolysis, but also de novo adhesion formation at sites of surgical procedures. Improved understanding of the pathophysiology of adhesion development and distinguishing variations in the molecular biologic mechanisms represent future opportunities to improve the reduction of postoperative adhesions. After surgical tissue injury, there were local release of histamine, cytokines, and growth factors that lead to adhesion development. Other than survival or safety issues, cosmetics concerns and quality of life are the motifs after thyroid surgeries currently. Pos-thyroidectomy adhesions include various symptoms such as neck discomfort, neck tightness, skin adhesion to the trachea, skin scarring from adhesive reaction, and vocal cord palsy or impairment of laryngeal vertical movement. Relief of the adhesion through wound massage or anti-adhesion agents could reduce neck discomfort and voice changes.Although oxidized regenerated cellulose (ORC) and hyaluronic acid (HA) appeared to be safe and effective to decrease the incidence of adhesions, to improve adhesion-related neck discomfort, and to prevent skin adhesion to the trachea after neck surgery. The application of antiadhesive barriers after neck surgery is safe but the effect is still uncertain. Thus, we aim to confirm the antiadhesive effect of multiple antiadhesive barriers in thyroid/parathyroid surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
May 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2025
CompletedSeptember 19, 2025
August 1, 2025
4 months
April 17, 2023
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
pre-operation
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
post-operation(week 2)
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
post-operation( month1)
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
post-operation(month 6)
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
post-operation( month12)
Secondary Outcomes (4)
Adhesion severity
post-operation(week 2)
Adhesion severity
post-operation(month1)
Adhesion severity
post-operation(month 6)
Adhesion severity
post-operation(month12)
Study Arms (3)
Control
NO INTERVENTIONcontrol group that does not use antiadhesive material
Oxidized regenerated cellulose(ORC) Group
EXPERIMENTALThe group that uses Oxidized regenerated cellulose(ORC) as antiadhesive material during thyroid surgery.
Hyaluronic acid(HA) Group
EXPERIMENTALThe group that uses Hyaluronic acid(HA) as antiadhesive material during thyroid surgery.
Interventions
Investigate the antiadhesive effect of multiple antiadhesive barriers in thyroid surgery
Hyaluronic acid(HA)
Eligibility Criteria
You may qualify if:
- Age more than 20 years of age.
- Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection).
- Naïve patients to thyroid surgery.
- Subjects are willing to comply with all aspects of the study and have signed informed consent form.
You may not qualify if:
- Pregnant or lactating female patients.
- Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy.
- Concurrent diseases/conditions which will be unable to evaluate the outcomes.
- Patients with previous neck radiotherapy within 1 year.
- Patients receiving any adhesion prevention adjuvant.
- Previous history of Keloid or hypertrophic scar.
- Participate are hypersensitive to anti-adhesion agents.
- Participate in another clinical trial within 1 month.
- Participate have drug or alcohol abuse.
- Patients' presence of surgical site infection or uncontrolled bleeding.
- Anticoagulant used within a week from surger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100229, Taiwan
Related Publications (1)
Kuo TC, Chen KY, Tsai YJ, Lin MT, Chang CH, Wu MH. Post-thyroid surgery adhesion prevention using oxidized regenerated cellulose and hyaluronic acid: prospective, single-blinded, randomized study. BJS Open. 2025 Jul 1;9(4):zraf079. doi: 10.1093/bjsopen/zraf079.
PMID: 40613790DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ming Hsun Wu
MD，PhD
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2023
First Posted
May 9, 2023
Study Start
May 24, 2023
Primary Completion
September 13, 2023
Study Completion
August 11, 2025
Last Updated
September 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share