Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid or Parathyroid Surgery

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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