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

July 2, 2023 updated by: National Taiwan University Hospital

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.

Study Overview

Detailed Description

The postsurgical adhesions remain a significant cause of morbidity for a large number of patients in thyroid and parathyroid surgeries, despite use of meticulous surgical techniques and regardless of surgical access via conventional open or endoscopy. Such adhesions represent not only adhesion reformation at sites of adhesiolysis, but also de novo adhesion formation at sites of surgical procedures. A number of products, in the form of film or fluid, are used to prevent postoperative adhesion formation. These products normally serve as barriers to separate the contact of the damaged tissue surfaces in many animal models and some clinical practices. However, there are few evidences for surgeons to use or no use, or choose the suitable products in their clinical practice in neck surgeries. 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 . Local tissue inflammation processes initiate capillary leakage of serosanguineous fluid including clotting factors, and recruitment of macrophages and other cells, including fibroblasts. Cutting, fulguration, ligation of the macrovasculature and microvasculature leads to a state of tissue hypoxemia. Along with the accumulation of metabolic byproducts such as lactic acid, the lowering the pH of the injured tissue, and the conversion from aerobic to anaerobic metabolism within the injured tissues. Tissue hypoxia also results in creation of oxidative stress, with production of oxygen and nitrogen free radicals, which can result in DNA mutations, alterations of mitochondrial DNA, and generation of oxidized proteins.

Subsequently induce lipid peroxidation and protein nitration. The known factors involved in the inflammatory-like response that lead to adhesion development, are type 1 collagen, transforming growth factor b1 (TGF-b1), tumor necrosis factor a (TNF-a), interleukin 6 (IL-6), and vascular endothelial growth factor (VEGF). Of note, the scavenging of free radicals such as superoxide by superoxide dismutase can prevent the development of the adhesion phenotype . Other processes affected include plasminogen activator activity (PAA) (a function of tissue plasminogen activator and its inhibitor, plasminogen activator inhibitor-1), metalloproteinase activity, and extracellular matrix deposition (such as collagen 1, collagen 3, and fibronectin). There is also initiation of processes leading to angiogenesis, which can lead to new vessel formation that could resupply oxygen to these tissues as well as remove metabolic byproducts.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Taipei, Taiwan, 100229
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
control group that does not use antiadhesive material
Experimental: Oxidized regenerated cellulose(ORC) Group
The group that uses Oxidized regenerated cellulose(ORC) as antiadhesive material during thyroid surgery.
Investigate the antiadhesive effect of multiple antiadhesive barriers in thyroid surgery
Other Names:
  • Anti-Adhesion Agent
Experimental: Hyaluronic acid(HA) Group
The group that uses Hyaluronic acid(HA) as antiadhesive material during thyroid surgery.
Hyaluronic acid(HA)
Other Names:
  • Anti-Adhesion Agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chinese version of Dysphagia Handicap Index(DHI)
Time Frame: pre-operation
Evaluate the swallowing difficulty
pre-operation
Chinese version of Dysphagia Handicap Index(DHI)
Time Frame: post-operation(week 2)
Evaluate the swallowing difficulty
post-operation(week 2)
Chinese version of Dysphagia Handicap Index(DHI)
Time Frame: post-operation( month1)
Evaluate the swallowing difficulty
post-operation( month1)
Chinese version of Dysphagia Handicap Index(DHI)
Time Frame: post-operation(month 6)
Evaluate the swallowing difficulty
post-operation(month 6)
Chinese version of Dysphagia Handicap Index(DHI)
Time Frame: post-operation( month12)
Evaluate the swallowing difficulty
post-operation( month12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adhesion severity
Time Frame: post-operation(week 2)
Evaluate the adhesion severity by using questionnaires
post-operation(week 2)
Adhesion severity
Time Frame: post-operation(month1)
Evaluate the adhesion severity by using questionnaires
post-operation(month1)
Adhesion severity
Time Frame: post-operation(month 6)
Evaluate the adhesion severity by using questionnaires
post-operation(month 6)
Adhesion severity
Time Frame: post-operation(month12)
Evaluate the adhesion severity by using questionnaires
post-operation(month12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ming Hsun Wu, MD,PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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