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

Primary Purpose

Thyroidectomy, Goiter, Thyroid Cancer

Status
Recruiting
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Oxidized regenerated cellulose(ORC)
Hyaluronic acid(HA)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroidectomy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Oxidized regenerated cellulose(ORC) Group

Hyaluronic acid(HA) Group

Arm Description

control group that does not use antiadhesive material

The group that uses Oxidized regenerated cellulose(ORC) as antiadhesive material during thyroid surgery.

The group that uses Hyaluronic acid(HA) as antiadhesive material during thyroid surgery.

Outcomes

Primary Outcome Measures

Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty
Chinese version of Dysphagia Handicap Index(DHI)
Evaluate the swallowing difficulty

Secondary Outcome Measures

Adhesion severity
Evaluate the adhesion severity by using questionnaires
Adhesion severity
Evaluate the adhesion severity by using questionnaires
Adhesion severity
Evaluate the adhesion severity by using questionnaires
Adhesion severity
Evaluate the adhesion severity by using questionnaires

Full Information

First Posted
April 17, 2023
Last Updated
July 2, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05851560
Brief Title
Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid or Parathyroid Surgery
Official Title
Prospective Comparison of the Effect on Antiadhesive Barriers During Thyroid or Parathyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Goiter, Thyroid Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
control group that does not use antiadhesive material
Arm Title
Oxidized regenerated cellulose(ORC) Group
Arm Type
Experimental
Arm Description
The group that uses Oxidized regenerated cellulose(ORC) as antiadhesive material during thyroid surgery.
Arm Title
Hyaluronic acid(HA) Group
Arm Type
Experimental
Arm Description
The group that uses Hyaluronic acid(HA) as antiadhesive material during thyroid surgery.
Intervention Type
Drug
Intervention Name(s)
Oxidized regenerated cellulose(ORC)
Other Intervention Name(s)
Anti-Adhesion Agent
Intervention Description
Investigate the antiadhesive effect of multiple antiadhesive barriers in thyroid surgery
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid(HA)
Other Intervention Name(s)
Anti-Adhesion Agent
Intervention Description
Hyaluronic acid(HA)
Primary Outcome Measure Information:
Title
Chinese version of Dysphagia Handicap Index(DHI)
Description
Evaluate the swallowing difficulty
Time Frame
pre-operation
Title
Chinese version of Dysphagia Handicap Index(DHI)
Description
Evaluate the swallowing difficulty
Time Frame
post-operation(week 2)
Title
Chinese version of Dysphagia Handicap Index(DHI)
Description
Evaluate the swallowing difficulty
Time Frame
post-operation( month1)
Title
Chinese version of Dysphagia Handicap Index(DHI)
Description
Evaluate the swallowing difficulty
Time Frame
post-operation(month 6)
Title
Chinese version of Dysphagia Handicap Index(DHI)
Description
Evaluate the swallowing difficulty
Time Frame
post-operation( month12)
Secondary Outcome Measure Information:
Title
Adhesion severity
Description
Evaluate the adhesion severity by using questionnaires
Time Frame
post-operation(week 2)
Title
Adhesion severity
Description
Evaluate the adhesion severity by using questionnaires
Time Frame
post-operation(month1)
Title
Adhesion severity
Description
Evaluate the adhesion severity by using questionnaires
Time Frame
post-operation(month 6)
Title
Adhesion severity
Description
Evaluate the adhesion severity by using questionnaires
Time Frame
post-operation(month12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting-Chun Kuo
Phone
+88623123456
Ext
62557
Email
tinakuo1204@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Hsun Wu
Phone
+88623123456
Ext
71519
Email
dtsurgp9@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hsun Wu
Organizational Affiliation
MD,PhD
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100229
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Hsun Wu
Phone
+886-2312-3456
Ext
71519
Email
dtsurg9@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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