NCT03510143

Brief Summary

This study is a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

March 20, 2018

Last Update Submit

April 25, 2018

Conditions

Thyroid Gland CarcinomaThyroid CancerThoracic Duct Leak

Keywords

thyroid cancerNeoveilseromachyle leakage

Outcome Measures

Primary Outcomes (1)

  • Change of triglyceride(TG) level in drained fluid

    Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL

    Change from drain TG level from postoperative 1st day to postoperative 2nd day

Secondary Outcomes (1)

  • Drain amount

    Postoperative 1st and 2nd days

Study Arms (2)

Control

NO INTERVENTION

No use of Neoveil in the neck node dissection area

Neoveil

EXPERIMENTAL

Use of Neoveil in the neck node dissection area

Device: Neoveil (Polyglycolic Acid Mesh)

Interventions

Neoveil (Polyglycolic Acid Mesh)DEVICE

Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.

Neoveil

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are between 20 and 70 years of age
  • Patients who agreed to the study
  • Patients undergoing thyroidectomy and cervical node dissection for thyroid cancer
  • Patients without perithyroidal organ infiltration or distant metastasis
  • Before the operation, bilateral vocal cord movement was normal
  • Patients without significant abnormal findings in laboratory tests before surgery

You may not qualify if:

  • Patients judged to be inadequate by the person in charge of clinical trial
  • Aspirin, anti-platelet medication within 7 days of admission
  • Uncontrolled hypertension, diabetes, chronic renal failure, coagulation disorders
  • Cardiovascular disease (angina, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
  • Drug abuse and alcohol abuse
  • History of esophagus and airway diseases
  • Patients who participated in other clinical trials within 30 days
  • Patients who had previous history of neck irradiation or neck surgery
  • Patients with a history of allergy to drugs
  • For women, pregnant and lactating patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin Wook Yi

Seoul, 03080, South Korea

Location

Related Publications (3)

  • Jang JY, Shin YC, Han Y, Park JS, Han HS, Hwang HK, Yoon DS, Kim JK, Yoon YS, Hwang DW, Kang CM, Lee WJ, Heo JS, Kang MJ, Chang YR, Chang J, Jung W, Kim SW. Effect of Polyglycolic Acid Mesh for Prevention of Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial. JAMA Surg. 2017 Feb 1;152(2):150-155. doi: 10.1001/jamasurg.2016.3644.

    PMID: 27784046RESULT

  • Kuwata T, Shinohara S, Takenaka M, Oka S, Chikaishi Y, Hirai A, Kuroda K, So T, Tanaka F. The impact of covering the bulla with an absorbable polyglycolic acid (PGA) sheet during pneumothorax surgery. Gen Thorac Cardiovasc Surg. 2016 Sep;64(9):558-60. doi: 10.1007/s11748-015-0545-8. Epub 2015 Apr 10.

    PMID: 25860987RESULT

  • Kobayashi S, Takeda Y, Nakahira S, Tsujie M, Shimizu J, Miyamoto A, Eguchi H, Nagano H, Doki Y, Mori M. Fibrin Sealant with Polyglycolic Acid Felt vs Fibrinogen-Based Collagen Fleece at the Liver Cut Surface for Prevention of Postoperative Bile Leakage and Hemorrhage: A Prospective, Randomized, Controlled Study. J Am Coll Surg. 2016 Jan;222(1):59-64. doi: 10.1016/j.jamcollsurg.2015.10.006. Epub 2015 Oct 23.

    PMID: 26597705RESULT

MeSH Terms

Conditions

Thyroid NeoplasmsSeroma

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jin Wook Yi, MD, MS

CONTACT

+82-2-2072-3243gnsljw@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants cannot know the Neoveil apply in their surgery
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Neoveil applied // Neoveil non-applied
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 27, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

December 31, 2020

Last Updated

April 27, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)