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Status unknownNCT04853680Updated Aug 25, 2021

Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.

An interventional study of Anti-adhesion barrier (Collarbarrier) in Thyroid Nodule, Thyroid Cancer and Voice Disorders, sponsored by Inha University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Inha University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

To determine whether the use of anti-adhesion barrier after thyroid surgery can prevent the voice changes after surgery, using objective voice-related indicators.

Read the detailed description
  • Randomized controlled study
  • Including 40 patients in each arm
  • Treatment: anti-adhesion barrier apply on the thyroidectomy space
  • Control: No use of anti-adhesion barrier
  • Primary outcome: VHI-30 (Voice handicap index)
  • Secondary outcome: findings from stroboscopy, CSL (Computerize Speech Lab)
  • Outcome measurement: preoperative, post-operative 3 months, post-operative 9 months.
02

Conditions studied

  • Thyroid Nodule
  • Thyroid Cancer
  • Voice Disorders
03

In context

Thyroid Nodule

207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 121 interventional studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

Inha University Hospital is the lead sponsor of 37 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing open thyroidectomy for thyroid cancer
  • Patients whose tumor size is less than 4cm
  • Patients who are not suspected of surrounding organ involvement (T4) or to central lymph nodes in preoperative imaging
  • Patients with no history of voice-related diseases prior to surgery
  • Patients with normal movement of both vocal cords in the preoperative vocal cord examination
  • Patients who consented to the study and obtained consent for the study

Exclusion criteria

Exclusion Criteria:

  • Patients with uncontrolled high blood pressure, diabetes, chronic renal failure, coagulation disease, etc.
  • History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.)
  • Medical history of drug or substance disorder (alcohol, etc.)
  • Patients with diseases related to airways, esophagus, and vocal cords (vocal palsy, vocal cord polyps, etc.)
  • Patients who have already had adhesions in the foreground due to radiation therapy or surgery on the foreground in the past.
  • Patients with a history of keloid or hypertrophic scars
  • Patients planning to perform lateral cervical lymph node dissection
  • Patients with medical thyroid disease, such as Graves' disease and thyroid inflammation in need of treatment
  • Pregnant or lactating female patients
  • Other patients who are in charge of clinical trials as unsuitable for participation in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Treatment

    Use of Anti-adhesion barrier on the thyroidectomy space. After the thyroidectomy, anti-adhesion barrier will be applied on the thyroidectomy space, around the trachea, cricothyroid muscle and platysma muscle before the closure of surgical wound.

    Device: Anti-adhesion barrier (Collarbarrier)

  • No intervention
    Control

    No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.

Interventions

  • DeviceAnti-adhesion barrier (Collarbarrier)

    Collagen derived anti-adhesion barrier

06

What researchers measure

Primary outcomes

  1. Voice Handicap Index - 30 (VHI-30)

    Overall score of VHI (Total 30 points)

    Time frame: Preoperative 1 day

  2. Voice Handicap Index - 30 (VHI-30)

    Overall score of VHI (Total 30 points)

    Time frame: Postoperative 3 months

  3. Voice Handicap Index - 30 (VHI-30)

    Overall score of VHI (Total 30 points)

    Time frame: Postoperative 9 months

Secondary outcomes

  1. Voice range profile (VRP)

    Mininum Hz, Maximal Hz

    Time frame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.

  2. GRBAS score

    Grade, Rough, Breathy, Asthenic, Strained score. (0-3 points in each parameter)

    Time frame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.

07

Study locations

1 of 1 sites recruiting
  • Inha University Hospital
    Incheon, 22332, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — In order to protect the privacy of patients, the original data of the study will not be disclosed.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Jun 2023, 23 months after the start.

Of 67 non-industry interventional studies with no phase under Thyroid Nodule, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's planned 23 months is below that.

Counting every sponsor, half of 71 studies reached it within 30 months; a quarter within 14 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2021
First posted
Apr 21, 2021
StartActual
Jul 1, 2021
Primary completionEst.
Jun 30, 2023
CompletionEst.
Jul 30, 2023
Last update
Aug 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04853680
Lead sponsor
Inha University Hospital
Responsible party
Jin Wook Yi (Assistant Professor, Inha University Hospital) — Principal investigator
First posted
Apr 21, 2021
Start date
Jul 1, 2021
Primary completion
Jun 30, 2023 (estimated)
Completion
Jul 30, 2023 (estimated)
Last update
Aug 25, 2021

Study contacts

Jin Wook Yi, Professor
Contact
jinwook.yi@inha.ac.kr
+82-32-890-3437

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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