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Energy Device Study in Transoral Endoscopic Thyroidectomy

Sponsor
Inha University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04320901
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
34.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: Ligasure
  • Device: Harmonic
 N/A

Detailed Description

  • This is a prospective randomized controlled study. The principal investigator or another clinical investigator in charge will individually inform the patients about the study, on the day before surgery.

  • When informed consent is obtained, an investigator in charge of randomization only, will randomize the patients.

  • According to randomization, the experimental group will Ligasure and the control group will use Harmonic ACE 7+. Other than the randomized use of energy devices, the protocol for TOETVA is performed as usual.

  • Operation time (from insertion of the laparoscopic camera to removal of the camera), number of times the camera was cleaned, intraoperative blood loss will recorded.

  • Postoperative hospital stay, visual analog pain scale, blood cell count and inflammatory parameters, postoperative drain amount will recorded.

  • Complications of thyroid surgery (vocal cord dysfunction, hypoparathyroidism) are compared for safety assessment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Harmonic

Endoscopic procedure will be done by Harmonic ACE7+

Device: Harmonic
Harmonic ACE 7+
Experimental: Ligasure

Endoscopic procedure will be done by Ligasure

Device: Ligasure
Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm

Outcome Measures

Primary Outcome Measures

  1. Operation time [During the procedure]

    Surgery time during the thyroid lobectomy

  2. Camera cleaning frequency [During the procedure]

    Numbers of camera cleaning during the lobectomy

  3. Blood loss [During the procedure]

    Estimated blood loss during the lobectomy

Secondary Outcome Measures

  1. Pain score [Postoperative 1st and 2nd days]

    visual analogue scale, ranged from 0-10 (0: no pain, 10: maximal pain)

  2. Drain amount [Postoperative 1st and 2nd days]

    24-hour drain amount (ml/day)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients who planned to transoral endoscopic thyroidectomy

  • Age between 20 to 70

  • Voluntarily consenting to the study and study agreement

  • No local invasion or distant metastasis

  • Normal vocal cord function in laryngoscopic exam

  • No significant abnormalities in preoperative laboratory tests

Exclusion Criteria:

  • Take aspirin or antiplatelet drugs within 7 days before admission

  • Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease

  • History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)

  • Substance abuse and alcohol abuse

  • History of esophageal and airway diseases

  • Patient was participated in other clinical trials within 30 days

  • History of neck irradiation or surgery

  • History of severe drug allergies

  • Pregnant or lactating women

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inha University Hospital Incheon Korea, Republic of 22332

Sponsors and Collaborators

  • Inha University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin Wook Yi, Assistant Professor, Inha University Hospital
ClinicalTrials.gov Identifier:
NCT04320901
Other Study ID Numbers:
  • 2020-01-033
First Posted:
Mar 25, 2020
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Nodule
Thyroid Diseases

Study Results

No Results Posted as of Feb 21, 2022