NCT05684536

Brief Summary

To compare intraoperative and postoperative complication rates in thyroidectomy between ligasure and traditional vascular ligation and clipping .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 5, 2023

Last Update Submit

January 5, 2023

Conditions

Ligature; HemorrhageRecurrent Laryngeal Nerve InjuriesHypocalcemia

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications

    Including RLN palsy , hypocalcemia , hemorrhage wound infection

    Postoperatively from day of surgery until one week post operatively

Study Arms (2)

ligasure throidectomy

ACTIVE COMPARATOR

the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery

Device: liagsure device

conventional thyroidectomy

NO INTERVENTION

with dissection around ligament of berry and inferior thyroidal artery through ligation with vicryl and hemoclips

Interventions

liagsure deviceDEVICE

the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall, with dissection around ligament of berry and inferior thyroidal artery

ligasure throidectomy

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who will undergo lobectomy , subtotal thyroidectomy , total thyroidectomy at time of study
  • Any age

You may not qualify if:

  • patient undergoing re-do surgery " completion thyroidectomy "
  • patient undergoing concomitant procedures as cervical lymphadenectomy or parathyroidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HemorrhageRecurrent Laryngeal Nerve InjuriesHypocalcemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLaryngeal Nerve InjuriesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve InjuriesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

January 15, 2023

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01