NCT00524966

Brief Summary

RATIONALE: The use of bipolar energy sealing system or ultrasonic coagulation for hemostasis during thyroidectomy may reduce blood loss and hypocalcemia and may be more cost-effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

July 11, 2011

Status Verified

July 1, 2011

Enrollment Period

2 years

First QC Date

September 4, 2007

Last Update Submit

July 7, 2011

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Blood loss and hypocalcemia

    one week

Secondary Outcomes (1)

  • Cost of thyroidectomy

    one week

Interventions

Bipolar Versus Ultrasonic Hemostasis TechniquesPROCEDURE

OUTLINE: Patients undergoing thyroidectomy for thyroid cancer, thyroid nodules, hyperthyroidism and goiter will be randomized to either bipolar energy sealing system or ultrasonic coagulation.

Also known as: Harmonic, LigaSure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring thyroidectomy

You may not qualify if:

  • Patients unwilling or unable to provide informed consent
  • Age less than 18 years old
  • Reoperative case
  • Patients who use pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Second Harmonic Generation Microscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Nonlinear Optical MicroscopyMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Electron Kebebew, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 11, 2011

Record last verified: 2011-07

Locations

US(1)