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Comparative Analysis Between Bipolar Device and Conventional Tie & Suture Technique in Thyroidectomy

NCT02140476 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-05-28

No results posted yet for this study

Summary

Bipolar sealing and cutting devices such as EnSeal® G2 Tissue Sealer are surgical instruments that use electrical powered diathermic energy to seal and transect tissue. These devices have shown high efficiency in a wide variety of open and laparoscopic general and gynecological surgical procedures.

The surgical performance of the EnSeal® has shown to be comparable to that of ultrasonic cutting devices in several studies. However, the efficacy of this instrument and in particular of new instruments such as the EnSeal® G2 Tissue Sealer has not been evaluated in thyroid surgery.

Our primary aim is to verify whether the EnSeal® performance is superior to the standard surgical technique for thyroidectomy in a randomized clinical trial on 2 different institutions.

Conditions

  • Thyroid Goiter
  • Papillary Thyroid Cancer

Interventions

DEVICE

Bipolar vessel sealing and cutting device

This device will be used in half of the patients with thyroid goiter and half of the patients with papillary thyroid cancer.

PROCEDURE

Conventional thyroidectomy

Tie and suture technique. This device will be used in half of the patients with thyroid goiter and half of the patients with papillary thyroid cancer.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Miguel F Herrrera, MD PhD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  • Erivelto Volpi, MD · Universidad de Sao Paulo

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • Brazil
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140476 on ClinicalTrials.gov