NCT02140476

Brief 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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
2 countries

2 active sites

Status
unknown

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

May 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 9, 2014

Last Update Submit

May 27, 2014

Conditions

Thyroid GoiterPapillary Thyroid Cancer

Keywords

Thyroid goiterPapillary thyroid cancerBipolar deviceSealing and cutting deviceThyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Operative time and surgical safety

    The primary outcomes will be operative time (minutes), blood loss (milliliters), transient and permanent hypoparathyroidism (calcium and PTH levels), loss of signal in laryngeal nerve monitoring, number of ligatures and pain intensity (EVA score).

    One year

Secondary Outcomes (1)

  • Surgical complications

    one year

Study Arms (2)

Thyroid Goiter

EXPERIMENTAL

Benign thyroid disease with a nodule equal or lesser than 4 cm in diameter of any gender or ethnical origin. Half of these patients will undergo either bipolar or conventional thyroidectomy.

Device: Bipolar vessel sealing and cutting deviceProcedure: Conventional thyroidectomy

Papillary Thyroid Cancer

ACTIVE COMPARATOR

Patients of any gender or ethnical origin with papillary thyroid cancer no greater than 4 cm in diameter. Half of these patients will undergo either bipolar or conventional thyroidectomy.

Device: Bipolar vessel sealing and cutting deviceProcedure: Conventional thyroidectomy

Interventions

Bipolar vessel sealing and cutting deviceDEVICE

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

Also known as: EnSeal® G2 Tissue Sealer
Papillary Thyroid CancerThyroid Goiter
Conventional thyroidectomyPROCEDURE

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.

Papillary Thyroid CancerThyroid Goiter

Eligibility Criteria

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

You may qualify if:

  • Patients with thyroid diseases amenable of surgical resection
  • Benign or malign thyroid disease
  • Thyroid nodules ≤ 4cm
  • Patients with any gender or ethnical origin
  • Adults patients with 18-65 years-old
  • Postoperative follow-up of at least 2 weeks
  • Patients competent to understand and sign the informed consent

You may not qualify if:

  • Patients with clinical or biochemical hyperthyroidism
  • Preoperative indication for lateral lymph node dissection (radical modified)
  • Presence of gross tracheal or laryngeal invasion with thyroid cancer
  • Preoperative vocal cord paralysis or laryngeal disease
  • Patients with bleeding disorders or using anticoagulants
  • Patients with advanced or undifferentiated thyroid cancer
  • Patients with secondary hyperparathyroidism or parathyroid disease
  • Patients who do not want to accept to participate in the study
  • Elimination Criteria:
  • Intraoperative indication of lateral lymph node dissection (radical modified)
  • Intraoperative requirement of any tracheal or laryngeal resection
  • Malfunction of the devices (EnSeal or neuro-monitoring)
  • Any intraoperative conditions of the patient that require to stop or modified the surgery
  • Incomplete records, laboratories or clinical follow-up
  • Patients from vulnerable populations or non-competent to understand or sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Das Clinicas, Universidad de Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

NOT YET RECRUITING

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

RECRUITING

Related Publications (3)

  • Janssen PF, Brolmann HA, Huirne JA. Effectiveness of electrothermal bipolar vessel-sealing devices versus other electrothermal and ultrasonic devices for abdominal surgical hemostasis: a systematic review. Surg Endosc. 2012 Oct;26(10):2892-901. doi: 10.1007/s00464-012-2276-6. Epub 2012 Apr 27.

    PMID: 22538684BACKGROUND

  • Person B, Vivas DA, Ruiz D, Talcott M, Coad JE, Wexner SD. Comparison of four energy-based vascular sealing and cutting instruments: A porcine model. Surg Endosc. 2008 Feb;22(2):534-8. doi: 10.1007/s00464-007-9619-8. Epub 2007 Dec 20.

    PMID: 18097720BACKGROUND

  • Newcomb WL, Hope WW, Schmelzer TM, Heath JJ, Norton HJ, Lincourt AE, Heniford BT, Iannitti DA. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009 Jan;23(1):90-6. doi: 10.1007/s00464-008-9932-x. Epub 2008 May 16.

    PMID: 18483824BACKGROUND

MeSH Terms

Conditions

GoiterThyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesAdenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Study Officials

  • Miguel F Herrrera, MD PhD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

  • Erivelto Volpi, MD

    Universidad de Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel F Herrera, MD PhD

CONTACT

54870900miguelfherrera@gmail.com

David Velázquez, MD MSc PhD

CONTACT

54870900velazquezmerlin2004@yahoo.com.mx

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 16, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

July 1, 2015

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

BR(1)ME(1)