NCT03166384

Brief Summary

There was no study about application of electrosurgical bipolar sealing device for mastectomy in Korean population, because Korean national insurance did not cover use of the advanced sealing device until last year. Sample size of the previous studies was too small to draw a solid conclusion. Therefore, this study was designed prospectively to evaluate whether application of bipolar energy device for mastectomy could provide clinical benefit in terms of reducing seroma formation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

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

May 1, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2022

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

May 21, 2017

Last Update Submit

September 6, 2023

Conditions

Seroma as Procedural Complication

Keywords

electrosurgical bipolar sealing devices, breast cancer

Outcome Measures

Primary Outcomes (1)

  • Total drainage volume after surgery: mL

    Total amount of drainage until drain tube removal Drain tube removal timing: When drainage volume is under 50mL/day for at least 2 days

    Up to 30 weeks after surgery

Secondary Outcomes (5)

  • Total exact drainage volume

    Up to 30 weeks after surgery

  • Drainage volume In hospital: mL

    Up to 30 weeks after surgery

  • Total operation running time

    Up to 30 weeks after surgery

  • Complication ratio within a month after surgery

    Up to 1 year after surgery

  • Frequency of seroma aspiration

    Up to 30 weeks after surgery

Study Arms (2)

control group

ACTIVE COMPARATOR

For the patients in the control group, surgeon dose not use electrosurgical bipolar sealing device at all and use conventional tie and ligation methods during tissue dissection and vessel ligation. interventions: 'conventional suture and tie'

Procedure: conventional suture and tie

study group

EXPERIMENTAL

For the patients in the study group, the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible. interventions: electrosurgical bipolar sealing devices

Device: electrosurgical bipolar sealing devices

Interventions

electrosurgical bipolar sealing devicesDEVICE

Electrosurgical bipolar sealing devices use the body's own collagen and elastin to create a permanent fusion zone through a combination of pressure and energy. Previous studies suggested that surgery using these devices lead to significant decrease of seroma formation, however their advantages are not well established in case of mastectomy for breast cancer.

study group
conventional suture and tiePROCEDURE

the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.

control group

Eligibility Criteria

Age20 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and over
  • Patients planned to undergo total mastectomy and axillary lymph node dissection
  • Patients planned to undergo total mastectomy and sentinel lymph node biopsy and/or reconstruction
  • Patients planned to undergo partial mastectomy and axillary lymph node dissection

You may not qualify if:

  • Bilateral breast cancer patients
  • Male breast cancer patients
  • Patients who underwent ipsilateral axillar surgery or axillar radiation therapy
  • Recurrent breast cancer patients
  • Patients who cannot give informed consents such as non-Korean speakers and patients with intellectual disabilities
  • Vulnerable patients such as pregnant women for enrollment
  • Patients without drain catheter
  • Patients with Ductal carcinoma in situ who have not undergone ipsilateral sentinel lymph node biopsy or axillar lymph node dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (6)

  • van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.

    PMID: 21849243BACKGROUND

  • Manouras A, Markogiannakis H, Genetzakis M, Filippakis GM, Lagoudianakis EE, Kafiri G, Filis K, Zografos GC. Modified radical mastectomy with axillary dissection using the electrothermal bipolar vessel sealing system. Arch Surg. 2008 Jun;143(6):575-80; discussion 581. doi: 10.1001/archsurg.143.6.575.

    PMID: 18559751BACKGROUND

  • Nespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7.

    PMID: 22959311BACKGROUND

  • Cortadellas T, Cordoba O, Espinosa-Bravo M, Mendoza-Santin C, Rodriguez-Fernandez J, Esgueva A, Alvarez-Vinuesa M, Rubio IT, Xercavins J. Electrothermal bipolar vessel sealing system in axillary dissection: a prospective randomized clinical study. Int J Surg. 2011;9(8):636-40. doi: 10.1016/j.ijsu.2011.08.002. Epub 2011 Sep 10.

    PMID: 21925293BACKGROUND

  • Miyagi K, Rossi SH, Malata CM, Forouhi P. Novel use of LigaSure Impact electrosurgical bipolar vessel sealing system in skin-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Jun;68(6):e126-8. doi: 10.1016/j.bjps.2015.01.005. Epub 2015 Jan 26. No abstract available.

    PMID: 25682592BACKGROUND

  • Park HS, Lee J, Kim JY, Park JM, Kwon Y. A Prospective Randomized Study to Compare Postoperative Drainage After Mastectomy Using Electrosurgical Bipolar Systems and Conventional Electro-Cautery. J Breast Cancer. 2022 Aug;25(4):307-317. doi: 10.4048/jbc.2022.25.e29. Epub 2022 Jun 27.

    PMID: 35914746RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hyung Seok Park, MD

    Yonsei University College of Medicine, Korea

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 21, 2017

First Posted

May 25, 2017

Study Start

May 1, 2017

Primary Completion

March 1, 2020

Study Completion

June 27, 2022

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)