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ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery (ELBCE)

Primary Purpose

Seroma as Procedural Complication

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
electrosurgical bipolar sealing devices
conventional suture and tie
Sponsored by
Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seroma as Procedural Complication focused on measuring electrosurgical bipolar sealing devices, breast cancer

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 20 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

study group

Arm Description

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'

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total exact drainage volume
total amount volume of drainage bag and amount of aspiration from seroma after drain tube removal
Drainage volume In hospital: mL
Drainage volume In hospital: mL
Total operation running time
Total operation running time
Complication ratio within a month after surgery
possible pre-defined complications were defined in reference to previous studies
Frequency of seroma aspiration
examination for frequency and total amount of seroma aspiration within a month after surgery. Under 10mL/day, aspiration is stopped

Full Information

First Posted
May 21, 2017
Last Updated
September 6, 2023
Sponsor
Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03166384
Brief Title
ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery
Acronym
ELBCE
Official Title
A Prospective Randomized Study Comparing Surgery Using Electrosurgical Bipolar Sealing Devices and Surgery Using Conventional Electro-cautery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Lymphorrhea and seroma are the most common complications of mastectomy in patients with breast cancer. Seroma formation increases admission period, follow-up duration, and postoperative discomforts. Repeated aspiration of seroma increases risk of re-admission due to wound infection. Seroma formation after mastectomy occurs in 10% to 85% of cases with mastectomy. Known risk factors according to previous studies are old age(>60 years), high BMI, tumor size, preoperative chemotherapy, surgical extent, and number of retrieved lymph nodes. To reduce postoperative complications including seroma formation, meticulous hemostasis and lymphatic ligation technique are necessary. Procedures using new surgical devices such as bipolar sealing devices have been introduced. 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. Several studies showed that an advanced sealing system like bipolar energy sealing system can reduce operative time and cost for postoperative management compared to conventional clamp and tie method in non-breast surgery. If electrosurgical bipolar sealing devices are applied during mastectomy, there would be several potential benefits on vessel and lymphatic ligation. Conventional ligation and monopolar cauterization have several weak points including incompletion of ligation and thermal injury during procedures. On the other hand, electrosurgical bipolar sealing devices can provide a combination of pressure and energy simultaneously to minimize thermal injury and create a permanent fusion zone. Previous studies suggested that electrosurgical bipolar sealing devices shortened removal time of drain after axillary lymph node dissection compared with conventional methods. Another study reported benefits on reducing blood loss, drainage amount, and length of hospital stay. Moreover, a recent study also reported that skin sparing mastectomy using electrosurgical bipolar sealing devices can be used in patients with breast cancer. However, there are several limitations in previous studies. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma as Procedural Complication
Keywords
electrosurgical bipolar sealing devices, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
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'
Arm Title
study group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
electrosurgical bipolar sealing devices
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional suture and tie
Intervention Description
the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.
Primary Outcome Measure Information:
Title
Total drainage volume after surgery: mL
Description
Total amount of drainage until drain tube removal Drain tube removal timing: When drainage volume is under 50mL/day for at least 2 days
Time Frame
Up to 30 weeks after surgery
Secondary Outcome Measure Information:
Title
Total exact drainage volume
Description
total amount volume of drainage bag and amount of aspiration from seroma after drain tube removal
Time Frame
Up to 30 weeks after surgery
Title
Drainage volume In hospital: mL
Description
Drainage volume In hospital: mL
Time Frame
Up to 30 weeks after surgery
Title
Total operation running time
Description
Total operation running time
Time Frame
Up to 30 weeks after surgery
Title
Complication ratio within a month after surgery
Description
possible pre-defined complications were defined in reference to previous studies
Time Frame
Up to 1 year after surgery
Title
Frequency of seroma aspiration
Description
examination for frequency and total amount of seroma aspiration within a month after surgery. Under 10mL/day, aspiration is stopped
Time Frame
Up to 30 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung Seok Park, MD
Organizational Affiliation
Yonsei University College of Medicine, Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21849243
Citation
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.
Results Reference
background
PubMed Identifier
18559751
Citation
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.
Results Reference
background
PubMed Identifier
22959311
Citation
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.
Results Reference
background
PubMed Identifier
21925293
Citation
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.
Results Reference
background
PubMed Identifier
25682592
Citation
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.
Results Reference
background
PubMed Identifier
35914746
Citation
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.
Results Reference
result

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ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery

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