Seroma as Procedural ComplicationELBCENCT03166384
ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery
A study testing electrosurgical bipolar sealing devices and conventional suture and tie in people with Seroma as Procedural Complication, run by Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years, women only
- Conditions the study is for
- Seroma as Procedural Complication
- What is being tested?
- electrosurgical bipolar sealing devices and conventional suture and tie
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2017to 27 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study Comparing Surgery Using Electrosurgical Bipolar Sealing Devices and Surgery Using Conventional Electro-cautery
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.
Read the 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.
- Conditions
- Seroma as Procedural Complication
- Being tested
- electrosurgical bipolar sealing devices, conventional suture and tie
- Keywords
- electrosurgical bipolar sealing devices, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
conventional suture and tieProcedure or surgery
the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: 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 Receives: Device: electrosurgical bipolar sealing devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 weeks after surgery
Secondary outcomes (5)
Total exact drainage volume
total amount volume of drainage bag and amount of aspiration from seroma after drain tube removal
Measured: Up to 30 weeks after surgery
Drainage volume In hospital: mL
Drainage volume In hospital: mL
Measured: Up to 30 weeks after surgery
Total operation running time
Total operation running time
Measured: Up to 30 weeks after surgery
Complication ratio within a month after surgery
possible pre-defined complications were defined in reference to previous studies
Measured: Up to 1 year after surgery
Frequency of seroma aspiration
examination for frequency and total amount of seroma aspiration within a month after surgery. Under 10mL/day, aspiration is stopped
Measured: Up to 30 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 May 2017
- Primary completion1 Mar 2020
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Seroma as Procedural ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Seok Park, MD, PhD, Severance Hospital
- Investigators
- Hyung Seok Park, MD, Study chair, Yonsei University College of Medicine, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166384
- Sponsor's protocol ID
- 1-2017-0002
- Acronym
- ELBCE
- Status last verified
- Sep 2023
- First submitted
- 21 May 2017
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21849243Manouras 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.
PubMed 18559751Nespoli 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.
PubMed 22959311Cortadellas 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.
PubMed 21925293Miyagi 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.
PubMed 25682592Park 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.
PubMed 35914746
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing Surgery Using Electrosurgical Bipolar Sealing Devices and Surgery Using Conventional Electro-cautery
- ClinicalTrials.gov ID
- NCT03166384
- Acronym / sponsor ID
- ELBCE / 1-2017-0002
- Conditions
- Seroma as Procedural Complication
- Keywords
- electrosurgical bipolar sealing devices, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: conventional suture and tieFor 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' |
| study group | Experimental | Device: electrosurgical bipolar sealing devicesFor 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 |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrosurgical bipolar sealing devicesElectrosurgical 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. | Device | study group |
| conventional suture and tiethe surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible. | Procedure or surgery | control group |
Primary outcome
Total drainage volume after surgery: mL
Time frame: Up to 30 weeks after surgery
Total amount of drainage until drain tube removal Drain tube removal timing: When drainage volume is under 50mL/day for at least 2 days
5 secondary outcomes
Total exact drainage volume
Time frame: Up to 30 weeks after surgery
Drainage volume In hospital: mL
Time frame: Up to 30 weeks after surgery
Total operation running time
Time frame: Up to 30 weeks after surgery
Complication ratio within a month after surgery
Time frame: Up to 1 year after surgery
Frequency of seroma aspiration
Time frame: Up to 30 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 21849243van 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.
- Background: PubMed 18559751Manouras 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.
- Background: PubMed 22959311Nespoli 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.
- Background: PubMed 21925293Cortadellas 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.
- Background: PubMed 25682592Miyagi 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 publication: PubMed 35914746Park 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.
- Individual participant dataSharing planned: No
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Parotid Neoplasms, Post-operative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung Seok Park, MD study chair
Yonsei University College of Medicine, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrosurgical bipolar sealing devices and conventional suture and tie in people with Seroma as Procedural Complication, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total drainage volume after surgery: mL (time frame: Up to 30 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166384, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.