a study to compare the effectiveness of two devices, electrothermal bipolar vessel sealing device and conventional electrocautery for post operative axillary seroma in breast cancer patients undergoing mastectomy with axillary node dissection.

Comparison of Electrothermal Bipolar vessel sealing device and electrocautery for axillary seroma formation following level II axillary dissection for operable breast cancer

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625001428459

Enrollment

108

Registered

2025-12-17

Start date

2020-08-26

Completion date

2021-10-26

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study was to analyze the role of electrothermal bipolar vessel sealing device (EBVS) in hemostasis and in preventing seroma formation. It is expected that this will help in reducing hospital cost of repeated visits and interventions, reduce the duration of surgery, lessen the surgeon burden, improve patient satisfaction and allow early rehabilitation resulting in reduced psychological stress on patient. Hypothesis of the study was: There is a difference between the electrothermal bipolar vessel sealing device (EBVS) and conventional electrocautery in terms of frequency of post-operative axillary seroma formation in operable breast cancer patients undergoing Modified Radical Mastectomy with level II axillary dissection.

Interventions

The study compared outcomes of two different devices; Electrothermal Bipolar vessel sealing device (Ligasure) and conventional electrocautery (monopolar and suture ligation); in terms of axillary seroma formation in breast cancer patients undergoing mastectomy with Level II axillary dissection. Ligasure can seal vessels upto 7mm in diameter within 3-4 secs, and has thermal spread of <2mm. These devices were used during surgery and the team consisted of principle investigator with 4 years experie

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Female patients with biopsy proven operable breast carcinoma (any type) T1, T2 or T3 with clinically positive axillary lymph nodes (N1) requiring axillary dissection. 2. Age 18-80 years. 3. Breast cancer patients fulfilling the inclusion criteria, which gave consent for Modified Radical Mastectomy and wanted to be a part of the study.

Exclusion criteria

1. T4 tumors 2. Patients who had BMI > 30 3. Patients with recurrent breast carcinoma 4. Patients on anticoagulants (heparin, warfarin)

Outcome results