Royal College of Surgeons in Ireland
Browse
Monopolar diathermy versus a vessel-sealing device for reducing postoperative drain output after simple mastectomy_ randomized clinical trial.pdf (288.29 kB)

Monopolar diathermy versus a vessel-sealing device for reducing postoperative drain output after simple mastectomy: randomized clinical trial

Download (288.29 kB)
journal contribution
posted on 2024-03-27, 15:07 authored by Stephen Keelan, Gavin DowlingGavin Dowling, Trudi Roche, Aisling HegartyAisling Hegarty, Matthew G Davey, Amenah Dhannoon, Sorcha O'Grady, Eithne Downey, Jarlath BolgerJarlath Bolger, Michael Boland, Jan SorensenJan Sorensen, Colm PowerColm Power, Abeeda ButtAbeeda Butt, Chwanrow Baban, Arnold HillArnold Hill

Background: Electrosurgical devices are commonly used during mastectomy for simultaneous dissection and haemostasis, and can provide potential benefits regarding vessel and lymphatic ligation. The aim of this prospective RCT was to assess whether using a vessel-sealing device (LigaSure™) improves perioperative outcomes compared with monopolar diathermy when performing simple mastectomy.

Methods: Patients were recruited prospectively and randomized in a 1 : 1 manner to undergo simple mastectomy using either LigaSure™ or conventional monopolar diathermy at a single centre. The primary outcome was the number of days the drain remained in situ after surgery. Secondary outcomes of interest included operating time and complications.

Results: A total of 86 patients were recruited (42 were randomized to the monopolar diathermy group and 44 were randomized to the LigaSure™ group). There was no significant difference in the mean number of days the drain remained in situ between the monopolar diathermy group and the LigaSure™ group (7.75 days versus 8.23 days; P = 0.613) and there was no significant difference in the mean total drain output between the monopolar diathermy group and the LigaSure™ group (523.50 ml versus 572.80 ml; P = 0.694). In addition, there was no significant difference in the mean operating time between the groups, for simple mastectomy alone (88.25 min for the monopolar diathermy group versus 107.20 min for the LigaSure™ group; P = 0.078) and simple mastectomy with sentinel lymph node biopsy (107.20 min for the monopolar diathermy group versus 114.40 min for the LigaSure™ group; P = 0.440).

Conclusion: In this double-blinded single-centre RCT, there was no difference in the total drain output or the number of days the drain remained in situ between the monopolar diathermy group and the LigaSure™ group.

Registration number: EudraCT 2018-003191-13 BEAUMONT HOSPITAL REC 18/66. 

History

Data Availability Statement

Data will remain within the Department of Surgery, RCSI for an interval of 7 years after study closure. Data available for audit/ interrogation. Participants were asked to consent to future research within this field of research. Data can be made available for future research in this capacity

Comments

The original article is available at https://academic.oup.com/

Published Citation

Keelan S, et al. Monopolar diathermy versus a vessel-sealing device for reducing postoperative drain output after simple mastectomy: randomized clinical trial. Br J Surg. 2024;111(3):znae029.

Publication Date

18 March 2024

PubMed ID

38498075

Department/Unit

  • Surgery
  • Beaumont Hospital
  • Healthcare Outcomes Research Centre
  • School of Population Health

Publisher

Oxford University Press

Version

  • Published Version (Version of Record)

Usage metrics

    Royal College of Surgeons in Ireland

    Licence

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC