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ABSTRACT: 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.
SUBMITTER: Keelan S
PROVIDER: S-EPMC10946413 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
Keelan Stephen S Dowling Gavin P GP Roche Trudi T Hegarty Aisling A Davey Matthew G MG Dhannoon Amenah A AA O'Grady Sorcha S Downey Eithne E Bolger Jarlath J Boland Michael M Sorensen Jan J Power Colm C Butt Abeeda A Baban Chwanrow C Hill Arnold D K ADK
The British journal of surgery 20240301 3
<h4>Background</h4>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.<h4>Methods</h4>Patients were recruited prospectively and randomized in a 1 : 1 manner to undergo simple ...[more]