Objective: To systematically review the literature to assess electrothermal bipolar vessel sealing system EBVS (LigaSure™, Covidien Energy-based Devices, Boulder, CO) versus other methods for surgical hemostasis.
Methods: A search was conducted of the National Library of Medicine’s Medline & Cochrane Library databases from 1/1/2000-8/14/07 for prospective, randomized, clinical, comparative trials (RCTs) of EBVS. Initial search identified 242 articles. All case reports, animal or retrospective studies, or prospective series but without controls were ineligible, yielding 27 RCTs from 13 countries. One article had 2 comparator arms, qualifying 28 studies. Two authors independently abstracted data.
Results: These studies had a total of 1116 EBVS patients versus 1084 pts in the comparator arms. The surgeries included hemorrhoidectomy (12 articles), hysterectomy (4), colectomy (2), hepatic resection (2), thyroidectomy (2), and lap adrenalectomy, parotidectomy, gastric resection, lap radical nephrectomy, tonsillectomy with 1 study each. Sample sizes averaged 79 pts (range 11 – 125), with median follow-up of 30 days (range 1 day – 2 yrs). The most common endpoints were operative time (all 28 studies), blood loss (17/28 studies), and pain score/analgesic use (15/28 studies). Only 3/28 studies reported monetary costs as an endpoint. 22 of 24 studies that used conventional hemostatic methods (suture, clips, vascular/circular stapler, &/or monopolar diathermy) for the control group found EBVS to reduce operative time significantly, by an average of 19 mins (range 2 – 96 mins) or 31% of the case (range 5% – 68%). Two of 4 studies comparing EBVS to ultrasonic energy methods found reduced operative time. Of 13 studies comparing blood loss from EBVS versus conventional hemostasis, 7 had an average of 106ml (20 – 385ml) less blood loss, whereas 4 studies found no difference, and 2 did not state statistics. 3 of 4 studies versus ultrasonic energy found 135 ml (2 – 275ml) less blood loss with EBVS. Compared to conventional hemostasis, postop pain scores were significantly lower with EBVS in 8 of 15 studies, with no difference in 6 and an increase in postop pain in 1 study. Some of the studies that found less pain with EBVS also found less analgesic use, while others did not. 17 of 21 studies found that EBVS did not reduce hospital stay. No difference in complication rates was found. No adverse events related to EBVS were reported.
Conclusions: These RCT data indicate that EBVS reduces operative time & blood loss versus conventional methods for surgical hemostasis, and may reduce pain scores depending on the surgery type.
Program Number: P093