Daisuke Fukui1, Mamoru Kawakami2, Shin-Ichi Nakao2, Erabu Miyamoto2, Shouko Morishita2, Toshiko Matuoka2, Hiroshi Yamada3. 1. Spine Care Center, Wakayama Medical University Kihoku Hospital, 219, Myouji, Katsuragicho, Ito Gun, Wakayama, Japan. taiga26@zeus.eonet.ne.jp. 2. Spine Care Center, Wakayama Medical University Kihoku Hospital, 219, Myouji, Katsuragicho, Ito Gun, Wakayama, Japan. 3. Orthopaedics Surgery, Wakayama Medical University, 811-1, Kimiidera, Wakayama City, Wakayama, Japan.
Abstract
PURPOSE: A bipolar sealer using Transcollation® technology, a combination of radiofrequency energy and saline, can provide hemostasis at 100 °C, which is lower than that used in standard electrocautery. Previous studies of joint arthroplasty have shown that use of the bipolar sealer reduces blood loss and tissue damage during the operation. However, it is unknown whether a bipolar sealer reduces blood loss and tissue damage in lumbar posterolateral fusion (PLF) surgery. The purpose of this study was to analyze the efficacy of this device in limiting blood loss during exposure of the lumbar spine in the treatment of PLF and postoperative pain. METHODS:Fifty patients who underwent PLF were prospectively enrolled between October 2011 and March 2013. Twenty-five patients were randomized to the bipolar sealer group (BS group) and 25 patients to the standard electrocautery group (control group). Operative time and blood loss during exposure of posterior bony elements including the transverse process for PLF, visual analog scale (VAS) to quantify postoperative pain, and the interval from the surgery to hospital discharge were compared. RESULTS:Operative time and blood loss expressed per level of exposure were significantly lower in the BS group than in the control group. There was a tendency toward a lower VAS at postoperative week 1 in the BS group. The duration of hospitalization was 15 and 26 days in the BS and control groups, respectively. CONCLUSIONS: A large randomized control trial adjusted for the number of fusion levels and body mass index is required to confirm the novelty value of this new bipolar sealers.
RCT Entities:
PURPOSE: A bipolar sealer using Transcollation® technology, a combination of radiofrequency energy and saline, can provide hemostasis at 100 °C, which is lower than that used in standard electrocautery. Previous studies of joint arthroplasty have shown that use of the bipolar sealer reduces blood loss and tissue damage during the operation. However, it is unknown whether a bipolar sealer reduces blood loss and tissue damage in lumbar posterolateral fusion (PLF) surgery. The purpose of this study was to analyze the efficacy of this device in limiting blood loss during exposure of the lumbar spine in the treatment of PLF and postoperative pain. METHODS: Fifty patients who underwent PLF were prospectively enrolled between October 2011 and March 2013. Twenty-five patients were randomized to the bipolar sealer group (BS group) and 25 patients to the standard electrocautery group (control group). Operative time and blood loss during exposure of posterior bony elements including the transverse process for PLF, visual analog scale (VAS) to quantify postoperative pain, and the interval from the surgery to hospital discharge were compared. RESULTS: Operative time and blood loss expressed per level of exposure were significantly lower in the BS group than in the control group. There was a tendency toward a lower VAS at postoperative week 1 in the BS group. The duration of hospitalization was 15 and 26 days in the BS and control groups, respectively. CONCLUSIONS: A large randomized control trial adjusted for the number of fusion levels and body mass index is required to confirm the novelty value of this new bipolar sealers.
Authors: Wael K Barsoum; Alison K Klika; Trevor G Murray; Carlos Higuera; Ho H Lee; Viktor E Krebs Journal: J Bone Joint Surg Am Date: 2011-03-16 Impact factor: 5.284
Authors: Ralph Hollmann; Christian E Hort; Erich Kammer; Markus Naegele; Markus W Sigrist; Claudia Meuli-Simmen Journal: Plast Reconstr Surg Date: 2004-08 Impact factor: 4.730
Authors: David A Geller; Allan Tsung; Vivek Maheshwari; Lisa A Rutstein; John J Fung; J Wallis Marsh Journal: HPB (Oxford) Date: 2005 Impact factor: 3.647
Authors: Christopher Mikhail; Zach Pennington; Paul M Arnold; Darrel S Brodke; Jens R Chapman; Norman Chutkan; Michael D Daubs; John G DeVine; Michael G Fehlings; Daniel E Gelb; George M Ghobrial; James S Harrop; Christian Hoelscher; Fan Jiang; John J Knightly; Brian K Kwon; Thomas E Mroz; Ahmad Nassr; K Daniel Riew; Lali H Sekhon; Justin S Smith; Vincent C Traynelis; Jeffrey C Wang; Michael H Weber; Jefferson R Wilson; Christopher D Witiw; Daniel M Sciubba; Samuel K Cho Journal: Global Spine J Date: 2020-01-06