Bipolar coagulation with the BiClamp forceps versus conventional suture ligation: a multicenter randomized controlled trial in 175 vaginal hysterectomy patients.
OBJECTIVE
To compare bipolar vessel sealing (BVS; BiClamp) versus conventional suture ligation in vaginal hysterectomy.


METHODS
A multicenter, single-blind randomized controlled trial (RCT) was conducted at eight women's hospitals in Germany. One hundred and seventy-five patients with benign uterine disease underwent vaginal hysterectomy using BVS (n = 88) or conventional suture ligation (n = 87 controls). Data analysis was based on intention-to-treat.


RESULTS
Postoperative pain (primary endpoint) was decreased in the BVS group, but not significantly. Intraoperative blood loss was significantly lower in this group, with <100 mL recorded in 79/88 versus 52/86 patients (P < 0.001). Hemoglobin decrease indicated non-significantly lower blood loss in the BVS group. Operating time was significantly shorter in the BVS group than in the controls (38.0 +/- 18.6 vs. 48.0 +/- 24.9 min; P = 0.001). On average, 7.8 sutures/operation were saved with bipolar coagulation (P < 0.0001). Ease of use ratings were significantly higher for BVS. Hospital stay was similar for both groups. Adverse event rates did not differ significantly.


CONCLUSIONS
The BiClamp procedure proved superior or similar to conventional ligation, particularly with regard to intraoperative blood loss, operating time and postoperative pain, although statistical significance was not attained for postoperative pain. Moreover, BVS was easier to use and more cost effective.
Zubke
Wolfgang
W
Department of Obstetrics and Gynecology, University of Tübingen, Calwerstr. 7, 72076 Tübingen, Germany. wolfgang.zubke@med.uni-tuebingen.de
Hornung
René
R
Wässerer
Sabine
S
Hucke
Jürgen
J
Füllers
Ulrich
U
Werner
Christoph
C
Schmitz
Peter
P
Lobodasch
Kurt
K
Hammermüller
Uwe
U
Wojdat
Richard
R
Volz
Joachim
J
De Wilde
Rudy L
RL
Wallwiener
Diethelm
D
D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control; D004598:Electrosurgery / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006488:Hemostasis, Surgical / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007045:Hysterectomy, Vaginal / Q000379:methods*; D008875:Middle Aged; D010149:Postoperative Pain / Q000517:prevention & control; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D014591:Uterine Diseases / Q000097:blood / Q000601:surgery*
D006454:Hemoglobins