Management of Intraoperative Hemorrhage During NOTES®: A Prospective Randomized Comparison

Byron F Santos, MD, Stephen S Plachta, BS, Nathaniel J Soper, MD, Eric S Hungness, MD. Northwestern University Department of Surgery, Chicago, IL

Introduction: The optimal strategy to manage intraoperative hemorrhage during NOTES is unknown. We performed a randomized comparison of three instruments for hemorrhage control during hybrid transvaginal NOTES: prototype endoscopic bipolar hemostasis forceps (BELA), prototype endoscopic clip (E-CLIP) appliers, or conventional laparoscopic clip (L-CLIP) appliers.

Methods: Transvaginal access was obtained in swine using a dual-channel, flexible gastroscope, under an IACUC-approved protocol. The gastroepiploic (GE) arterio-venous bundle (~3mm vessels) was transected to induce hemorrhage. Hemostasis was attempted using a hybrid NOTES technique (flexible endoscope plus a single umbilical port) with the BELA, E-CLIP, or L-CLIP. Full laparoscopic salvage was performed if hemorrhage control failed after 10 minutes. Hemorrhage was re-induced a total of three times on the GE vessels and also in 1-2mm, distal mesenteric vessels (MV), with each hemostasis attempt utilizing a different instrument in a sequential, randomized fashion. Outcomes included primary success rate (PS), primary hemostasis time (PHT), total number of device applications (DA), and salvage success rate (SS).

Results: A total of 70 hemostasis attempts were made in 12 swine. PS was similar for all techniques on MV (80-100%) but the BELA and L-CLIP resulted in shorter mean PHT compared to E-CLIP. PS was worse on GE vessels (42-67%) compared to MV, with significantly longer PHT and higher DA, but similar performance between techniques. Laparoscopic salvage took an average of 101 ± 41 sec for the MV and 306 ± 125 sec for the GE vessels, regardless of which instrument was used during the initial hemostasis attempt.

Outcomes, by Instrument and Artery (Mean ± SD)
BELA E-CLIP L-CLIP Difference p – value
Primary Success (PS) – % MV 100% 80% 100% None .08
GE 67% 42% 67% None .36
Primary Hemostasis Time (PHT) – sec. MV 203 ± 67 362 ± 93 144 ± 63 BELA, L-CLIP < E-CLIP .001
GE 521 ± 76 445 ± 127 462 ± 143 None NS
Total Device Applications (DA) – no. MV 5 ± 2 3 ± 1 3 ± 1 None NS
GE 12 ± 5 2 ± 1 7 ± 2 BELA > L-CLIP > E-CLIP .002
Salvage Success (SS) – % MV 100%
GE 100% 100% 100% None NS

Conclusion: All three instruments had similar effectiveness in achieving primary hemostasis during hybrid NOTES. Management of small vessel bleeding (1-2 mm vessels) in a porcine hybrid NOTES model is effective using all three instruments, but may be most efficient with the BELA or L-CLIP. To control bleeding from larger vessels (3 mm or greater), however, the most effective and efficient approach may be to add additional laparoscopic ports for assistance, and maintain a low threshold for conversion to full laparoscopy.


Session: Poster
Program Number: P210
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