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|
|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%||–||–||–|
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.
Program Number: P210