A randomized comparison of a new flexible bipolar hemostasis forceps designed principally for NOTES versus a conventional surgical laparoscopic bipolar forceps for intra-abdominal vessel sealing in a porcine model

Background

Current devices for hemostasis in flexible endoscopy are inferior to methods used during open or laparoscopic surgery and might be ineffective for natural orifice transluminal endoscopic surgery.

Objective

To compare new flexible bipolar forceps (FBF), designed principally for natural orifice transluminal endoscopic surgery, with laparoscopic bipolar forceps (LBF) for hemostasis of intra-abdominal porcine arteries.

Setting

Surgical laboratories in Europe and the United States.

Design and Interventions

New FBF for hemostasis (3.7-mm diameter), featuring electrode isolation, were compared with rigid 5-mm LBF (ERBE BiClamp LAP forceps) at recommended settings. A porcine model of acute hemostasis was prepared by suturing the uterine horns and cecum to the abdominal wall, exposing uterine arteries, ovarian pedicles, cecal mesenteric bundles, and the inferior mesenteric artery. This allowed access to 10 vessels in each pig by transabdominal laparoscopic devices or a transgastric double-channel gastroscope. Vessels were measured, coagulated at 4 and more points, and transected. Blood pressure was increased to more than 200 mm Hg for 10 minutes by administering phenylephrine. Delayed bleeding was identified.

Main Outcome Measurements

In 7 pigs, a total of 65 vessels (1.5-6.0 mm) were randomly allocated to FBF (n = 32) or LBF (n = 33). Successful hemostasis both before and after blood pressure increase was equivalent between the 2 groups (before: 88% FBF vs 88% LBF, not significant [NS]; after: 97% FBF vs 94% LBF, NS). With FBF, the number of seals per vessel was 4.8 vs 4.4 with LBF (NS). The energy used to create FBF seals was 19.8 J vs 38.2 J for LBF (P < .05).

Limitations

Results from porcine studies may not reflect patient outcomes.

Conclusions

In a porcine model, transgastric FBF endoscopic hemostasis was as effective as conventional laparoscopic hemostasis using LBF across a wide range of vessels.

Abbreviations: FBF, flexible bipolar forceps, lbf, pounds per square inch, LBF, laparoscopic bipolar forceps, NOTES, natural orifice transluminal endoscopy surgery