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
Received 20 April 2009; accepted 8 August 2009. published online 30 November 2009. Corrected Proof
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.
Göteborg, Sweden, Lebanon, New Hampshire, USA, London, United Kingdom, Cincinnati, Ohio, USA
Current affiliations: Department of Surgery (P.-O.P., M.B.), Sahlgrenska University Hospital/Östra, Göteborg, Sweden, Section of Gastroenterology and Hepatology (R.I.R.), Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA, Department of Surgical Oncology and Technology (P.S.), Imperial College, London, United Kingdom, Ethicon Endo-Surgery, Inc. (C.C., O.-J.V., G.J.B., K.R.B.), Cincinnati, Ohio, USA
Reprint requests: C. Paul Swain, MD, Department of Surgical Oncology and Technology, St. Mary's Hospital, 41 Willow Road, London NW3 1TN, United Kingdom.
DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: P.-O. Park, M. Bergström, R.I. Rothstein, and C.P. Swain: consultants for Ethicon Endo-Surgery. G.L. Long, C. Cunningham, O.J. Vakharia, G.J. Bakos, K.R. Bally: current or former employees of Ethicon Endo-Surgery.
ABSTRACT