Jonathan Thompson, MD1, Vikrom K Dhar, MD2, Dennis J Hanseman, PhD2, Brad M Watkins, MD2, Thomas Inge, MD, PhD3, John Morton, MD, MPH4, Tayyab Diwan, MD2. 1University of Cincinnati Research Institute, 2Department of Surgery, University of Cincinnati College of Medicine, 3Children’s Hospital of Colorado, University of Colorado, Denver, 4Department of Surgery, Stanford University
Objective of the technology or device: Current techniques for gastric pouch creation with use of a bougie in laparoscopic sleeve gastrectomy (LSG) have been shown to result in variable pouch anatomy, leading to inconsistent and suboptimal clinical outcomes. We set out to create a novel clamping device and technique that aids surgeons in the creation of anatomically-consistent gastric pouches during LSG. This clamping device is the precursor to a full-length, single-cartridge sleeve gastrectomy stapler.
Description of the technology and method of its use or application: The Standard Clamp from Standard Bariatrics (Cincinnati, Ohio) is an FDA-approved laparoscopic clamp used to facilitate the proper formation of the sleeve gastrectomy staple line prior to transection. The Standard Clamp is a reusable non-crushing clamp that has a functional clamping length of 25cm and a width of 10mm. The jaws are designed to clamp at an angle to accommodate the variable thickness of the stomach.
Prior to insertion of the device, three anatomic landmarks of the stomach are identified and marked with ink: 1cm from the gastroesophageal junction, 3cm from the incisura angularis, and 6cm from the pylorus. The Standard Clamp is then introduced and the three points are aligned to the anatomic left of the clamp, ensuring a flat plane of both sides of stomach. The staple line is then created along this line.
Preliminary results: We performed a retrospective review of LSG cases performed in 2016 at a center specializing in bariatric surgery. Patients underwent LSG with either use of a 40F Bougie (ViSiGi 3D from Boehringer Laboratories; Phoenixville, PA) to guide sleeve formation or use of the Standard Clamp (SC) with three point technique.
175 consecutive patients underwent LSG for management of morbid obesity either with the SC (n = 36) or with use of a Bougie (n = 139). Sleeves created with SC have a curved shape and a visually appealing, consistent shape and volume free of kinks, twists, zig-zags or spirals (Figure 1). There were no intraoperative complications in either group. When comparing the SC group to the Bougie group, there were no significant differences in operative time (105 minutes vs. 108 minutes; p = 0.33), overall length of stay (1.33 days vs. 1.48 days; p = 0.55), follow up nausea rate (19% vs. 22%; p = 0.82), or follow up GERD rate (14% vs. 17%; p = 0.80). Use of the SC resulted in a decreased post operative complication rate (6% vs. 17%; p = 0.11), including readmissions and dehydration.
Conclusions/future directions: Using the Standard Clamp with three point technique is a safe and effective approach in LSG with favorable early outcomes compared to surgery performed with Bougie guidance. We observed a trend toward reduced post op complications with the new technique. These results are encouraging for the continued development of a single-cartridge sleeve gastrectomy stapler based on the Standard Clamp.
Figure 1: Anatomy-based sleeve gastrectomy pouch created with the Standard Clamp. The resultant staple line is shown insufflated with 60ml of air.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 84374
Program Number: ETP731
Presentation Session: Emerging Technology Poster
Presentation Type: Poster