The colonoscopic vacuum model-simulating biomechanical restrictions to provide a realistic colonoscopy training environment.

INTRODUCTION: Practicing endoscopic procedures is fundamental for the education of clinicians and the benefit of patients. Despite a diverse variety of model types, there is no system simulating anatomical restrictions and variations in a flexible and atraumatic way. Our goal was to develop and validate a new modelling approach for adhesion forces between colon and abdominal wall. METHODS: An inlay for a standard mechanical trainer was designed and 3D printed. Colon specimens were fixed to the inlay along colon ascendens (CA) and colon descendens (CD) by a vacuum. Our system, which we refer to as Colonoscopy Vacuum Model (CoVaMo), was validated with 11 test persons with varying level of expertise. Each performed one colonoscopy and one polypectomy in the CoVaMo and in the Endoscopic Laparoscopic Interdisciplinary Training Entity (ELITE). Achieved adhesion forces, times required to fulfill different tasks endoscopically and a questionnaire, assessing proximity to reality, were recorded. RESULTS: Mean adhesion forces of 37 ± 7 N at the CA and 30 ± 15 N at the CD were achieved. Test subjects considered CoVaMo more realistic than ELITE concerning endoscope handling and the overall anatomy. Participants needed statistically significantly more time to maneuver from anus to flexura sinistra in CoVaMo (377 s ± 244 s) than in ELITE (58 s ± 49 s). CONCLUSION: We developed a training environment enabling anatomically and procedural realistic colonoscopy training requiring participants to handle all endoscope features in parallel. Fixation forces compare to forces needed to tear pig colon off the mesentery. Workflow and inlay can be adapted to any arbitrary ex vivo simulator.

Systematic Review and Meta-Analysis on Colorectal Anastomotic Techniques.

Purpose: Anastomosis creation after resective gastrointestinal surgery is a crucial task. The present review examines the techniques and implants currently available for anastomosis creation and analyses to which extent they already address our clinical needs, with a special focus on their potential to enable further trauma minimization in visceral surgery. Methods: A multi-database research was conducted in MEDLINE, Scopus, and Cochrane Library. Comparative controlled and uncontrolled clinical trials dealing with anastomosis creation techniques in the intestinal tract in both German and English were included and statistically significant differences in postoperative complication incidences were assessed using the RevMan5.4 Review Manager (Cochrane Collaboration, Oxford, UK). Results: All methods and implant types were analyzed and compared with respect to four dimensions, assessing the techniques' current performances and further potentials for surgical trauma reduction. Postoperative outcome measures, such as leakage, stenosis, reoperation and mortality rates, as well as the tendency to cause bleeding, wound infections, abscesses, anastomotic hemorrhages, pulmonary embolisms, and fistulas were assessed, revealing the only statistically significant superiority of hand-suture over stapling anastomoses with respect to the occurrence of obstructions. Conclusion: Based on the overall complication rates, it is concluded that none of the anastomosis systems addresses the demands of operative trauma minimization sufficiently yet. Major problems are furthermore either low standardization potentials due to dependence on the surgeons' levels of experience, high force application requirements for the actual anastomosis creation, or large and rigid device designs interfering with flexibility demands and size restrictions of the body's natural access routes. There is still a need for innovative technologies, especially with regard to enabling incisionless interventions.

Design of a force-measuring setup for colorectal compression anastomosis and first ex-vivo results.

PURPOSE: The introduction of novel endoscopic instruments is essential to reduce trauma in visceral surgery. However, endoscopic device development is hampered by challenges in respecting the dimensional restrictions, due to the narrow access route, and by achieving adequate force transmission. As the overall goal of our research is the development of a patient adaptable, endoscopic anastomosis manipulator, biomechanical and size-related characterization of gastrointestinal organs are needed to determine technical requirements and thresholds to define functional design and load-compatible dimensioning of devices. METHODS: We built an experimental setup to measure colon tissue compression piercing forces. We tested 54 parameter sets, including variations of three tissue fixation configurations, three piercing body configurations (four, eight, twelve spikes) and insertion trajectories of constant velocities (5 mms-1, 10 mms-1,15 mms-1) and constant accelerations (5 mms-2, 10 mms-2, 15 mms-2) each in 5 samples. Furthermore, anatomical parameters (lumen diameter, tissue thickness) were recorded. RESULTS: There was no statistically significant difference in insertion forces neither between the trajectory groups, nor for variation of tissue fixation configurations. However, we observed a statistically significant increase in insertion forces for increasing number of spikes. The maximum mean peak forces for four, eight and twelve spikes were 6.4 ± 1.5 N, 13.6 ± 1.4 N and 21.7 ± 5.8 N, respectively. The 5th percentile of specimen lumen diameters and pierced tissue thickness were 24.1 mm and 2.8 mm, and the 95th percentiles 40.1 mm and 4.8 mm, respectively. CONCLUSION: The setup enabled reliable biomechanical characterization of colon material, on the base of which design specifications for an endoscopic anastomosis device were derived. The axial implant closure unit must enable axial force transmission of at least 28 N (22 ± 6 N). Implant and applicator diameters must cover a range between 24 and 40 mm, and the implant gap, compressing anastomosed tissue, between 2 and 5 mm.