Endolumenal colon occlusion device for transanal and transrectal surgery--a porcine feasibility study.

Purpose: Although several studies have demonstrated the feasibility of transrectal natural orifice translumenal endoscopic surgery (NOTES), its clinical application has been hindered by concerns regarding potential infectious complications. The aim of this study was to evaluate the feasibility of a newly developed device for endolumenal colon occlusion (ColoShield) in an acute porcine model.

Methods: The principle of the ColoShield device is based on two balloons, with negative pressure in between. The ColoShield device and a gauze tamponade as a control group were evaluated in a non-survival study on 16 pigs. The efficacy of the occlusion system in establishing a leak-proof pneumorectum and in sealing the colon from proximal (watertight sealing) was tested by a standardized study course. Finally, the colon/rectum was explanted for macroscopic and microscopic examination.

Results: A 20-mmHg leak-proof pneumorectum over a period of 10 min could be achieved in seven of eight (87 %) animals with the ColoShield device and in none of eight (0 %) animals with gauze tamponade (p < 0.001). In the watertight sealing test, mean intracolonic pressures of 23.5 ± 18.1 (0-53) mmHg using the ColoShield device and 0 ± 1.1 (0-3) mmHg using gauze tamponade (p = 0.003) were documented proximal to the occlusion system before a leakage occurred. Macroscopic and histopathological examinations revealed no significant impairment of the colon specimen in either group.

Conclusions: ColoShield proved to be a safe and effective device for a reversible endolumenal colon occlusion. Further studies should evaluate its impact on procedural sterility during transrectal NOTES.