SEVTAR-A multicenter randomized controlled trial to investigate the impact of prophylactic endoluminal placed vacuum sponge for prevention of anastomotic leakage after low rectal resections.

Background: Low anterior resection for rectal cancer is commonly associated with a diverting stoma. In general, the stoma is closed 3 months after the initial operation. The diverting stoma reduces the rate of anastomotic leakage as well as the severeness of a potential leakage itself. Nevertheless, anastomotic leakage is still a life-threatening complication and might reduce the quality of life in the short and long term. In case of leakage, the construction can be converted into a Hartmann situation or it could be treated by endoscopic vacuum therapy or by leaving the drains. In recent years, endoscopic vacuum therapy has become the treatment of choice in many institutions. In this study, the hypothesis is to be evaluated, if a prophylactic endoscopic vacuum therapy reduces the rate of anastomotic leakage after rectal resections. Methods: A multicenter parallel group randomized controlled trial is planned in as many as possible centers in Europe. The study aims to recruit 362 analyzable patients with a resection of the rectum combined with a diverting ileostoma. The anastomosis has to be between 2 and 8 cm off the anal verge. Half of these patients receive a sponge for 5 days, and the control group is treated as usual in the participating hospitals. There will be a check for anastomotic leakage after 30 days. Primary end point is the rate of anastomotic leakages. The study will have 60% power to detect a difference of 10%, at a one-sided alpha significance level of 5%, assuming an anastomosis leakage rate of 10%-15%. Discussion: If the hypothesis proves to be true, anastomosis leakage could be reduced significantly by placing a vacuum sponge over the anastomosis for 5 days. Trial registration: The trial is registered at DRKS: DRKS00023436. It has been accredited by Onkocert of the German Society of Cancer: ST-D483. The leading Ethics Committee is the Ethics Committee of Rostock University with the registration ID A 2019-0203.

Computed tomographic-dacryocystography (CT-DCG) of the normal canine nasolacrimal drainage system with three-dimensional reconstruction.

The aims of the study were (1) to quantify the influence of selected imaging parameters on the image quality (slice thickness, mAs, and beam orientation) defining optimal conditions for scan protocols and (2) to evaluate the benefits of the 3D reconstruction techniques for visualization of NDS structures in dogs. CT-DCG was performed bilaterally in 32 heads of dogs. CT transverse images were obtained using a combination of two slice thickness values (0.8 mm and 2 mm) and two mAs values (50 mAs and 300 mAs). Two beam projection orientations were also tested: transverse plane (perpendicular to the hard palate) and oblique to the hard palate. Three-dimensional images were obtained using Volume Rendering (VR). Transverse beam projection proved to be superior for the assessment of the inferior and superior lacrimal canaliculi and lacrimal sac. In this study, there was no statistical difference regarding mAs values (50 mAs and 300 mAs) and slice thickness values (0.8 mm and 2 mm). Three-dimensional images were helpful for the assessment of topographic relationship between nasolacrimal structures and cranial landmarks.