Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device.

INTRODUCTION: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. METHODS: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. RESULTS: 16 patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic Mucosal Resection (EMR) (6.3%), Endoscopic Submucosal Dissection ESD (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. In no case did rectal perforation or major complications requiring urgent reintervention occur. As for the level of reproducibility, safety, level of satisfaction with the device and evaluation of the blister, the evaluation on a scale of 0-10 (9.43, 9.71, 9.29 and 9.50 respectively). All the investigators have previous experience with transanal devices. CONCLUSIONS: The study demonstrates the efficacy and safety of UNI-VEC® for the treatment of rectal lesions. It will facilitate the implementation of hybrid procedures that seek to solve the limitations of pure endoscopic techniques by allowing the concomitant use of conventional laparoscopic and robotic instrumentation with the flexible endoscope.

[Immunity against hepatitis A virus in patients with chronic hepatitis C]. / Inmunidad frente al virus de la hepatitis A en los pacientes con infección crónica por el virus de la hepatitis C.

BACKGROUND AND OBJECTIVE: Because of high fatality rate associated with acute infection by hepatitis A virus (HAV) in chronic hepatitis C patients, it is of interest to know the prevalence of immunization against HAV in these patients. PATIENTS AND METHOD: Immunoglobulin G (IgG) IgG HAV antibodies (IgG anti-HAV) were determined in 313 hepatitis C virus antibodies (anti-HCV) positive patients and in 313 anti-HCV negative subjects (control group). Several epidemiological factors were recorded (age, sex, rural vs urban precedence, tattoos, parenteral drugs use, alcohol consumption and surgery). RESULTS: The prevalence of IgG anti-HAV was identical in both groups: 81.2%. However, in those younger than 41 years, this prevalence was greater in those anti-HCV positive than in the control group. Parenteral drugs use and tattoos were more frequent in the first group. The presence of IgG anti-HAV was associated with age and the rural origin in both groups. CONCLUSIONS: The prevalence of IgG anti-HAV increases with age, and is more frequent in individuals with rural origin. It was also greater in young anti-HCV positive patients, when compared with controls of the same age. This finding can be due to the poor standards of hygiene probably associated with some practices more common in this population, such as parenteral drugs use, tattoos and others.