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.

[Fulfillment of basic needs of the Moroccan female immigrant population in Arteixo]. / Satisfacción de las necesidades básicas en la población inmigrante femenina Marroquí en Arteixo.

Although some years ago the Moroccan immigrant population was mostly male, the number of women is increasing every day. This research is focused on this group, and has the following objectives: to know how emigration affects the fulfillment of Virginia Henderson's basic needs; what transformations and adaptations must be adopted in order to fulfill them; and what reinterpretations and strategies are implemented in order to minimize the impact of culture shock. A qualitative study was performed from 2004-2005 by means of semi-structured interviews to 20 Muslim immigrant women in a municipality of Galicia (Spain), and showed that for Muslim people, everything is regulated by religion, so the necessities affected are strongly related with the need of acting according to one's values and beliefs. Therefore, valuing the referred need provides fundamental data in order to direct the activities towards keeping and recovering health.

Satisfacción de las necesidades básicas en la población inmigrante femenina Marroquí en Arteixo / Satisfação das necessidades básicas na populaçao imigrante feminina marroquina em Arteixo / Fulfillment of basic needs of the moroccan female immigrant population in Arteixo

Aunque hace unos años la población inmigrante marroquí era en su mayor parte masculina, cada día aumenta el número de mujeres, colectivo del que se ocupa este trabajo. Conocer cómo afecta la emigración en la satisfacción de las necesidades básicas de Virginia Henderson, qué transformaciones y adaptaciones se tienen que realizar para satisfacerlas y qué reinterpretaciones y estrategias se ponen en marcha para minimizar el impacto del choque cultural. Durante un año 2004-2005 hemos realizado una investigación cualitativa mediante entrevistas semiestructuradas a 20 mujeres musulmanas inmigrantes en un municipio de Galicia (España). En la persona musulmana, toda su vida está regulada por la religión, por lo que las necesidades afectadas están estrechamente relacionadas con la necesidad de actuar según valores y creencias. Por ello, la valoración de dicha necesidad aporta datos fundamentales para orientar las actividades dirigidas a mantener y recuperar la salud.

Embora a população imigrante marroquina seja eminentemente masculina, atualmente é cada dia maior o número de mulheres. E é neste coletivo que se concentra este estudo, cujos objetivos são: saber como a emigração afeta a satisfação das Necessidades Básicas de Virginia Henderson, que transformações e adaptações tem que se realizar para satisfazê-las, e que reinterpretações e estratégias são postas em prática para minimizar o impacto do choque cultural. Para isso se fez uma investigação qualitativa mediante entrevistas semiestruturadas realizadas durante o período de 2004 - 2005, que nos mostra que, na pessoa muçulmana, toda a sua vida está dirigida pela religião, pelo que as necessidades afetadas estão estritamente relacionadas com a necessidade de atuar segundo os valores e crenças. Por isso, a valorização de tal necessidade aponta dados fundamentais para orientar as atividades dirigidas a manter e recuperar a saúde.

Although some years ago the Moroccan immigrant population was mostly male, the number of women is increasing every day. This research is focused on this group, and has the following objectives: to know how emigration affects the fulfillment of Virginia Henderson's basic needs; what transformations and adaptations must be adopted in order to fulfill them; and what reinterpretations and strategies are implemented in order to minimize the impact of culture shock. A qualitative study was performed from 2004-2005 by means of semi-structured interviews to 20 Muslim immigrant women in a municipality of Galicia (Spain), and showed that for Muslim people, everything is regulated by religion, so the necessities affected are strongly related with the need of acting according to one's values and beliefs. Therefore, valuing the referred need provides fundamental data in order to direct the activities towards keeping and recovering health.