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.

Safety and risk factors for difficult endoscopist-directed ERCP sedation in daily practice: a hospital-based case-control study.

BACKGROUND: There are limited data concerning endoscopist-directed endoscopic retrograde cholangiopancreatography deep sedation. The aim of this study was to establish the safety and risk factors for difficult sedation in daily practice. PATIENTS AND METHODS: Hospital-based, frequency matched case-control study. All patients were identified from a database of 1,008 patients between 2014 and 2015. The cases were those with difficult sedations. This concept was defined based on the combination of the receipt of high-doses of midazolam or propofol, poor tolerance, use of reversal agents or sedation-related adverse events. The presence of different factors was evaluated to determine whether they predicted difficult sedation. RESULTS: One-hundred and eighty-nine patients (63 cases, 126 controls) were included. Cases were classified in terms of high-dose requirements (n = 35, 55.56%), sedation-related adverse events (n = 14, 22.22%), the use of reversal agents (n = 13, 20.63%) and agitation/discomfort (n = 8, 12.7%). Concerning adverse events, the total rate was 1.39%, including clinically relevant hypoxemia (n = 11), severe hypotension (n = 2) and paradoxical reactions to midazolam (n = 1). The rate of hypoxemia was higher in patients under propofol combined with midazolam than in patients with propofol alone (2.56% vs. 0.8%, p < 0.001). Alcohol consumption (OR: 2.674 [CI 95%: 1.098-6.515], p = 0.030), opioid consumption (OR: 2.713 [CI 95%: 1.096-6.716], p = 0.031) and the consumption of other psychoactive drugs (OR: 2.015 [CI 95%: 1.017-3.991], p = 0.045) were confirmed to be independent risk factors for difficult sedation. CONCLUSIONS: Endoscopist-directed deep sedation during endoscopic retrograde cholangiopancreatography is safe. The presence of certain factors should be assessed before the procedure to identify patients who are high-risk for difficult sedation.

[Referrals to a gastroenterology outpatient clinic from primary care: evaluation of two programs]. / Derivación a las consultas de gastroenterología desde atención primaria: evaluación de dos programas.

OBJECTIVES: To analyze the effect of implementing a high-resolution clinic (HRC) and an increasing resolution capacity program in primary care (IRCPPC) for referrals to a gastroenterology outpatient clinic from primary care and the resources used. METHODS: A retrospective and observational study based on a review of referral sheets and databases was performed. We analyzed the number and reason for referrals, delay times and resource consumption in two periods: before (first 4 months of 2007) and after (first 4 months of 2009) the launch of the IRCPPC and HRC. RESULTS: In the first and second periods, 881 and 1076 patients, respectively, referred from primary health care were evaluated in the gastroenterology clinic, with a decrease in the delay time in the second period (80.8 ± 64.34 days vs 36.1 ± 29.12 days, p < 0.001). The most frequent reasons for referral were dyspepsia (27.7%), high-risk of colorectal cancer (17.1%), disturbance of bowel rhythm (18.2%), abdominal pain (16%), and gastroesophageal reflux (11.2%), with no differences between the two periods. Although delay times until the first visit (10.8 ± 9.03 days vs 42.8 ± 28.67 days, p < 0.001) and until discharge (39.6 ± 80.65 days vs 128.6 ± 135.34 days, p < 0.001) were lower in referrals to the HRC, the number of visits (3.6 ± 2.20 vs 3.2 ± 1.95, p = 0.015) and the cost of referrals (592.7 ± 421.50 € vs 486.0 ± 309.66 €, p < 0.001) was higher. CONCLUSIONS: In the study period the number of referrals increased, while the delay time decreased. Although the HRC reduces delay times, it is associated with an increase in health resource use.

[Effect of the implementation of a program to improve referrals by primary care on appropriateness and wait times in endoscopic examinations]. / Efecto de la implantación de un programa de mejora de la capacidad resolutiva de atención primaria en la adecuación y la demora de las exploraciones endoscópicas.

INTRODUCTION: Within a program to improve referrals by primary care (PC) in Ourense (Spain), we implemented practice guidelines on dyspepsia and rectal bleeding. Our aim was to evaluate the reasons for referral to endoscopy, the appropriateness of these referrals, and wait times. MATERIAL AND METHODS: We performed a retrospective cohort study in the Ourense health area between February 2009 and January 2010. The endoscopies performed with the indications of dyspepsia and rectal bleeding requested directly from PC were compared with those referred initially to specialist care (SC). The reasons for the referral, the priority of the endoscopy, compliance with the protocol, endoscopic finding and the wait time from referral were gathered. RESULTS: During the period analyzed, 158 upper gastrointestinal endoscopies (SC: 121; PC: 37) and 243 colonoscopies (SC: 193; PC: 50) were performed with the indications of dyspepsia and rectal bleeding. Among endoscopies, 34.5% and 77.7% were requested with high priority from PC and SC, respectively (p<0.001). The criteria for referral were met in 86.5% of upper gastrointestinal endoscopies and in 82% of colonoscopies requested from PC. No differences were found in endoscopic findings. The median wait time from referral was lower in upper gastrointestinal endoscopy (PC: 105±5.5 days, SC: 174±17.8 days; p: 0.003) and colonoscopies (PC: 101±11.8 days, SC: 187±9.6 days; p<0.001) referred from PC. CONCLUSIONS: The use of the program for improved referrals by PC reduces wait times. The examinations requested complied with the indications.