Persistence, effectiveness and safety of ustekinumab and vedolizumab therapy for complex perianal fistula in Crohn's disease: The HEAL study from GETECCU.

BACKGROUND: The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety of these drugs in this context. METHODS: Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians' assessment. RESULTS: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab. CONCLUSION: Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles.

Results of implementation of a fast track pathway for diagnosis of colorectal cancer.

INTRODUCTION: fast track pathways for diagnosis of cancer intend to decrease delays in diagnosis and treatment of cancer. It is recommended to initiate treatment in a period no longer than 30 days since admission in these circuits. AIMS: to know the characteristics and fluency of our Fast Track Diagnostic Pathway (FTDP) for Colorectal Cancer (CRC), with special attention to those patients selected for surgical treatment as a first choice. MATERIAL AND METHOD: all patients who entered the FTDP for CRC during a period of 2 years (2008-2009) were analyzed as well as the rest of patients also diagnosed with CRC but never seen in the FTDP. RESULTS: of the 316 patients referred to the FTDP only 78 (24.7%) were diagnosed as having some kind of cancer derived from the digestive system. At the end 61 patients (19.3%) were diagnosed with CCR. The time interval from entry into the FTDP to the first hospital visit was 3 days (range 1-8), and the interval until colonoscopy was performed was 11.5 days (range 1-41). Fourteen (41.1%) of those patients chosen for surgery were operated on in a period lesser than 30 days while 28 patients (82.3%) underwent surgery before day 45 since admission into the circuit. CONCLUSIONS: though the functioning of the FTDP is acceptable, any increase in number of patients can generate delays. For this reason it is advisable to have a team to assure a good functioning of the FTDP. A proper follow-up of the whole process will possibly avoid unnecessary delays and it will improve coordination of the different phases of the fast track pathway and treatment. As the diagnostic outcome is poor it is mandatory to implement alternatives programs like screening of asymptomatic population, allowing an early detection of this condition.

Caloric intake capacity as measured by a standard nutrient drink test helps to predict weight loss after bariatric surgery.

BACKGROUND: Instruments that enable to select individuals that will benefit most from bariatric surgery (BS) are necessary to increase its cost-efficiency. Our goal was to assess if intake capacity, measured with a standardized test, predicts response to BS. METHODS: Patients with criteria for BS were randomly allocated to laparoscopic gastric bypass (LRYGB) or sleeve gastrectomy (LSG). We measured caloric intake capacity before and 1 year after surgery using a standardized nutrient drink test. We evaluated if pre-surgery satiation could predict satiation and weight loss (%) 1 year after surgery using multiple regression modeling. Descriptive statistics are given as mean ± SD. RESULTS: Fourteen women (48 ± 9 years old, BMI 41 ± 3 kg/m(2)) were evaluated before and 11 ± 2.6 months after surgery (seven LRYGB, seven LSG). Caloric intake capacity diminished after surgery (-950 ± 85 kcal on average [70 ± 8 % decrease over basal intake capacity]; p=0.002) and similarly in both LRYGB (72 ± 7 % decrease) and LSG groups (68 ± 8 % decrease); p=0.5. There was a significant weight reduction after surgery (-32 ± 10 kg [30 ± 8 % of total basal weight]) with a mean post-surgery BMI of 29 ± 2 kg/m(2). The best predictive model of weight loss (%) after surgery (R (2)=89 %, p=0.0009) included: BMI (p=0.0004), surgery type (p=0.01) and pre-surgery intake capacity (p=0.006). Weight loss was higher in heavier patients and those undergoing LRYGB. Patients with higher intake capacity had a poorer outcome independently of basal BMI and surgery type. CONCLUSIONS: Caloric intake capacity, as measured by a standard nutrient drink test, helps to predict weight loss after bariatric surgery. This test might be useful in algorithms of obesity treatment decision.