Administration of an Anal Bulking Agent With Polyacrylate-Polyalcohol Copolymer Particles Versus Endoanal Electrical Stimulation With Biofeedback for the Management of Mild and Moderate Anal Incontinence: A Randomized Prospective Study.

BACKGROUND: There are few treatment options for mild-to-moderate anal incontinence with isolated internal anal sphincter defects or anal incontinence without muscle damage. Less-invasive techniques are generally favored. OBJECTIVE: To compare the results between the use of an anal bulking agent with polyacrylate-polyalcohol copolymer particles and endoanal electrical stimulation with biofeedback in patients with mild or moderate anal incontinence. DESIGN: This was a prospective parallel-group, single-institution, randomized clinical trial. SETTINGS: This study was conducted in an ambulatory setting at the Colorectal Physiology Service of the Hospital das Clinicas, Medical School, University of Sao Paulo. PATIENTS: This study included patients who had anal incontinence for >6 months with isolated internal anal sphincter muscle damage or absence of anatomical defects in the anorectal sphincter complex. INTERVENTIONS: Anal bulking agent and endoanal electrical stimulation with biofeedback. MAIN OUTCOME MEASURES: The primary outcome measure was the Cleveland Clinic Florida Fecal Incontinence Score, and the secondary outcome measures included quality of life, recommended procedures, and anorectal manometry. RESULTS: There were no significant between-group differences in mean age, sex, BMI, stool consistency, and Cleveland Clinic Florida Fecal Incontinence Score (p = 0.20) at baseline. After 12 months, the Cleveland Clinic Florida Fecal Incontinence Score was found to be significantly improved in patients treated with the bulking agent compared to those treated with electrical stimulation (mean, 6.2 vs 9.2; p = 0.002), though the anorectal manometry parameters did not change significantly. The mean anal Cleveland Clinic Florida Fecal Incontinence Score declined by 4.2 points in the bulking agent group compared to a decline of 0.8 in the electrical stimulation group (mean difference in decline: 3.4 points; 95% CI, 1.2-5.5). Quality-of life evaluation showed similar results between groups comparing baseline parameters with 12-month follow-up. LIMITATIONS: The short follow-up period of 1 year, atypical method of biofeedback, and unmatched baseline in some of the quality-of-life scales between the 2 groups limited this study. CONCLUSIONS: In patients with mild or moderate anal incontinence, the Cleveland Clinic Florida Fecal Incontinence Score significantly improved in the bulking agent with polyacrylate-polyalcohol copolymer group compared with the endoanal electrical stimulation with biofeedback group. See Video Abstract at http://links.lww.com/DCR/B938. ADMINISTRACIN DE UN GEL ANAL CON PARTCULAS DE COPOLMERO DE POLIACRILATOPOLIALCOHOL VERSUS ESTIMULACIN ELCTRICA ENDOANAL CON EJERCICIOS ANALES BIOFEEDBACK PARA EL MANEJO DE LA INCONTINENCIA ANAL LEVE Y MODERADA UN ESTUDI PROSPECTIVO ALEATORIZADO: ANTECEDENTES:Hasta la fecha, existen pocas opciones de tratamiento para la incontinencia anal de leve a moderada con defectos aislados del esfínter anal interno o la incontinencia anal sin daño muscular. Por lo general, se prefieren técnicas menos invasivas.OBJETIVO:El objetivo fue comparar los resultados entre el uso de un gel intra-anal con partículas de copolímero de poliacrilato-polialcohol y la estimulación eléctrica endoanal con ejercicios anales en pacientes con incontinencia anal leve o moderada.DISEÑO:Este fue un ensayo clínico aleatorio prospectivo de grupos paralelos, de una institución, realizado en cuatro etapas: base, procedimientos, postratamiento temprano y tardío.AJUSTE:Este estudio se realizó en el ambulatorio de Fisiología Colorrectal del Servicio de Coloproctología del Hospital das Clínicas, Facultad de Medicina, Universidad de São Paulo.PACIENTES:Paciente con incontinencia anal con más de 6 meses, con daño muscular aislado del esfínter anal interno o ausencia de defectos anatómicos en el esfínter anorrectal.INTERVENCIONES:Las intervenciones incluyeron la inyección del gel intra-anal y estimulación eléctrica endoanal con ejercicios anales.PRINCIPALES MEDIDAS DE RESULTADO:Indice de incontinencia fecal (Cleveland Clinic Florida), Indice de calidad de vida, los procedimientos recomendados y la manometría anorrectal.RESULTADOS:No hubo diferencias significativas entre los grupos en cuanto a la edad media, el sexo, el índice de masa corporal, la consistencia de las heces y la puntuación de incontinencia fecal (p = 0,20) al inicio del estudio. Después de 12 meses, la puntuación de incontinencia fecal mejoró significativamente en los pacientes tratados con el el gel intra-anal (media = 6,2) en comparación con los tratados con estimulación eléctrica (media = 9,2; p = 0,002), aunque los parámetros de manometría anorrectal no mejoraron significativamente. La puntuación anal media de incontinencia fecal disminuyó 4,2 puntos en el grupo del Gel intra-anal en comparación con 0,8 en el grupo de estimulación eléctrica (diferencia media en la disminución: 3,4 puntos; IC del 95%: 1,2 a 5,5). La evaluación de la calidad de vida mostró resultados similares entre los grupos que compararon los parámetros iniciales con un seguimiento de 12 meses.LIMITACIONES:Breve período de seguimiento de un año, métodos diferentes de ejercicios anales y línea de base sin igual en algunas de las escalas de calidad de vida entre los dos grupos.CONCLUSIONES:En pacientes con incontinencia anal leve y moderada, la puntuación de incontinencia fecal mejoró significativamente en el grupo de gel intra-anal con copolímero de poliacrilato-polialcohol en comparación con la estimulación eléctrica endoanal. Consulte Video Resumen en http://links.lww.com/DCR/B938. (Traducción- Dr Leonardo Alfonso Bustamante-Lopez).

Integrated care pathway for rectal cancer treatment: health care resource utilization, costs, and outcomes.

AIM: Managed Flow C20 (MFC20) is an integrated care pathway (ICP) for rectal cancer implemented at a public teaching hospital. This study aims to quantify resource utilization and estimate direct costs and outcomes associated with the use of this ICP. METHODS: We evaluated consecutive rectal cancer patients treated with neoadjuvant chemoradiotherapy (nCRT) followed by surgery, comparing the period before the ICP implementation (Pre-MFC20 group) and after (MFC20 group). We assessed times between treatment steps and quantified the resources utilized, as well as their costs. RESULTS: There were 112 patients in the Pre-MFC20 group and 218 in the MFC20 group. The mean treatment intervals were significantly shorter in the MFC20 group - from the first medical consultation to nCRT (48.3 vs. 87.5 days; P < 0.001); and from nCRT to surgery (14.8 vs. 23.0 weeks; P < 0.001) - as was the mean total treatment time (192.0 vs. 290.2 days; P < 0.001). Oncology consultations, computed tomography, MRI, and radiotherapy sessions were utilized more frequently in the Pre-MFC20 group (P < 0.001). The median per-patient cost was US$11 180.92 in the Pre-MFC20 group, compared with US$10 412.88 in the MFC20 group (P = 0.125). Daily hospital charges and consultations were the major determinants of the total cost of the treatment. There was no statistical difference in overall survival in the time periods examined. CONCLUSION:: Implementation of a rectal cancer ICP reduced all treatment intervals and promoted rational utilization of oncology consultations and imaging, without increment in per-patient costs or detrimental effects in overall survival.

Pathologic Complete Response in Rectal Cancer: Can We Detect It? Lessons Learned From a Proposed Randomized Trial of Watch-and-Wait Treatment of Rectal Cancer.

BACKGROUND: Chemoradiotherapy has the potential to downsize and downstage tumors before surgery, decrease locoregional recurrence, and induce a complete sterilization of tumor cells for middle and low locally advanced rectal cancer. A watch-and-wait tactic has been proposed for patients with clinical complete response. OBJECTIVE: The purpose of this study was to verify our ability to identify complete clinical response in patients with rectal cancer based on clinical and radiologic criteria. DESIGN: This was a prospective study. SETTINGS: The study was conducted at a single institution, in the setting of a watch-and-wait randomized trial. PATIENTS: Consecutive patients with stage T3 to T4N0M0 or T(any)N+M0 cancer located within 10 cm from anal verge or T2N0 within 7 cm from anal verge were included in the study. Patients were staged and restaged 8 weeks after completion of chemoradiation (5-fluorouracil, 5040 cGy) by digital examination, colonoscopy, pelvic MRI, and thorax and abdominal CT scans. MAIN OUTCOME MEASURES: Clinical and radiologic judgments of tumor response were compared with pathologic response of patients treated by total mesorectal excision or clinical follow-up of patients selected for nonoperative treatment. RESULTS: A total of 118 patients were treated. Six patients were considered clinic complete responders (2 randomly assigned for surgery (1 ypT0N0 and 1 ypT2N0) and 4 patients randomly assigned for observation (3 sustained clinic complete response and 1 had tumor regrowth)). The 112 clinic incomplete responders underwent total mesorectal excision, and 18 revealed pathologic complete response. These 18 patients were not considered complete responders at restaging because they presented at least 1 of the following conditions: mucosal ulceration and/or deformity and/or substenosis of rectal lumen at digital rectal examination and colonoscopy (n = 16), ymrT1 to T4 (n = 16), ymrN+ (n = 2), involvement of circumferential resection margin on MRI (n = 3), extramural vascular invasion on MRI (n = 4), MRI tumor response grade 2 to 4 (n = 15), and pelvic side wall lymph node involvement on MRI (n = 1). Sensitivity for identification of ypT0N0 or sustained clinic complete response was 18.2%. LIMITATIONS: This study has a short follow-up and small sample size. Radiologists who reviewed the restaging examination were not blinded to the pretreatment stage. Only 1 radiologist read the images of each patient. CONCLUSIONS: Evaluation of clinic complete response according to current adopted criteria has low sensitivity because pathologic complete response more frequently presented as clinic incomplete response (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A221).

Selection of top 10 quality indicators for nutrition therapy.

BACKGROUND: The identification of useful quality indicators for nutrition therapy (QINTs) is of great interest and a challenge. This study attempted to identify the 10 QINTs that best suit the practice of quality control in nutrition therapy (NT) by evaluating the opinion of experts in NT with the use of psychometric techniques and statistical tools. METHODS: Thirty-six QINTs available for clinical application in Brazil were assessed in 2 distinct phases. In phase 1, 26 nutrition experts ranked QINTs by scoring 4 attributes (utility, simplicity, objectivity, low cost) to assess each QINT on a 5-point Likert scale. The top 10 QINTs were identified from the 10 best scores obtained, and the reliability of expert opinion for each indicator was assessed by Cronbach's α. In phase 2, experts provided feedback regarding the selected top 10 QINTs by answering 2 closed questions. RESULTS: The top 10 QINTs, in descending order, are the frequency of nutrition screening of hospitalized patients, diarrhea, involuntary withdrawal of enteral feeding tubes, feeding tube obstruction, fasting longer than 24 hours, glycemic dysfunction, estimated energy expenditure and protein needs, central venous catheter infection, compliance of NT indication, and frequency of application of subjective global assessment. Opinions were consistent among the interviewed experts. During feedback, 96% of experts were satisfied with the top 10 QINTs, and 100% had considered them in accordance with their previous opinion. CONCLUSION: The top 10 QINTs were identified according to their usefulness in clinical practice by obtaining adequate agreement and representativeness of opinion of nutrition experts.

Pregnancy nutritional indices and birth weight after Roux-en-Y gastric bypass.

BACKGROUND: Maternal metabolic profile and nutritional course of pregnancy after bariatric interventions is incompletely known. Their impact on birth weight has also not been hitherto addressed. Aiming to document such variables, a retrospective study was undertaken. METHODS: Women previously submitted to silastic ring Roux-en-Y gastric bypass, who conceived after 0-5 years (n = 14), were investigated. Intake of selected macro- and micronutrients, representative laboratory measurements, and correlation of these findings with birth weight and time to conception was documented. RESULTS: Mean calorie intake was restricted to about 1,800 kcal/day. Protein (71 +/- 17 g/day) and supplementary iron (60 mg/day) were barely adequate, and calcium and vitamin B(12) did not meet current recommendations, only folic acid being optimal. Biochemical monitoring reflected these inconsistencies, with occasional low values for serum albumin (4.1 +/- 0.4 g/dL), hemoglobin (11.4 +/- 1.5 g/dL), iron (78 +/- 50 mug/dL) and vitamin B(12) (193 +/- 102 pg/mL) but not folate. Lipids, glucose, and uric acid were much better than before the anti-obesity intervention. Reduced plasma lipids, glucose, and uric acid were associated with larger birth weight, albeit within the normal range. CONCLUSIONS: (1) Anemia as well as additional nutritional deficits during pregnancy were not totally eliminated, despite dietary guidance and micronutrient supplementation; (2) alleviation of metabolic comorbidities was demonstrated, and improved normalization predicted higher birth weight; (3) energy and folate intake was sufficient, but other nutrients probably did not reach ideal levels; (4) recent dietary guidelines for this population represent a step forward, but additional studies are needed.

Systemic inflammation in morbidly obese subjects: response to oral supplementation with alpha-linolenic acid.

BACKGROUND: Morbidly obese patients frequently display asymptomatic chronic activation of acute phase response, with potentially adverse metabolic and cardiovascular consequences. Nutritional preparations to improve this phenomenon have rarely been administered. Aiming to investigate the supplementation of flaxseed flour, a source of omega-3 fatty acids, a prospective randomized double-blind cross-over study was designed. METHODS: Outpatient obese subjects (n=41) were clinically and biochemically screened, and results for 24 randomized subjects are shown. Age was 40.8 +/- 11.6 years (83.3% females) and body mass index (BMI) was 47.1 +/- 7.2 kg/m2. Flaxseed flour (Farinha de Linhaca Dourada LinoLive, Cisbra, Brazil) in the amount of 30 g/day (5 g of alpha-linolenic acid - omega-3) and an equal mass of placebo (manioc flour) were administered for 2 weeks each. Variables included general biochemical investigation, white blood cell count (WBC), C-reactive protein (CRP), serum amyloid A (SAA) and fibronectin. RESULTS: No intolerance was registered. Body weight and general biochemical indices remained stable. Initial CRP and SAA were elevated (13.7 +/- 9.9 and 17.4 +/- 8.0 ). WBC (8100 +/- 2100/mm3) and fibronectin (463.2 +/- 61.3 mg/dL) were acceptable but in the upper normal range. Corresponding findings after supplementation of flaxseed were 10.6 +/- 6.2 mg/L, 14.3 +/- 9.2 mg/L, 7300 +/- 1800/mm3 and 412.8 +/- 38.6 respectively (P<0.05). No change during the control period regarding baseline occurred when placebo was randomized to be given first; however, when it followed omega-3 supplementation, CRP and SAA recovered, whereas WBC and fibronection remained depressed during those 2 weeks (7500 +/- 2100/mm3 and 393.2 +/- 75.8 mg/dL, P<0.05). CONCLUSIONS: 1) Various inflammatory markers were elevated in the studied population, although not necessarily exceeding the normal range; 2) Significant reduction could be demonstrated; 3) Some persistent effects of flaxseed supplement 2 weeks after discontinuation were observed.

Economic study in surgical patients of a new model of nutrition therapy integrating hospital and home vs the conventional hospital model.

BACKGROUND: Dehospitalization is a trend in the health sector justified by humanitarian and socials aspects for the patient and relatives. From the financing institutions' perspective, whether government or third party, the positive results arise from an optimization of hospital bed use and favorable cost-benefit ratio. The "integrated home-hospital" model was created with the purpose of optimization of resources without detriment to the patients' nutritional care. The objective of this study was an economic evaluation regarding nutrition therapy of the integrated hospital-home model in comparison with an exclusively hospital model. METHODS: A retrospective controlled study, paired (age, sex, disease, and surgical procedure), was performed on 56 digestive surgery patients divided into 2 groups: study (SG; n = 30) and control (CG; n = 26). The data collected included total expenses with hospitalization, nutritional benefits, minimization cost analysis, cost-effectiveness ratio analysis, cost-benefit ratio analysis, hospital length of stay, and hospital-bed optimization. RESULTS: The patients from the SG achieved the same nutritional benefits as those in the CG, but with expenses 3 times lower (median Brazil Reals (R)$3237.18 vs R$8647.93; p < .05). The new model resulted in economic benefit to the institution, as shown by the cost-effectiveness ratio, mainly resulting from the savings of the days of hospitalization avoided. The cost-benefit ratio showed an important savings per patient for the institution (US $3100). CONCLUSIONS: The home-hospital model also reduced length of hospital stay 2.7 times and optimized the hospital bed usage, as it promoted higher hospital-bed rotation (3 times greater).

Valor preditivo da quimiosensibilidade in vitro na quimioterapia do câncer gástrico avançado / Preditive value of the chemosensitivy test in the chemoterapy for advanced gastric cancer

Racional - Existem controvérsias em relação ao emprego de quimioterapia em pacientes com câncer gástrico. No sentido de se tentar identificar os que poderiam se beneficiar com este tratamento, surgiram os testes de quimiosensibilidade. Objetivo - Avaliar a eficácia de drogas quimioterápicas através do teste in vitro, denominado MTT [3-(4,5 dimetiltiazol-2yl)-2-5-difenil-2h tetrazolato de bromo], sobre células tumorais de pacientes com câncer gástrico avançado, submetidos a tratamento cirúrgico, além de correlacionar os resultados do teste com aspectos anatomopatológicos, estágio, resposta clínica ao tratamento quimioterápico e sobrevida. Material e Métodos - O teste foi realizado em 112 pacientes com câncer gástrico avançado submetidos a tratamento cirúrgico, estudando-se in vitro as seguintes drogas: mitomicina C, doxorrubicina, cisplatina e 5-fluorouracil. Resultados - Os índices de eficácia observados foram: 12,5% para a mitomicina, 6,3% para a doxorrubicina, 13,4% para a cisplatina e 5,4% para o 5-fluorouracil. O teste demostrou sensibilidade de 86%, especificidade de 76%, valor preditivo positivo de 40%, valor preditivo negativo de 97% e acurácia de 78%, quando comparado com resultados clínicos de tratamento quimioterápico que incluía essas drogas. A ação dos quimioterápicos estudados não teve relação com idade, sexo ou estádio anatomopatológico. As células dos tumores diferenciados foram sensíveis à ação das drogas estudadas. Conclusões - No presente estudo, o teste de sensibilidade in vitro como fator preditivo da resposta à quimioterapia, parece ser eficiente em termos de sobrevida somente quando a quimioterapia é realizada em pacientes submetidos a tratamento cirúrgico curativo. Novos métodos juntamente com a descoberta de agentes quimioterápicos mais efetivos, associados à ressecção radical do tumor, poderão trazer novos horizontes para o tratamento do câncer gástrico avançado.