Long-term Evaluation of Fistulotomy and Immediate Sphincteroplasty as a Treatment for Complex Anal Fistula.

BACKGROUND: Fistulotomy with immediate sphincteroplasty is a technique that can heal fistulas and decrease fecal incontinence more effectively than fistulotomy alone, in selected patients. OBJECTIVE: We aimed to perform a long-term evaluation of fecal incontinence after fistulotomy and immediate sphincteroplasty in patients with complex anal fistula. DESIGN: This prospective study included patients undergoing fistulotomy and immediate sphincteroplasty for complex anal fistula from January 2000 to December 2010. SETTINGS: The study was conducted by 2 colorectal surgeons in the coloproctology unit of the General Hospital of Elche. PATIENTS: We included patients aged ≥18 years with complex anal fistulas of cryptoglandular origin. MAIN OUTCOME MEASURES: Main outcomes were recurrence and continence after fistulotomy and immediate sphincteroplasty, according to fistula tract height and preoperative continence status. RESULTS: A total of 107 patients were included; 68.2% were men, with a mean age of 48 years and mean fistula duration of 12.8 months. The range and median follow-up period were 84 to 204 and 96 months. Thirty-seven fistulas were not primary. The overall healing rate was 84.1%. Primary fistulas healed by the end of follow-up in 58 (82.9%) of 70 patients; recurrent fistulas healed in 32 (86.5%) of 37; high tracts healed in 31 (83.8%) of 37, and nonhigh fistulas healed in 59 (84.3%) of 70. Male sex (OR = 0.66 (95% CI, 0.20-2.13); p > 0.05) and recurrent fistulas (OR = 0.43 (95% CI, 0.11-1.68); p > 0.05) could have a protective effect against postoperative fecal incontinence; however, more studies with larger sample sizes are necessary to confirm this result, whereas high fistulas showed a 4-fold increased risk of incontinence (range, 1.22-13.06; p < 0.01). One in 5 high-tracts patients experienced continence deterioration. LIMITATIONS: This was a prospective study, and randomized clinical trials with more patients and longer follow-up are needed to compare fistulotomy and immediate sphincteroplasty with other sphincter-preserving techniques. CONCLUSIONS: Fistulotomy and immediate sphincteroplasty are good options for treating complex anal fistulas, especially for recurrent fistulas, men, and patients with nonhigh tracts, with acceptable recurrence and incontinence rates. See Video Abstract at http://links.lww.com/DCR/B498. EVALUACIN A LARGO PLAZO DE LA FISTULOTOMA Y LA ESFINTEROPLASTIA INMEDIATA COMO TRATAMIENTO PARA LA FSTULA ANAL COMPLEJA: ANTECEDENTES:La fistulotomía y la esfinteroplastia inmediata es una técnica que puede curar las fístulas y disminuir la incontinencia fecal de manera más efectiva que la fistulotomía sola, en pacientes seleccionados.OBJETIVO:Nuestro objetivo fue realizar una evaluación a largo plazo de la incontinencia fecal después de la fistulotomía y la esfinteroplastia inmediata en pacientes con fístula anal compleja.DISEÑO:Este estudio prospectivo incluyó pacientes sometidos a fistulotomía y esfinteroplastia inmediata por fístula anal compleja, desde enero de 2000 hasta diciembre de 2010.ENTORNO CLINICO:El estudio fue realizado por dos cirujanos colorrectales de la Unidad de Coloproctología del Hospital General de Elche.PACIENTES:Se incluyeron pacientes ≥ 18 años con fístulas anales complejas de origen criptoglandular.PRINCIPALES MEDIDAS DE VALORACION:Los principales resultados fueron la recurrencia y la continencia después de la fistulotomía y la esfinteroplastia inmediata, de acuerdo con la altura del trayecto de la fístula y el estado de continencia preoperatoria.RESULTADOS:Se incluyeron un total de 107 pacientes; El 68,2% eran varones, con una edad media de 48 años y una duración media de la fístula de 12,8 meses. El rango y la mediana del período de seguimiento fue de 84-204 y 96 meses, respectivamente. Treinta y siete fístulas no fueron primarias. La tasa de curación general fue del 84,1%. Las fístulas primarias cicatrizaron al final del seguimiento en 58/70 (82,9%) pacientes; las fístulas recurrentes cicatrizaron en 32/37 (86,5%); los tractos altos cicatrizaron en 31/37 (83,8%) y las fístulas no altas cicatrizaron en 59/70 (84,3%). El sexo masculino (razón de posibilidades: 0,66 [0,20-2,13], p > 0,05) y las fístulas recurrentes (razón de posibilidades: 0,43 [0,11-1,68], p > 0,05) podrían tener un efecto protector contra la incontinencia fecal postoperatoria, sin embargo, más estudios con una muestra más grande son necesarios para confirmar este resultado. Fistulas altas mostraron un riesgo cuatro veces mayor de incontinencia ([1.22-13.06], p < 0.01). Uno de cada cinco pacientes con tractos altos experimentó un deterioro de la continencia.LIMITACIONES:Este fue un estudio prospectivo y se necesitan ensayos clínicos aleatorios con más pacientes y un seguimiento más prolongado para comparar la fistulotomía y la esfinteroplastia inmediata con otras técnicas de preservación del esfínter.CONCLUSIÓN:La fistulotomía y la esfinteroplastia inmediata son buenas opciones para el tratamiento de fístulas anales complejas, especialmente para fístulas recurrentes, varones y pacientes con tractos no altos, con tasas aceptables de recurrencia e incontinencia. Consulte Video Resumen en http://links.lww.com/DCR/B498.

Effect of home-based prehabilitation in an enhanced recovery after surgery program for patients undergoing colorectal cancer surgery during the COVID-19 pandemic.

BACKGROUND: Surgery remains the first curative treatment for colorectal cancer. Prehabilitation seems to attenuate the loss of lean mass in the early postoperative period. However, its long-term role has not been studied. Lockdown due to the COVID-19 pandemic has forced to carry out the prehabilitation program at home. This study aimed to assess the effect of home prehabilitation on body composition, complications, and hospital stay in patients undergoing oncological colorectal surgery. METHODS: A prospective and randomized clinical study was conducted in 20 patients operated of colorectal cancer during COVID-19 lockdown (13 March to 21 June 2020) in a single university clinical hospital. Patients were randomized into two study groups (10 per group): prehabilitation vs standard care. Changes in lean mass and fat mass at 45 and 90 days after surgery were measured using multifrequency bioelectrical impedance analysis. RESULTS: Prehabilitation managed to reduce hospital stay (4.8 vs 7.2 days, p = 0.052) and postoperative complications (20% vs 50%, p = 0.16). Forty-five days after surgery, the loss of lean mass decreased (1.7% vs 7.1%, p = 0.17). These differences in lean mass were attenuated at 90 days; however, the standard care group increased considerably their fat mass compared to the prehabilitation group (+ 8.72% vs - 8.16%). CONCLUSIONS: Home prehabilitation has proven its effectiveness, achieving an attenuation of lean mass loss in the early postoperative period and a lower gain in fat mass in the late postoperative period. In addition, it has managed to reduce hospital stays and postoperative complications. REGISTRATION NUMBER: This article is part of an ongoing, randomized, and controlled clinical trial approved by the ethics committee of our hospital and registered in ClinicalTrials.gov in August 2018 with registration number NCT03618329.

Photodynamic Therapy for the Treatment of Complex Anal Fistula.

BACKGROUND AND OBJECTIVES: To validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula. STUDY DESIGN/MATERIALS AND METHODS: This prospective multicentric observational study enrolled patients treated for complex anal fistula who underwent intralesional photodynamic therapy (i-PDT). The included patients were treated from January 2016 to December 2018 with a minimum follow-up of 1 year to evaluate recurrence, continence and postoperative morbidity. Intralesional 5-aminolevulinic acid (ALA) gel (2%) was injected directly into the fistula. The internal and external orifices were closed. After an incubation period of 2 hours, the fistula was irradiated using an optical fiber connected to a red laser (Multidiode 630 PDT) operating at 1 W/cm for 3 minutes (180 J). RESULTS: In total, 49 patients were included (61.2% male). The mean age was 48 years, and the mean duration of fistula was 13 months. Of the fistulas included, 75.5% were medium transphincteric, and 24.5% were high transphincteric. The median fistula length was 4 ± 1,14 cm (range: 3-5). A total of 41 patients (83.7%) had a previous history of fistula surgery. Preoperatively, some degree of anal incontinence was found in 5 patients (10.2%). No center reported any other procedure-related complications intraoperatively. Phototoxicity was found in one patient. In the first 48 hours after the procedure, fever was reported in 2 patients (4%). At the end of follow-up, total healing was observed in 32/49 patients (65.3%). No patient reported new incontinence postoperatively. CONCLUSION: i-PDT could be considered a good choice in patients with complex anal fistulas to avoid surgery and its complications. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Clinical relevance of monitoring serum adalimumab levels in axial spondyloarthritis.

Our aim was to assess the relationship between serum adalimumab levels, anti-drug antibodies (ADA) and disease activity in patients with axial spondylarthritis (SpA). We have carried out a single-centre cross-sectional study. adalimumab and ADA levels were analysed with ELISA and correlated with SpA activity using BASDAI and ASDAS scores. Adalimumab cut-off value was calculated to discriminate inactive disease/low disease activity (BASDAI < 4; ASDAS < 2.1) from moderate/high disease activity (BASDAI ≥ 4; ASDAS ≥ 2.1), using a receiver operating characteristic (ROC) curve. Up to January 2016, 51 consecutive patients were included. The median (range) age was 46.6 (18-68) and 47.1% were women. ADA prevalence was 27.5%, with none detected in the 21.6% receiving concomitant disease-modifying antirheumatic drugs (DMARDs) (p = 0.021). Adalimumab level was normal (> 3 mg/l) in 36 patients (70.6%), all without ADA. Fifteen patients (29.4%) had subtherapeutic adalimumab levels (< 3 mg/l), with ADA in 14 (93%). Median adalimumab (mg/l) was significantly higher in patients with inactive disease/low disease activity: BASDAI < 4 vs ≥ 4: 9.5 vs 2.6 (p < 0.01); ASDAS-CRP < 2.1 vs ≥ 2.1: 9.3 vs 0.3 (p < 0.001); ASDAS-ESR < 2.1 vs ≥ 2.1: 9.9 vs 3.0 (p < 0.001), and this finding was consistent with the result of the multivariate model. Patients with inactive disease/low disease activity presented significantly lower ADA levels. The adalimumab level cut-offs and area under the curve (AUC) obtained in the ROC curves were: ASDAS-CRP (< 2.1) 4.6 mg/l (AUC 81.2%; 95% CI 67.5-94.9; p < 0.001); ASDAS-ESR (< 2.1) 7.7 mg/l (AUC 82.4%; 95% CI 69.3-95.5; p < 0.001); BASDAI (< 4) 6.4 mg/l (AUC 73.5%; 95% CI 58.6-88.3; p < 0.01). In conclusion, presence of ADA in axial SpA patients treated with adalimumab was associated with lower serum drug levels. ADA levels were lower and adalimumab levels were higher in patients with inactive disease/low disease activity based on BASDAI and ASDAS indices. Concomitant treatment with MTX reduces de likelihood of finding ADA. Serum adalimumab levels above 4.6 mg/l are recommended to avoid compromising efficacy.

Phytochemicals in date co-products and their antioxidant activity.

The date agro-industry needs to find appropriate techniques to give value to their co-products. This study analyzes twelve intermediate food products (IFPs) from date co-products, Medjool and Confitera cv. at several ripening stages, blanched and unblanched, for their content in bioactive compounds (phenols, tannins, flavonoids, carotenoids and anthocyanins) and the antioxidant activity (AA). IFPs from the more unripe stages had the highest AA and phytochemicals content, mainly phenols, up to 1.4 g GAE/100 g, with high proportions of tannins. Flavonoids were found in high amounts, up to 874 mg RE/100 g. Among the AA are significant the antiradical efficiency (4.62 mM TE/100 g) and chelating activity (252 µM EDTA/100 g). Blanching was beneficial for Confitera IFPs. A positive correlation was found between phenols, tannins and flavonoids and the AA; and their content could be used as indicator of the AA. Date IFPs have potential use as an antioxidant functional ingredient.

[Duration of treatment with etanercept and motives for discontinuation in a cohort of patients with rheumatic disease]. / Duración del tratamiento con etanercept y razones de discontinuación en una cohorte de pacientes con patología reumática.

OBJECTIVE: To evaluate the duration of etanercept (ETN) treatment and motives for discontinuation in our local cohort of patients with rheumatic pathology and compare them to the group with other biological treatments. PATIENTS AND METHODS: Prospective observational cohort study. Disease diagnosis, start and end date and motive for discontinuation were recorded. Survival estimation was explored using Kaplan-Meier analysis with remaining patients censored at 1-year, 2-years and 5-years follow-up. RESULTS: Ninety-two (45%) out of 205 patients started ETN treatment. Disease diagnoses recorded were: 48% rheumatoid arthritis, 33% ankylosing spondylitis, 11% psoriatic arthritis, 8% others (juvenile idiopathic arthritis, inflammatory bowel disease related spondylitis, SAPHO syndrome). 52% of patients are still on the drug. The motives for discontinuation were: inefficacy (65%), adverse events (33%) and lack of compliance (2%). Two patients discontinued ETN due to prolonged disease control. Adverse events were: infection (4 patients), post-injection skin reaction (3), uveitis (3), neoplasia (2) and others (3). Using a Kaplan-Meier analysis, at 1-year 64% (CI(95%) 54-74) of patients with ETN treatment had not experienced treatment failure, at 2-years, 59% (48-69) and at 5-years, 43% (30-52). With the rest of biologicals estimated survival was 61% (51-68), 47,5% (40-55) and 23% (10,5-32) respectively. Statistical analysis revealed significant differences (log-rank: P=.024; Breslow: P=.068; Tarone-Ware: P=.040). CONCLUSIONS: In our cohort of patients treated with ETN the estimated survival was better than patients treated with other biological drugs at 1-year, 2-years and 5-years.