Ensayo clínico fase III, unicéntrico, aleatorizado, doble ciego en dos grupos paralelos para comparar la eficacia y seguridad del plasma rico en factores de crecimiento (prgf) frente al adhesivo de fibrina (tissucolr) para el sellado de las fístulas anales de origen criptoglandular tras un periodo de 48 semanas

La enfermedad fistulosa perianal criptoglandular es una de las enfermedades anorrectales mas frecuentes y aunque existen pocos datos a cerca de su prevalencia, se estima que hasta un 10 al 30% de las intervenciones coloproctologicas son por fistula perianal. Aunque un porcentaje importante de fistulas son fistulas simples y pueden ser resueltas de forma sencilla mediante fistulotomia o fistulectomia, un menor porcentaje de las mismas son fistulas complejas, cuyo tratamiento supone hoy dia un importante reto para el cirujano ya que debe lograr la curacion de la misma sin producir un dano en el aparato esfinteriano que pueda repercutir en altercaciones de la continencia. En los ultimos 25 anos se han propuesto numerosos tratamientos con el fin de mejorar los resultados en cuanto a curacion disminuyendo al maximo los cambios en la continencia postoperatoria. Sin embargo, a dia de hoy, ninguna de las tecnicas empleadas ha demostrado altas tasas de curacion sin alterar la continencia. En un intento de buscar una alternativa terapeutica factible, reproducible, segura y eficaz, se han publicado varios estudios que situan a los factores de crecimiento como una alternativa util para el tratamiento de la fistula perianal de origen criptoglandular. En base a todo lo expuesto anteriormente, se proponen las siguientes hipotesis: H0: El uso del PRGF como agente sellante para el tratamiento de la fistula anal de origen criptoglandular NO mejora los resultados obtenidos en terminos de eficacia frente al uso de fibrina. H1: El uso de PRGF como agente sellante para el tratamiento de la fistula anal de origen criptogladular mejora los resultados obtenidos en terminos de eficacia frente al uso de fibrina. Evaluar la eficacia del PRGF como agente sellante para el tratamiento de la fistula anal compleja de origen criptoglandular comparado con el sellante de fibrina, mediante la proporcion de pacientes respondedores al cabo de los 12 meses de finalizado el tratamiento. Un respondedor (curación completa), se define como aquel que al cabo de un ano posterior al sellado, no presenta supuracion ni manchado por el OFE y este se encuentra totalmente reepitelizado. Un respondedor parcial (curación parcial), se define como aquel que al cabo de un ano posterior al sellado, no presenta supuracion ni manchado por el OFE, pero este no se encuentra totalmente reepitelizado. Definimos como curación global, la suma de la curacion completa y la curacion parcia

Personalized additive manufacturing of devices for the management of enteroatmospheric fistulas

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.Additive manufacturing techniques allow the customized design of medical devices according to the patient's requirements. Enteroatmospheric fistula is a pathology that benefits from this personalization due to its extensive clinical variability since the size and morphology of the wound differ extensively among patients. Standard prosthetics do not achieve proper isolation of the wound, leading to a higher risk of infections. Currently, no effective personalized technique to isolate it has been described. In this work, we present the workflow for the design and manufacture of customized devices adapted to the fistula characteristics as it evolves and changes during the treatment with Negative Pressure Wound Therapy (NPWT). For each case, a device was designed with dimensions and morphology depending on each patient's requirements using white light scanning, CAD design, and additive manufacturing. The design and manufacture of the devices were performed in 230.50 min (184.00– 304.75). After the placement of the device, the wound was successfully isolated from the intestinal content for 48–72 h. The therapy was applied for 27.71 ± 13.74 days, and the device was redesigned to adapt to the wound when geometrical evolutionary changes occur during the therapy. It was observed a decrease in weekly cures from 23.63 ± 10.54 to 2.69 ± 0.65 (p = 0.001). The fistulose size was reduced longitudinal and transversally by 3.25 ± 2.56 cm and 6.06 ± 3.14 cm, respectively. The wound depth also decreased by 1.94 ± 1.08 cm. In conclusion, customization through additive manufacturing is feasible and offers promising results in the generation of personalized devices for the treatment of enteroatmospheric fistula.Instituto de Salud Carlos III PI19/0182

Platelet-rich plasma (PRP) versus fibrin glue in cryptogenic fistula-in-ano: a phase III single-center, randomized, double-blind trial

[Purpose] To compare the clinical outcome of autologous platelet-rich growth factor (PRP) with commercial fibrin glue in the management of high cryptogenic fistulae-in-ano.[Method] The study was conducted at a single center between July 2012 and July 2015 and performed as a phase III, randomized, double-blind comparison of autologously prepared PRP versus fibrin glue for cryptoglandular anal fistulae without active sepsis. Patients were assessed with clinical and endosonographic follow-up. Patients were followed up at 1 week and then at 3, 6, and 12 postoperative months. The primary outcome measure was the fistula healing rate (complete, partial, and non-healing) with secondary outcome measures assessing fistula recurrence, continence status, quality of life, and visual analog pain scores.[Results] Of the 56 enrolled patients, 32 were PRP-treated and 24 were fibrin-treated. The groups were well matched for fistula type with an improved overall healing rate for PRP-treated over fibrin-treated cases (71% vs. 58.3%, respectively; P = 0.608); a complete healing rate of 48.4% vs. 41.7%, respectively; and a partial healing rate of 22.6% vs. 16.7%, respectively. The median pain scores of PRP-treated patients were lower at the first visit with a greater initial pain decrease early during follow-up. Improvements in pain reduction impacted the quality of life measures (P = 0.035). All adverse events were minor and no patient experienced a negative impact on continence.[Conclusion] Treatment of complex cryptoglandular anal fistula with autologous PRP is as effective as fibrin glue with less cost and no adverse effect on continence.A Grant for this work was provided by the Fundación Española de Coloproctología.Peer reviewe

Laparoscopic peritoneal lavage versus laparoscopic sigmoidectomy in complicated acute diverticulitis: a multicenter prospective observational study

11sinonePurpose: Laparoscopic peritoneal lavage (LPL) is feasible in selected patients with pelvic abscess and generalized purulent peritonitis caused by acute diverticulitis. We aimed to compare LPL and laparoscopic sigmoidectomy (LS) in complicated acute diverticulitis. Methods: This prospective, observational, multicenter study included patients with a pelvic abscess not amenable to conservative management and patients with Hinchey III acute diverticulitis, from 2015 to 2018. Sixty-six patients were enrolled: 28 (42%) underwent LPL and 38 (58%) underwent LS. In LS, patients had a primary anastomosis, with or without ileostomy, or an end colostomy (HA). Major outcomes were mortality, morbidity, failure of source control, reoperation, length of stay, and diverticulitis recurrence. Results: Patient demographics were similar in the two groups. In LPL, ASA score > 2 and Mannheim Peritonitis Index were significantly higher (p = 0.05 and 0.004). In LS, 24 patients (63%) had a PA and 14 (37%) an HA. No death was recorded. Overall, morbidity was 33% in LPL and 18% in LS (p = 0.169). However, failure to achieve source control of the peritoneal infection and the need to return to the operating room were more frequent in LPL (p = 0.002 and p = 0.006). Mean postoperative length of stay was comparable (p = 0.08). Diverticular recurrence was significantly higher in LPL (p = 0.003). Conclusion: LPL is related to a higher reoperation rate, more frequent postoperative ongoing sepsis, and higher recurrence rates. Therefore, laparoscopic lavage for perforated diverticulitis carries a high risk of failure in daily practice.noneTartaglia D.; Di Saverio S.; Stupalkowska W.; Giannessi S.; Robustelli V.; Coccolini F.; Ioannidis O.; Nita G.E.; Munoz-Cruzado V.M.D.; Ciuro F.P.; Chiarugi M.Tartaglia, D.; Di Saverio, S.; Stupalkowska, W.; Giannessi, S.; Robustelli, V.; Coccolini, F.; Ioannidis, O.; Nita, G. E.; Munoz-Cruzado, V. M. D.; Ciuro, F. P.; Chiarugi, M

Management of acute mesenteric ischaemia: Results of a worldwide survey

© 2023 The AuthorsBackground: Acute mesenteric ischaemia (AMI) is a condition with high mortality. This survey assesses current attitudes and practices to manage AMI worldwide. Methods: A questionnaire survey about the practices of diagnosing and managing AMI, endorsed by several specialist societies, was sent to different medical specialists and hospitals worldwide. Data from individual health care professionals and from medical teams were collected. Results: We collected 493 individual forms from 71 countries and 94 team forms from 34 countries. Almost half of respondents were surgeons, and most of the responding teams (70%) were led by surgeons. Most of the respondents indicated that diagnosis of AMI is often delayed but rarely missed. Emergency revascularisation is often considered for patients with AMI but rarely in cases of transmural ischaemia (intestinal infarction). Responses from team hospitals with a dedicated special unit (14 team forms) indicated more aggressive revascularisation. Abdominopelvic CT-scan with intravenous contrast was suggested as the most useful diagnostic test, indicated by approximately 90% of respondents. Medical history and risk factors were thought to be more important in diagnosis of AMI without transmural ischaemia, whereas for intestinal infarction, plasma lactate concentrations and surgical exploration were considered more useful. In elderly patients, a palliative approach is often chosen over extensive bowel resection. There was a large variability in anticoagulant treatment, as well as in timing of surgery to restore bowel continuity. Conclusions: Delayed diagnosis of AMI is common despite wide availability of an adequate imaging modality, i.e. CT-scan. Large variability in treatment approaches exists, indicating the need for updated guidelines. Increased awareness and knowledge of AMI may improve current practice until more robust evidence becomes available. Adherence to the existing guidelines may help in improving differences in treatment and outcomes