A Prospective, Single-Arm Study to Evaluate the Safety and Efficacy of an Autologous Blood Clot Product in the Treatment of Anal Fistula.

BACKGROUND: Surgical treatment of complex perianal fistula is technically challenging, associated with risk of failure, and may require multiple procedures. In recent years, several biologic agents have been developed for permanently eradicating anal fistulous disease with variable success. In this study, the treatment is an autologous whole-blood product created from the patients' blood. It forms a provisional matrix that was found to be safe and effective in healing acute and chronic cutaneous wounds. OBJECTIVE: The study aimed to assess the efficacy and safety of an autologous blood clot product as a treatment for transsphincteric perianal fistulas. DESIGN: A prospective single-arm study. SETTINGS: A single tertiary medical center. PATIENTS: Patients with simple or complex transsphincteric fistulas confirmed by MRI were included in the study. Cause was either cryptoglandular or Crohn's disease related (in the absence of active luminal bowel disease). INTERVENTION: The outpatient procedure was performed under general anesthesia and consisted of: 1) physical debridement and cleansing of the fistula tract; 2) suture closure of the internal opening; and 3) instillation of the autologous blood clot product into the entire tract. MAIN OUTCOME MEASURES: Safety and efficacy at 6- and 12-months after surgery. RESULTS: Fifty-three patients (77% men) with a median age of 42 (20-72) years were included in the study. Three patients withdrew consent, and 1 patient was lost to follow-up. At the time of this interim analysis, 49 and 33 patients completed the 6- and 12-month follow-up period. Thirty-four of the 49 patients achieved complete healing (69%) at 6 months, but 20 of the 33 patients (60%) achieved healing after 1 year. All patients who achieved healing at 6 months remained healed at the 1-year mark. In a subgroup analysis of patients with Crohn's disease, 7 of 9 patients completed 1-year follow-up, with 5 patients (71%) achieving clinical remission. No major side effects or postoperative complications were noted, but 2 adverse events occurred (admission for pain control and coronavirus 2019 infection). LIMITATIONS: Noncomparative single-arm pilot study. CONCLUSIONS: Treatment with an autologous blood clot product in perianal fistular disease was found to be feasible and safe, with an acceptable healing rate in both cryptoglandular and Crohn's disease fistula-in-ano. Further comparative assessment is required to determine its potential role in the treatment paradigm of fistula-in-ano. See Video Abstract . BRAZO PARA EVALUAR LA SEGURIDAD Y EFICACIA DE RDVER, UN COGULO DE SANGRE AUTLOGO, EN EL TRATAMIENTO DE LA FSTULA ANAL: ANTECEDENTES:El tratamiento quirúrgico de la fístula perianal compleja es técnicamente desafiante, se asocia con riesgo de fracaso y puede requerir múltiples procedimientos. En los últimos años, se han desarrollado varios agentes biológicos con el fin de erradicar permanentemente la enfermedad fistulosa anal con éxito variable. El tratamiento RD2-Ver.02 es un producto de sangre total autólogo creado a partir de la sangre de los pacientes, que forma una matriz provisional que resultó segura y eficaz para curar heridas cutáneas agudas y crónicas.OBJETIVO:Evaluar la eficacia y seguridad de RD2-Ver.02 como tratamiento para las fístulas perianales transesfinterianas.DISEÑO:Un estudio prospectivo de un solo brazo.LUGARES:Un único centro médico terciario.PACIENTES:Se incluyeron en el estudio pacientes con fístulas transesfinterianas simples o complejas confirmadas mediante resonancia magnética. La etiología fue criptoglandular o relacionada con la enfermedad de Crohn (en ausencia de enfermedad intestinal luminal activa).INTERVENCIÓN:El procedimiento ambulatorio se realizó bajo anestesia general y consistió en: 1) desbridamiento físico y limpieza del trayecto fistuloso; 2) cierre con sutura de la abertura interna; y 3) instilación de RD2-Ver.02 en todo el tracto.PRINCIPALES MEDIDAS DE VALORACIÓN:Seguridad y eficacia a los 6 y 12 meses después de la cirugía.RESULTADOS:Se incluyeron en el estudio 53 pacientes (77% varones) con una mediana de edad de 42 (20-72) años. Tres pacientes retiraron su consentimiento y un paciente se perdió durante el seguimiento. En el momento de este análisis intermedio, 49 y 33 pacientes completaron el período de seguimiento de 6 y 12 meses, respectivamente. Treinta y cuatro (34) pacientes lograron una curación completa (69%) a los 6 meses, mientras que 20 de 33 pacientes (60%) lograron una curación después de un año. Todos los pacientes que lograron la curación a los 6 meses permanecieron curados al año. En un análisis de subgrupos de pacientes con enfermedad de Crohn, 7/9 pacientes completaron un seguimiento de un año y 5 pacientes (71%) alcanzaron la remisión clínica. No se observaron efectos secundarios importantes ni complicaciones postoperatorias, mientras que ocurrieron 2 eventos adversos (ingreso para control del dolor e infección por COVID-19).LIMITACIONES:Estudio piloto no comparativo de un solo brazo.CONCLUSIONES:Se encontró que el tratamiento con RD2-Ver.02 en la enfermedad fístula perianal es factible y seguro, con una tasa de curación aceptable tanto en la fístula criptoglandular como en la de Crohn en el ano. Se requiere una evaluación comparativa adicional para determinar su papel potencial en el paradigma de tratamiento de la fístula anal. (Pre-proofed version ).

The predicting value of post neoadjuvant treatment magnetic resonance imaging: a meta-analysis.

INTRODUCTION: Neoadjuvant therapy has become standard of care for locally advanced rectal cancer patients. It is correlated with improved clinical and pathological outcomes, including significant tumor downstaging and organ preservation in certain patients. Magnetic resonance imaging (MRI), which has become the standard for pre-operative staging, is also used for clinical and pre-operative restaging following pre-operative treatment. In this meta-analysis, we aimed to evaluate the concordance between restaging MRI (following the completion of neoadjuvant therapy) and postoperative pathology result. METHODS: We conducted a meta-analysis following the PRISMA 2020 guidelines. Two independent reviewers searched PubMed and Google Scholar for studies reporting restaging MRI results compared to pathological outcomes. Outcomes included tumor and nodal staging, circumferential resection margin (CRM) and pathological complete response (pCR). RESULTS: Out of 25,000 studies found on the initial search; 33 studies were included. The studies were published between 2005 and 2023 and included 4100 patients (57.14% males). The median age was 62.45 years. The median interval between the conclusion of neoadjuvant treatment and the subsequent restaging MRI was 6 weeks (range 4.14-8.8 weeks). The pooled concordance rates between the restaging MRI and the pathological outcomes for ypT stage and ypN stage were 63.9% (54.5%-73.3%, I2 = 96.02%) and 60.9% (42.9%-78.9%, I2 = 98.96%), respectively. The pooled concordance for predicting pathological complete response was 70.4% (53.6%-87.1%, I2 = 98.21%). As for the circumferential resection margin (CRM), the pooled concordance was 78.2.% (71.6%-84.8%, I2 = 83.76%). CONCLUSIONS: Our findings suggest that the concordance rates between restaging MRI and pathological outcomes in rectal cancer patients following neoadjuvant therapy are limited. Caregivers should take these results into consideration when making clinical decisions about these patients. More data should be gathered about the predictive value of MRI after total neoadjuvant therapy as well as immunotherapy in rectal cancer patients.

[SURGICAL TREATMENT USING ROBOTIC APPROACH FOR OBSTRUCTED DEFECATION SYNDROME (ODS)].

INTRODUCTION: Obstructed Defecation Syndrome (ODS) is a complex surgical condition which involves structural and functional problems which significantly affects quality of life. There is limited information about the Da-Vinci Robotic System use in the treatment of this condition. This study examines the outcomes of robotic-assisted rectopexy. The primary outcome is recovery from surgery, with secondary outcomes including post-surgical complications, length of hospital stay, rehospitalization rate and recurrence after surgery. METHODS: A retrospective analysis was conducted of prospectively collected data for patients who underwent robotic assisted surgery for ODS between 2011-2022. A colorectal surgeon performed all surgeries at the Sheba Medical Center using the Da Vinci™ robotic system. This analysis uses descriptive statistics and presents the results as medians and ranges. RESULTS: Out of 33 patients included, 26 (84.9%) were female. Median age was 67 years (Range:19-85 years). Median American Society of Anesthesiology (ASA) score was 2 (1-3). Median Charlson's comorbidity score was 3 (0-4). Median patients' Body Mass Index (BMI) was 23.2 (15.6-33.4) kg/m2. Eight patients (24.4%) underwent previous procedure for ODS. Most (23) patients included (69.7%) underwent robotic assisted ventral rectopexy. Other interventions included combined anterior and posterior rectopexy (9.1%), combined ventral rectopexy and sacrocolpopexy (12.1%) and posterior rectopexy (9.1%). No cases of conversion to laparoscopic /open techniques were recorded. Median operation time was 135 minutes (70-270). One intra-operative complication recorded was an injury to the rectum during anterior dissection (3%). No significant blood loss was recorded. A total of 27 patients (81.8%) were operated using the Da Vinci Si system, and the rest (6) using the 6 Da Vinci Xi system. Two patients had post-operative complications. Median length of stay (LOS) was 4 days (2-6 days). Readmission rate within 30 days was 9.1%. Two patients (6.1%) had recurrence of rectal prolapse. Median follow-up was 60 (4-116) months. CONCLUSIONS: Robotic-assisted surgery for obstructed defecation syndrome is safe, with fast recovery of the patient and it is efficient during long-term follow-up.