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 ).

Ultrasound-Tomographic Image Fusion - A Novel Tool for Follow up After Acute Complicated Appendicitis.

BACKGROUND: Computerized tomography (CT) is an integral part of the follow-up and decision-making process in complicated acute appendicitis (AA) treated non-operatively. However, repeated CT scans are costly and cause radiation exposure. Ultrasound-tomographic image fusion is a novel tool that integrates CT images to an Ultrasound (US) machine, thus allowing accurate assessment of the healing process compared to CT on presentation. In this study, we aimed to assess the feasibility of US-CT fusion as part of the management of appendicitis. MATERIALS AND METHODS: We retrospectively collected data of consecutive patients with complicated AA managed non-operatively and followed up with US Fusion for clinical decision-making. Patients demographics, clinical data, and follow-up outcomes were extracted and analyzed. RESULTS: Overall, 19 patients were included. An index Fusion US was conducted in 13 patients (68.4%) during admission, while the rest were performed as part of an ambulatory follow-up. Nine patients (47.3%) had more than 1 US Fusion performed as part of their follow-up, and 3 patients underwent a third US Fusion. Eventually, 5 patients (26.3%) underwent elective interval appendectomy based on the outcomes of the US Fusion, due to a non-resolution of imaging findings and ongoing symptoms. In 10 patients (52.6%), there was no evidence of an abscess in the repeated US Fusion, while in 3 patients (15.8%), it significantly diminished to less than 1 cm in diameter. CONCLUSION: Ultrasound-tomographic image fusion is feasible and can play a significant role in the decision-making process for the management of complicated AA.

Three-dimensional reconstruction of computed tomography colonography discloses anatomic features associated with colonoscopy failure.

Objectives: Three-dimensional virtual reality (3D VR) permits precise reconstruction of computed tomography (CT) images, and these allow precise measurements of colonic anatomical parameters. Colonoscopy proves challenging in a subset of patients, and thus CT colonoscopy (CTC) is often required to visualize the entire colon. The aim of the study was to determine whether 3D reconstructions of the colon could help identify and quantify the key anatomical features leading to colonoscopy failure. Design: Retrospective observational study. Methods: Using 3D VR technology, we reconstructed and compared the length of various colonic segments and number of bends and colonic width in 10 cases of CTC in technically failed prior colonoscopies to 10 cases of CTC performed for non-technically failure indications. Results: We found significant elongation of the sigmoid colon (71 ± 23 cm versus 35 ± 9; p = 0.01) and of pancolonic length (216 ± 38 cm versus 158 ± 20 cm; p = 0.001) in cases of technically failed colonoscopy. There was also a significant increase in the number of colonic angles (17.7 ± 3.2 versus 12.7 ± 2.4; p = 0.008) in failed colonoscopy cases. Conclusion: Increased sigmoid and pancolonic length and more colonic bends are novel factors associated with technical failure of colonoscopy.

Using Virtual Reality for Deep Inferior Epigastric Perforator Flap Preoperative Planning.

This study was designed to compare VR stereoscopical three-dimensional (3D) imaging with two-dimensional computed tomography angiography (CTA) images for evaluating the abdominal vascular anatomy before autologous breast reconstruction. Methods: This prospective case series feasibility study was conducted in two tertiary medical centers. Participants were women slated to undergo free transverse rectus abdominis muscle, unilateral or bilateral deep inferior epigastric perforator flap immediate breast reconstruction. Based on a routine CTA, a 3D VR model was generated. Before each procedure, the surgeons examined the CTA and then the VR model. Any new information provided by the VR imaging was submitted to a radiologist for confirmation before surgery. Following each procedure, the surgeons completed a questionnaire comparing the two methods. Results: Thirty women between 34 and 68 years of age were included in the study; except for one, all breast reconstructions were successful. The surgeons ranked VR higher than CTA in terms of better anatomical understanding and operative anatomical findings. In 72.4% of cases, VR models were rated having maximum similarity to reality, with no significant difference between the type of perforator anatomical course or complexity. In more than 70% of the cases, VR was considered to have contributed to determining the surgical approach. In four cases, VR imaging modified the surgical strategy, without any complications. Conclusions: VR imaging was well-accepted by the surgeons who commented on its importance and ease compared with the standard CTA presentation. Further studies are needed to determine whether VR should become an integral part of preoperative deep inferior epigastric perforator surgery planning.

Ultrasound-Tomographic Image Fusion: A Novel Imaging Technique for Follow-Up of Penetrating Complications of Crohn's Disease.

We herein report the first use, to our knowledge, of computed tomography-ultrasound (US) fusion technique to follow-up Crohn's disease complications. This novel technique employs real-time reconstructed fusion of previously obtained tomographic images onto the US image software, allowing accurate bedside spatial resolution, localization, and lesion characterization by US.

Using Augmented Reality for Intraoperative Guidance During Sacral Neuromodulation System Implantation.

Objective: The purpose of this study was to examine the feasibility of using augmented reality during lead placement for sacral nerve stimulation (SNS). Methods: The study was a prospective case series performed in a single tertiary center. Patients with fecal incontinence or urinary retention eligible for SNS according to the American society of colon and rectal surgeon's guidelines were included. Each patient underwent a computerized tomography scan of the sacrum and pelvic floor before surgery; and a segmentation of the sacral bone, the skin, and three fiducial markers on the lower back was produced. Surgical planning included the design of an ideal virtual transmission tract leading to the S3 foramen using the most suitable location and needle trajectory for introducing the lead. During the surgical intervention, a needle was inserted into the S3 foramen using the aligned tract as visualized using the Microsoft HoloLens first generation head mounted unit. Results: Overall, 11 patients were included. Mean operative time was 43.8 minutes (range 25-81 minutes). All patients reported a significant reduction from the preoperative level of the mean postoperative Cleveland Clinic Incontinence Score (CCIS) assessed 2 weeks after the temporary SNS implant (CCIS preoperative 13.3, postoperative 8.5; CI -7.35 to -2.25; P < 0.01). The surgeons reported the imaging useful, allowing accurate and easier approach. Conclusions: Intraoperative augmented reality imaging for needle application during SNS appears to be feasible, practical, and may be useful in additional procedures.