Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study).

BACKGROUND: Perianal fistulas may affect 15-50% of patients with Crohn's disease. Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogenic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European and Spanish Agencies of Medicines and Medical Products as a treatment for fistulas in Crohn's disease. Recent European Crohn's and Colitis Organisation and Spanish Working Group on Crohn's Disease and Ulcerative Colitis guidelines state that darvadstrocel is effective with a favorable safety profile and a strong level of evidence (2). OBJECTIVE: Presenting real-world effectiveness data for darvadstrocel in a Spanish population. DESIGN: Observational retrospective cohort study with prospective data gathering. SETTINGS: Fourteen institutions. PATIENTS: From November 2019-April 2022, all patients (73) treated with darvadstrocel in these institutions were included, fulfilling the following criteria: 1) complex fistula/s in a patient with Crohn's disease; 2) failure of conventional and antitumor necrosis factor treatment; 3) absence of collections >2 cm confirmed by pelvic MRI scan at the time of surgery. INTERVENTIONS: Darvadstrocel treatment. MAIN OUTCOME MEASURES: Clinical response (closure of ≥50% of external openings), complete clinical closure (100% of external openings) and radiological closure (no fluid collection >2 cm, no edema or inflammation) evaluated 6 months after treatment. RESULTS: Clinical response was observed in 63 patients (86.3%), complete clinical closure in 50 patients (68.5%) and radiological closure in 45 patients (69.2%). Combined clinical and radiological response was observed in 41 patients (63.1%). Not all clinically healed patients had radiological closure and vice versa. No serious adverse events were reported. LIMITATIONS: Retrospective. CONCLUSIONS: Study results were consistent with those reported in previous clinical trials, real-world efficacy findings from the INSPIRE study (assessing darvadstrocel effectiveness in Europe, Israel, Switzerland, UK, and Japan) and previously published literature. Darvadstrocel was effective and demonstrated a favorable safety profile when used in normal clinical practice for treatment of fistulas in Crohn's disease. See Video Abstract.

Patient engagement and satisfaction with early phase cell therapy clinical trials at a tertiary inflammatory bowel disease center.

Several clinical trials are underway investigating cell and gene therapy, and while these trials are meant to significantly impact patient care, they rely on patient engagement and participation. Unfortunately, clinical trials generally require extensive commitment by subjects. While several studies are using validated surveys to measure patient-reported outcomes, there is a lack of characterization of the patient experience as a subject in these trials. As such, we surveyed mesenchymal stromal cell (MSC) trial participants to understand their perspective. We found that there exists a reliance on one's gastroenterologist and colorectal surgeons for trial introduction and that time and cost were the main barriers to participation. Overall, participants demonstrated high satisfaction with MSC trial participation, but future protocols could incorporate increased use of virtual appointments to optimize patient experience.

Salvage Surgery: An Effective Therapy in the Management of Ileoanal Pouch Prolapse.

BACKGROUND: Restorative proctocolectomy with IPAA is the surgical treatment of choice for patients requiring surgery for IBD and, less frequently, for other pathologies. Pouch prolapse is a rare complication that compromises pouch function and negatively affects patients' quality of life. OBJECTIVE: This study aimed to describe our experience from a single high-volume center in this infrequent condition. DESIGN: Restrospective cohort study of a prospectively maintained, Institutional Review Board-approved database. SETTINGS: All consecutive eligible patients with IPAA and pouch prolapse were identified from 1990 to 2021. PATIENTS: Patients with full-thickness prolapse treated by pouch pexy were included. INTERVENTIONS: Pouch pexy (with/without mesh). MAIN OUTCOME MEASURES: Success rate of pouch pexy, defined as no recurrence of prolapse. RESULTS: A total of 4791 patients underwent IPAA; 7 (0.1%) were diagnosed with full-thickness prolapse. An additional 18 patients who underwent IPAA and had full-thickness prolapse were referred from outside institutions. Among 25 included patients, 16 (64.0%) were women, and the overall mean age was 35.6 ± 13.4 years. The time interval from initial pouch formation to prolapse was 4.2 (interquartile range, 1.1-8.5) years. Nine patients (36.0%) underwent previous treatment for prolapse. All patients presented with symptoms and physical examination compatible with full-thickness prolapse. Twenty patients (80.0%) underwent surgical pouch pexy without mesh and 5 (20.0%) had pouch pexy with mesh placement. A diverting ileostomy was performed in 1 patient (4.0%) before pouch pexy and in 8 patients (32.0%) at the time of surgical prolapse correction. After surgery, recurrent prolapse was noted in 3 patients (12.0%) at a median of 6.9 (interquartile range, 5.2-8.3) months. LIMITATIONS: Retrospective study, small sample size thus prone to selection, and referral biases, which may limit the generalizability of our findings. CONCLUSION: Pouch prolapse can be effectively treated with salvage surgery. Surgical intervention is safe and provides acceptable outcomes. See Video Abstract. CIRUGA DE RESCATE UNA TERAPIA EFICAZ EN EL MANEJO DEL PROLAPSO DE LA BOLSA ILEOANAL: ANTECEDENTES:La proctocolectomía restauradora con anastomosis reservorio ileoanal es el tratamiento quirúrgico de elección para aquellos pacientes que requieren cirugía por enfermedad inflamatoria intestinal y, con menor frecuencia, por otras patologías. El prolapso de la bolsa es una complicación rara que compromete la función de la bolsa y afecta de manera negativa la calidad de vida de los pacientes.OBJETIVO:Describir nuestra experiencia de un solo centro de alto volumen en esta condición poco frecuente.DISEÑO:Estudio de cohorte retrospectivo de una base de datos mantenida prospectivamente aprobada por el IRB.AJUSTES/PACIENTES:Fueron identificados y elegibles de manera consecutiva todos los pacientes con anastomosis de bolsa ileoanal y prolapso de bolsa entre 1990 y 2021. Se incluyeron pacientes con prolapso de bolsa de espesor total tratados con pexia.INTERVENCIONES:Pexia de la bolsa (con/sin malla).PRINCIPALES MEDIDAS DE RESULTADO:Tasa de éxito de la pexia de la bolsa, definida como ausencia de recurrencia del prolapso.RESULTADOS:Un total de 4.791 pacientes fueron sometidos a anastomosis de bolsa ileoanal; siete (0,1%) fueron diagnosticados con prolapso de espesor total. Otros 18 pacientes con anastomosis de reservorio ileoanal fueron derivados de instituciones externas. De entre los 25 pacientes incluidos, 16 (64,0 %) eran mujeres y la edad media promedio fue de 35,6+/-13,4 años. El intervalo de tiempo desde la creación inicial de la bolsa hasta el prolapso fue de 4,2 (IQR 1,1-8,5) años. Nueve (36,0 %) pacientes fueron sometidos a tratamiento previo para el prolapso (fisioterapia n = 4, pexia de la bolsa n = 2, pexia de la bolsa con malla n = 2, resección de la mucosa n = 1). Todos los pacientes presentaron síntomas y exploración física compatibles con prolapso de espesor total. Veinte (80,0%) pacientes se sometieron a pexia de bolsa quirúrgica sin malla y cinco (20,0%) se sometieron a pexia de bolsa con colocación de malla. Se realizó una ileostomía de derivación en un (4,0%) paciente antes de la pexia de la bolsa y en ocho (32,0%) pacientes en el momento de la corrección quirúrgica del prolapso. Posterior a la cirugía, se observó prolapso recurrente en tres pacientes (12,0 %) con una mediana de 6,9 (IQR 5,2-8,3) meses.LIMITACIONES:Estudio retrospectivo, pequeño tamaño de muestra, por lo tanto, propenso a sesgos de selección y referencia que pueden limitar la generalización de nuestros hallazgos.CONCLUSIÓN:El prolapso de la bolsa ileoanal puede tratarse de manera efectiva mediante la cirugía de rescate. La intervención quirúrgica es segura y proporciona resultados aceptables. (Traducción-Dr. Mauricio Santamaria ).

Surgical Options for the Treatment of Perianal and Anovaginal Fistulas in the Setting of Ileoanal Pouch Crohn's Disease: Experience of a Tertiary Center.

BACKGROUND: The leading cause of pouch failure following ileal pouch-anal anastomosis are peri-pouch fistulas and pelvic sepsis. OBJECTIVE: Determine the overall efficacy of current surgical therapy for the treatment of perianal and anovaginal fistulizing disease related to Crohn's disease phenotype of the pouch. DESIGN: Retrospective cohort study of a prospectively maintained, IRB-approved database. SETTINGS/PATIENTS: Ninety-one (2.3%) patients of 3058 patients with an original diagnosis of ulcerative colitis who underwent proctocolectomy with ileal pouch-anal anastomosis between 2000 and 2021 at the Cleveland Clinic and underwent postoperative surgery for Crohn's-related perianal disease. INTERVENTIONS: Two hundred thirty-one operations for perianal or anovaginal fistula(s). MAIN OUTCOME AND MEASURES: Healing rate of surgical therapy for peri-pouch fistulizing disease, impact of recurrent interventions on outcomes, and predictors of surgical failure. RESULTS: Overall mean age was 39.1 (± 11.6) years, with a BMI of 25.3 (± 6.3) kg/m2. More than half of the patients were female (n = 52, 57.1%). Sixty-three patients (69.2%) had a perianal fistula, 25 (27.5%) had an anovaginal fistula, and 3 (3.3%) patients had both. Overall success rate for healing was 59.3% (n = 54/91) at a mean follow-up of 6.4 (± 4.8) years. Seventeen (18.7%) patients underwent a concomitant diverting loop ileostomy. Among them, eight (47.0%) patients had the ileostomy closure after a mean time of 9.7 (± 2.8) months. In the multivariable logistic regression model, patients who had seton insertions in any operation were significantly less likely to heal (OR 0.11 95%, CI 0.03-0.43, p = 0.001). Overall pouch failure rate was 12.1%. LIMITATIONS: Retrospective single-center study which lacks a control arm and consistent long-term follow-up specific to a population-based dataset. CONCLUSIONS: Pouch patients who develop perianal disease are difficult to treat, sometimes requiring pouch excision. However, when medical treatment alone is not effective, a multidisciplinary approach including surgical intervention can result in complete fistula healing in more than half of the cases.

Time Interval Between the End of Neoadjuvant Therapy and Elective Resection of Locally Advanced Rectal Cancer in the CRONOS Study.

Importance: The treatment for extraperitoneal locally advanced rectal cancer (LARC) is neoadjuvant therapy (NAT) followed by total mesorectal excision (TME). Robust evidence on the optimal time interval between NAT completion and surgery is lacking. Objective: To assess the association of time interval between NAT completion and TME with short- and long-term outcomes. It was hypothesized that longer intervals increase the pathologic complete response (pCR) rate without increasing perioperative morbidity. Design, Setting, and Participants: This cohort study included patients with LARC from 6 referral centers who completed NAT and underwent TME between January 2005 and December 2020. The cohort was divided into 3 groups depending on the time interval between NAT completion and surgery: short (≤8 weeks), intermediate (>8 and ≤12 weeks), and long (>12 weeks). The median follow-up duration was 33 months. Data analyses were conducted from May 1, 2021, to May 31, 2022. The inverse probability of treatment weighting method was used to homogenize the analysis groups. Exposure: Long-course chemoradiotherapy or short-course radiotherapy with delayed surgery. Main outcome and Measures: The primary outcome was pCR. Other histopathologic results, perioperative events, and survival outcomes constituted the secondary outcomes. Results: Among the 1506 patients, 908 were male (60.3%), and the median (IQR) age was 68.8 (59.4-76.5) years. The short-, intermediate-, and long-interval groups included 511 patients (33.9%), 797 patients (52.9%), and 198 patients (13.1%), respectively. The overall pCR was 17.2% (259 of 1506 patients; 95% CI, 15.4%-19.2%). When compared with the intermediate-interval group, no association was observed between time intervals and pCR in short-interval (odds ratio [OR], 0.74; 95% CI, 0.55-1.01) and long-interval (OR, 1.07; 95% CI, 0.73-1.61) groups. The long-interval group was significantly associated with lower risk of bad response (tumor regression grade [TRG] 2-3; OR, 0.47; 95% CI, 0.24-0.91), systemic recurrence (hazard ratio, 0.59; 95% CI, 0.36-0.96), higher conversion risk (OR, 3.14; 95% CI, 1.62-6.07), minor postoperative complications (OR, 1.43; 95% CI, 1.04-1.97), and incomplete mesorectum (OR, 1.89; 95% CI, 1.02-3.50) when compared with the intermediate-interval group. Conclusions and Relevance: Time intervals longer than 12 weeks were associated with improved TRG and systemic recurrence but may increase surgical complexity and minor morbidity.

A Phase I Study of Ex Vivo Expanded Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells for the Treatment of Pediatric Perianal Fistulizing Crohn's Disease.

BACKGROUND: Perianal fistulizing Crohn's disease is notoriously difficult to treat. Recent studies of mesenchymal stem cells have demonstrated safety and efficacy of this novel treatment approach. However, no studies to date have included pediatric patients. We sought to determine safety and efficacy of mesenchymal stem cells for pediatric perianal fistulizing Crohn's disease. METHODS: This was a phase I clinical trial to evaluate safety and feasibility of mesenchymal stem cells in pediatric perianal Crohn's patients 13 to 17 years of age. At the time of an exam under anesthesia, following curettage of the fistula tract and closure of the internal opening with absorbable suture, 75 million mesenchymal stem cells were administered with a 22-gauge needle. This was repeated at 3 months if complete clinical and radiographic healing were not achieved. Adverse and serious adverse events at were measured at postprocedure day 1, week 2, week 6, month 3, month 6, and month 12. Clinical healing, radiographic healing per magnetic resonance imaging, and patient-reported outcomes were measured at the same time points. RESULTS: Seven pediatric patients were enrolled and treated (6 male; median age of 16.7 years). There were no adverse or serious adverse events related to the investigational product or injection procedure. At 6 months, 83% had complete clinical and radiographic healing. The perianal Crohn's Disease Activity Index, Wexner incontinence score, and Van Assche score had all decreased at 6 months. CONCLUSIONS: Bone marrow-derived mesenchymal stem cells offer a safe, and likely effective, treatment approach for pediatric perianal fistulizing Crohn's disease.

Word of caution: Rectal cancer without response to neoadjuvant treatment - Do not wait for surgery.

BACKGROUND: We hypothesized that prolonging the interval to surgery in non-responders to neoadjuvant chemoradiation therapy (nCRT) could lead to worse oncologic outcomes. METHODS: Rectal adenocarcinoma patients with poor tumor response to nCRT (AJCC tumor regression grade 3) were selected. Oncologic outcomes were evaluated according to the time interval between completion of nCRT and surgery. RESULTS: Among 56 non-responders, 28 patients surgically treated ≥8 weeks after completion of nCRT had worse disease-free survival (31% vs. 49%, p â€‹= â€‹0.05) and worse overall survival (34% vs. 53%, p â€‹= â€‹0.02) compared to patients <8 weeks. Using the three different intervals (≥12 weeks, 6-12 weeks, and< 6 weeks), waiting longer was consistently associated with worse overall (23% vs. 48% vs. 63%, p â€‹= â€‹0.02) and worse cancer-specific survival (35% vs. 61% vs. 71%, p â€‹= â€‹0.04), respectively. CONCLUSION: For rectal cancer patients who are non-responders to nCRT, delay of surgery may lead to worse oncologic outcomes.

Salvage surgery is an effective alternative for J-pouch afferent limb stricture treatment.

BACKGROUND: Restorative proctocolectomy with ileal pouch-anal anastomosis is the surgical treatment of choice for patients requiring surgery for inflammatory bowel disease. A stricture located at the inlet of the afferent limb can lead to small bowel obstruction in a limited number of patients with a pelvic pouch. This paper aims to examine our experience with afferent limb stricture surgical correction when other endoscopic treatment methods have failed to control obstructive symptoms. METHODS: All consecutive eligible patients with ileal pouch-anal anastomosis and afferent limb stricture were identified from our institutional review board-approved database from 1990 to 2021. Patients surgically treated with excision and reimplantation/strictureplasty of afferent limb stricture were included in this study. RESULTS: Twenty patients met our inclusion criteria. Fifteen (75%) were female, and the overall mean age was 41 ± 10.3 years at afferent limb stricture surgery. The interval from ileal pouch-anal anastomosis formation to surgery for afferent limb stricture was 13.5 ± 6.7 years. Nine (45%) underwent strictureplasty, and 11 (55%) had resection and reimplantation of the afferent limb into the pouch. Before afferent limb stricture surgery, 3 (15%) required a diverting ileostomy for their obstructive symptoms. An additional 12 (60%) had a stoma constructed during afferent limb stricture surgery, and 5 had a strictureplasty and no stoma. Postoperatively, 1 patient (5%) had a leak at the afferent limb stricture repair site. All patients had their ileostomy closed 3.2 (2.99-3.6) months after surgery. Long-term after afferent limb stricture surgery, recurrent small bowel obstruction symptoms recurred in 7 (35%) patients 3.9 (2.6-5.8) years later. CONCLUSION: Afferent limb stricture can be treated effectively with salvage surgery. The surgical intervention appears durable and provides an acceptable outcome for their obstructive symptoms.

Gracilis Muscle Interposition for the Treatment of Rectovaginal Fistula: A Systematic Review and Pooled Analysis.

BACKGROUND: A rectovaginal fistula is a debilitating condition that often severely impacts quality of life. Despite many treatment options available, the best surgical treatment is far from being established, and many patients will undergo several procedures before fistula closure is achieved. Gracilis muscle interposition, which is the transposition of the gracilis muscle into the rectovaginal septum, is an option for complex and persistent fistulas, but literature on the subject is scarce, mainly consisting of small case series. OBJECTIVE: This study aimed to assess the success rate of gracilis muscle interposition for the surgical treatment of rectovaginal fistula. DATA SOURCES: MEDLINE, Embase, Cochrane Library, and Web of Science. STUDY SELECTION: Studies comprising at least 5 patients who underwent gracilis muscle interposition for rectovaginal fistula were included. No date or language restrictions was applied. INTERVENTION: Gracilis muscle interposition. MAIN OUTCOME MEASURES: The primary outcome is the fistula closure rate (%). Other domains analyzed are stoma closure rate, postoperative complications, quality of life, fecal continence, and sexual function. RESULTS: Twenty studies were included for a total of 384 patients. The pooled fistula closure rate for gracilis muscle interposition was 64% (95% CI, 53%-74%; range, 33%-100%). Risk factors for failure were smoking, underlying Crohn's disease, and more than 2 previous repairs, whereas stoma formation was associated with improved outcomes. Postoperative complications ranged from 0% to 37%, mostly related to surgical site occurrences at the harvest site and perineal area. No deaths occurred. Gracilis muscle interposition improved quality of life and fecal continence, but impairment of sexual function was common. LIMITATIONS: Most of the included studies were small case series. CONCLUSIONS: Gracilis muscle interposition is a safe and moderately effective treatment that could be taken into consideration as second- or third-line therapy for recurrent rectovaginal fistula. REGISTRATION NO: CRD42022319621.

Techniques of perineal hernia repair: A systematic review and meta-analysis.

BACKGROUND: Perineal hernias are rare, underreported and poorly studied complications of extensive pelvic surgeries. Their management is challenging, with currently no treatment algorithm available. METHOD: MEDLINE, EMBASE, Cochrane Library, and Web of Science databases were searched. Studies comprising at least 3 patients who underwent surgical perineal hernia repair were included. The primary outcome was perineal hernia recurrence. The secondary outcomes were overall complications and surgical site occurrences. RESULTS: Twenty-nine studies were included, comprising 325 patients undergoing 347 repairs. Overall complications were 33% (95% confidence interval 24%-43%) in the entire cohort, 31% (19%-44%) after perineal repair, 39% (14%-67%) after abdominal repair, and 36% (19%-53%) after mesh repair (20% with biological, 46% with synthetic mesh). The surgical site occurrence rate was 18% (8%-29%). The overall recurrence rate was 22% (15%-29%). Recurrence after perineal repair was 19% (10%-29%): 20% with mesh (25% with biological, 19% with synthetic), 24% with primary repair, and 39% with flap repair. Recurrence after an abdominal repair was 18% (11%-26%): 16% with laparoscopic, 12% with open, 16% with mesh (24% with biological, 16% with synthetic), 30% with primary, and 25% with flap repair. No significant differences could be found in the meta-analysis regarding overall complications and recurrence. CONCLUSION: Synthetic mesh repair seems to be associated with a lower recurrence rate than other techniques, especially after an abdominal approach. The perineal and abdominal approaches appear to be safe, with similar recurrence rates. The combined approach seems promising, but more evidence is needed.

Surgical Intervention is Effective for the Treatment of Crohn's-related Rectovaginal Fistulas: Experience From a Tertiary Inflammatory Bowel Disease Practice.

BACKGROUND AND AIMS: Rectovaginal fistula occurs in up to 10-20% of women with Crohn's disease, significantly affecting their quality of life. We sought to determine outcomes of single and repeat operative interventions. METHODS: A retrospective review of all adult patients with a Crohn's-related rectovaginal fistula, who underwent an operation between 1995 and 2021, was performed. Data collected included patient demographics, Crohn's-related medical treatment, surgical intervention, postoperative outcomes, and fistula outcomes. RESULTS: A total of 166 patients underwent 360 operations; mean age was 42.8 [+/-13.2] years; 34 [20.7%] patients were current and 58 [35.4%] former smokers. The most commonly performed procedure was: a local approach [n = 160, 44.5%] using fibrin glue, fistulotomy/fistulectomy, or seton placement; followed by a transvaginal/transanal approach [n = 113, 31.4%] with an advancement flap repair [including Martius advancement flap] and episoproctotomy; a transabdominal approach [n = 98, 27.2%] including proctectomy or re-do anastomosis; and finally gracilis muscle interposition [n = 8, 2.2%]. The median number of operative interventions per patient was 2 [1.0-3.0] procedures. The overall fistula healing rate per patient was 71.7% [n = 119] at a median follow-up of 5.5 [1.2-9.8] years. Factors that impaired healing included former smoking (odds ratio [OR] 0.52, 95% confidence interval [CI] 0.31-0.87, p = 0.014) and seton insertion [OR 0.42, 95% CI 0.21-0.83, p = 0.012]. CONCLUSION: Over two-thirds of Crohn's-related rectovaginal fistulas can achieve closure with multiple surgical interventions. Smoking and seton usage negatively affect healing rates and should be avoided.

Functional Outcomes and Quality of Life After Transanal Total Mesorectal Excision for Rectal Cancer: A Prospective Observational Study.

BACKGROUND: Few studies have addressed the functional impact after transanal total mesorectal excision. OBJECTIVE: This study aimed to evaluate function and health-related quality of life among patients with rectal cancer treated with transanal total mesorectal excision. DESIGN: Consecutive patients treated between 2016 and 2018 were selected. Their function and quality of life were studied preoperatively and at 3 and 12 months after surgery. SETTING: This is a prospective case series. PATIENTS: Patients were eligible if they had primary anastomosis, their diverting stoma had been reversed, and they did not have anastomotic leakage. Forty-five patients were finally included. A total of 31 (68.8%) and 32 patients (71.1%) completed the 3- and 12-month surveys. INTERVENTIONS: Standard transanal total mesorectal excision was performed. MAIN OUTCOME MEASURES: The primary end point was functional and quality-of-life outcomes using validated questionnaires. Secondary end points included values obtained with endoanal ultrasounds, anorectal manometries, and rectal sensation testing. RESULTS: Wexner and Low Anterior Resection Syndrome scores significantly increased 3 months after surgery but returned to baseline values at 12 months. The rate of "major low anterior resection syndrome" at the end of follow-up was 25.0% (+11.7% compared with baseline, p = 0.314). Sexual and urinary functions remained stable throughout the study, although a meaningful clinical improvement was detected in male sexual interest. Among quality-of-life domains, all deteriorations returned to baseline values 12 months after surgery, except worsening of flatulence symptoms, and improvement in insomnia and constipation. At 12 months, an expected decrease in the mean width of the internal sphincter, the anal resting pressure, and the tenesmus threshold volume was found. LIMITATIONS: This study was limited by its small sample size, the absence of a comparative group, and significant missing data in female sexual difficulty and in ultrasounds and manometries at 3 months. CONCLUSIONS: Patients undergoing transanal total mesorectal excision report acceptable quality-of-life and functional outcomes 12 months after surgery. See Video Abstract at http://links.lww.com/DCR/B541. RESULTADOS FUNCIONALES Y CALIDAD DE VIDA DE LOS PACIENTES DESPUS DE LA ESCISIN MESORRECTAL TOTAL TRANSANAL PARA CNCER DE RECTO UN ESTUDIO PROSPECTIVO OBSERVACIONAL: ANTECEDENTES:Pocos estudios han abordado el impacto funcional después de la escisión mesorrectal total transanal.OBJETIVO:Evaluar la función y la calidad de vida relacionada con la salud en pacientes con cáncer de recto tratados con escisión mesorrectal total transanal.DISEÑO:Se seleccionaron pacientes consecutivos tratados entre 2016 y 2018. Se estudió su función y calidad de vida, en la etapa preoperatoria, a los tres y doce meses postoperatorios.METODO:Serie de casos prospectivos.PACIENTES:Los pacientes eran incluidos en presencia de anastomosis primaria, cierre del estoma de derivación y en ausencia de fuga anastomótica. Finalmente se incluyeron cuarenta y cinco pacientes. Un total de 31 (68,8%) y 32 pacientes (71,1%) completaron las encuestas de tres y doce meses, respectivamente.INTERVENCIONES:Escisión mesorrectal total transanal estándar.PRINCIPALES MEDIDAS DE RESULTADO:Los criterio de evaluación principal fueron los resultados funcionales y de calidad de vida mediante cuestionarios previamente validados. Los criterios de evaluación secundarios incluyeron los valores obtenidos con ecografía endoanal, manometría anorrectal y prueba de sensibilidad rectal.RESULTADOS:La escala de Wexner y el síndrome de resección anterior baja aumentaron significativamente tres meses después de la cirugía, pero volvieron a los valores iniciales a los doce meses. La tasa de "síndrome de resección anterior inferior grave" al final del seguimiento fue del 25,0% (+ 11,7% en comparación con el valor inicial, p = 0,314). La función sexual y urinaria se mantuvo estable durante todo el estudio, aunque se detectó una mejora clínica significativa en la libido masculina. Entre los criterios que evalúan la calidad de vida, todas las alteraciones en la misma volvieron a los valores iniciales, doce meses después de la cirugía, excepto el aumento de flatulencia, la mejoría del insomnio y el estreñimiento. A los doce meses, se encontró una disminución esperada en el grosor medio del esfínter interno, la presión anal en reposo y el volumen umbral para la presencia de tenesmo.LIMITACIONES:Tamaño de muestra limitado, ausencia de un grupo comparativo, falta significativa de datos para identificar la dificultad para la actividad sexual femenina y el efectuar ecografía y manometría a los tres meses.CONCLUSIONES:Los pacientes sometidos a escisión mesorrectal total transanal refieren una calidad de vida y resultados funcionales aceptables a los doce meses después de la cirugía. Consulte Video Resumen en http://links.lww.com/DCR/B541.

Transanal total mesorectal excision for stage II or III rectal cancer: pattern of local recurrence in a tertiary referral center.

BACKGROUND: For mid and low rectal cancer, transanal total mesorectal excision (TaTME) has been established as an alternative approach to laparoscopic surgery. However, there are concerns about an unexpected pattern of local recurrence. This study aimed to analyze the pattern of local recurrence for patients treated with TaTME in a tertiary referral center. METHODS: A retrospective single-center analysis was performed. Since 2011, all patients with rectal cancer undergoing TaTME with curative intent were prospectively included in a standardized database. Patients with tumors within 12 cm, clinical stage II or III were included. The primary endpoint of the study was the overall local recurrence rate, together with a critical analysis of the patterns of local failures. RESULTS: Two hundred and five patients were included in this analysis. At the time of surgery, patients had a mean age of 67.1 years (SD 12.3), and 66.8% were male. Neoadjuvant therapy was administered in 73.7%. Mesorectal specimen quality was complete or near-complete in 98.5%, while circumferential resection margin was ≤ 1 mm (including T4 tumors) in 11.8%. After a median follow-up of 34.3 months (95% CI 30.1-38.5), 3.4% (n = 7) presented with local recurrent disease. Six out of the seven patients were also diagnosed with hematogenous metastases. Of the seven patients, three presented with at least one of the following risk factors: T4 tumor, N2 disease, incomplete mesorectal specimen, or positive CRM. Local failure was noted posteriorly (n = 3), laterally (n = 2), anteriorly (n = 1), and in the axial compartment (n = 1). Median time to relapse was 31.5 months (10.3-40.9). The median follow-up after local recurrence was 7.9 (95% CI 6.7-9.1) months, with an overall survival of 85.7%. CONCLUSIONS: TaTME provided satisfactory local recurrence outcomes, and the most common patterns of failure were in the central pelvis.

Multifocal hepatic cystic mass as first manifestation of metastatic spinal hemangiopericytoma.

INTRODUCTION: Hemangiopericytomas (HPCs) are rare vascular tumors with a high malignant potential. Hepatic metastases from HPC are very infrequent and usually show a distinctive solid aspect with a surrounding pseudocapsule. PRESENTATION OF CASE: A 37-year-old man with a previous medical history of recurrent spinal hemangiopericytoma with a 9cm×7cm cystic hepatic mass detected on follow-up. Contrast enhanced US and MRI confirmed the presence the lesion showing mixed (solid and cystic) content. Parasitic and viral serology plus serum tumoral markers (CEA, ca 19.9, ca 125, AFP) tests, upper and lower endoscopy and general laboratory tests were normal and extended left lobectomy was performed. Histopathologic study confirmed the diagnosis of multifocal metastasic hemangiopericytoma with moderate CD-34, CD-99 and Bcl-2 positivity after immunohistochemical staining. After 1-year follow-up the patient does not present any evidence of abdominal recurrence but a skull base recurrence has been detected. DISCUSSION: Liver metastasis from spinal HPC are uncommon and do not have cystic appearance so radiologic diagnosis can be challenging. In spite of the presence of previously diagnosed HPC context, the presence of a liver cystic mass in a young patient makes necessary to discard a number much more frequent benign and malignant diagnosis before metastatic disease can be confirmed. CONCLUSION: The presence of a cystic hepatic mass makes it mandatory to rule out a number neoplasms other than metastasic HPC before a definitive diagnosis is made. In addition to local radiotherapy and antiangiogenic agents, surgery can be useful to treat liver dissemination.