A New Perspective on Vacuum-Assisted Closure for the Treatment of Anastomotic Leak Following Low Anterior Resection for Rectal Cancer, Is It Worthy?

BACKGROUND: Anastomotic dehiscence is a common complication of anterior resection. In this work, we evaluate the management of the pelvic cavity after low rectal resection using vacuum closure (VAC) with a gastroscope, and we establish factors that determine the success of closure and analyzed the rate of ileostomy closure after leakage was resolved. PATIENTS AND METHODS: This is a descriptive case series analysis conducted at a tertiary hospital. Twenty-two patients with low colorectal anastomosis leakage or opening of the rectal stump after anterior resection for rectal cancer were included. They were treated with VAC therapy. RESULTS: The total number of endoscopic sessions was 3.1 ± 1.9 in the anterior resection with anastomosis group and 3.2 ± 1.8 in the Hartmann group. In 11 patients the therapy was administered in an ambulatory setting. The mean time to healing was 22.3 ± 14.7 days. Full resolution was achieved in 19 patients (followed-up 1 year). Ileostomy closure was carried out in 5 patients (38.46%) during follow-up. None of these patients showed leakage signs. Statistically significant differences were obtained depending on the onset of therapy, with better results in patients who underwent earlier vacuum-assisted therapy (before the sixth week after initial surgery), P = .041. CONCLUSIONS: VAC therapy is an alternative to surgery that can be safely administered in an ambulatory setting. Early administration in the 6 weeks following surgery is an independent predictive factor for successful closure; however, colonic transit was only recovered in a small percentage of patients.

Factibility and security study of the PICS-AF™ plug for the treatment of cryptoglandular anal fistula. / Estudio de factibilidad y seguridad del plug de colágeno (PICS-AF™) en el tratamiento de la fístula anal criptoglandular.

INTRODUCTION: The PICS-AF™ (Curaseal Inc.) device is a new plug made of collagen that has a retention system in the internal orifice. This pilot study was designed to assess both the feasibility and safety of this plug in the treatment of trans-sphincteric anal fístulas. METHODS: A total of 44 patients (34 men), with a mean age of 54.68±7.3, with trans-sphincteric anal fístulas were included in the study; 34 of them were analyzed. All patients were examined according to a strict preoperative protocol and until 6 months after surgery. The feasibility of the procedure and the adverse events were analyzed. RESULTS: Finally, 34 patients were operated on, and in 30 of them the plug was used. Therefore, the feasibility was calculated at 88%. There was a total of 16 adverse events, 4recorded as not related (3 mild and one moderate) and 12 related to the procedure or to the device implanted. Of these, 5were mild, 5moderate and 2severe. The majority of the events reported were related to proctalgia (4 patients) or infection at the implant site (4 patients). CONCLUSIONS: The present study indicates that the new collagen plug can be placed effectively and with an acceptable complication rate.

Estudio de factibilidad y seguridad del plug de colágeno (PICS-AF(TM)) en el tratamiento de la fístula anal criptoglandular / Factibility and security study of the PICS-AF(TM) plug for the treatment of cryptoglandular anal fistula

INTRODUCCIÓN: El dispositivo PICS-AF(TM) es un nuevo tapón hecho de colágeno que tiene un sistema de retención en el orificio fistuloso interno. Este estudio piloto ha sido diseñado para evaluar la factibilidad y seguridad de este dispositivo en el tratamiento de las fístulas anales criptoglandulares transesfinterianas. MÉTODOS: Un total de 44 pacientes (34 hombres) con diagnóstico de fístula transesfinteriana fueron incluidos en el estudio, de los cuales 34 fueron seleccionados. Todos los pacientes fueron examinados según un protocolo estricto antes de la cirugía y hasta 6 meses después. Se analizaron la factibilidad del procedimiento y los acontecimientos adversos. RESULTADOS: El dispositivo se colocó sin incidencias en 30 de los 34 pacientes (factibilidad del 88%). Se evidenciaron un total de 16 acontecimientos adversos, 4registrados como no relacionados con el procedimiento (3 leves y uno moderado) y 12 relacionados con el procedimiento o el dispositivo implantado. De ellos, 5fueron leves, 5moderados y 2graves. La mayoría de los efectos adversos reportados fueron proctalgia (4 pacientes) o infección en el sitio del implante (4 pacientes). CONCLUSIONES: El presente estudio indica que el nuevo tapón de colágeno puede ser colocado de forma efectiva y con una tasa de complicaciones aceptable

INTRODUCTION: The PICS-AF(TM) (Curaseal Inc.) device is a new plug made of collagen that has a retention system in the internal orifice. This pilot study was designed to assess both the feasibility and safety of this plug in the treatment of trans-sphincteric anal fístulas. METHODS: A total of 44 patients (34 men), with a mean age of 54.68±7.3, with trans-sphincteric anal fístulas were included in the study; 34 of them were analyzed. All patients were examined according to a strict preoperative protocol and until 6 months after surgery. The feasibility of the procedure and the adverse events were analyzed. RESULTS: Finally, 34 patients were operated on, and in 30 of them the plug was used. Therefore, the feasibility was calculated at 88%. There was a total of 16 adverse events, 4recorded as not related (3 mild and one moderate) and 12 related to the procedure or to the device implanted. Of these, 5were mild, 5moderate and 2severe. The majority of the events reported were related to proctalgia (4 patients) or infection at the implant site (4 patients). CONCLUSIONS: The present study indicates that the new collagen plug can be placed effectively and with an acceptable complication rate

Utilidad de la ecografía dinámica tridimensional en el estudio del suelo pélvico / The role of tridimensional dynamic ultrasound for pelvic floor evaluation

INTRODUCCIÓN: La ecografía endoanal dinámica (EEAD) en 3 dimensiones ha surgido en los últimos años como una alternativa a las pruebas existentes en el diagnóstico de las alteraciones del suelo pélvico. El objetivo de este trabajo es determinar la utilidad de la ecodefecografía en el diagnóstico y evaluación de los pacientes que presentan síntomas de obstrucción defecatoria, así como mostrar los resultados obtenidos tras su implementación en una unidad de suelo pélvico. MÉTODOS: Estudio retrospectivo que analiza a 66 pacientes (61 mujeres), con una edad media de 55 años (19-83). Se realizó una EEAD y se correlacionó con los síntomas y los hallazgos exploratorios en consulta. Se realizó tanto un estudio descriptivo como inferencial, así como un índice Kappa para buscar correlación entre la exploración física y la EEAD. RESULTADOS: Los motivos de consulta fueron: síndrome de obstrucción defecatoria (SOD) 36 pacientes (54,5%), prolapso de órganos pélvicos (POP) 27 pacientes (40,9%) y SOD junto con POP 3 pacientes (4,5%). La correlación de ambos grupos indica que la EEAD diagnostica más pacientes con rectocele grado III, enteroceles y anismos que la combinación de exploración-manometría-proctoscopia-ecografía bidimensional (Kappa 0,26; 0,38 y 0,21; IC 95%: 0,07-1,00; 0,15-1,00 y 0,12-1,00, respectivamente) (p < 0,001). Por el contrario, la EEAD diagnostica menos descensos del periné (Kappa 0,28; IC 95% 0,12-1,00). CONCLUSIÓN: La ecografía dinámica puede tener un papel relevante como prueba complementaria en el paciente con enfermedad del suelo pélvico, ya que permite diagnosticar procesos que mediante la inspección, la exploración física y la manometría pasarían desapercibidos

INTRODUCTION: Dynamic endoanal ultrasound has emerged in recent years as a test that could replace the now existing tests in the diagnosis of pelvic floor disorders. The aim of this paper is to determine the usefulness of echodefecography in the diagnosis and evaluation of patients with symptoms of anorrectal obstruction, and show the results obtained after its implementation in a pelvic floor unit, as a complementary tool that could replace conventional defecography. METHODS: In this retrospective study we analyzed 66 patients with a mean age of 55 years (19-83), 61 women (92%). All dynamic ultrasound was performed in 3 dimensions and was correlated with symptoms and physical findings in the consultation. A descriptive and inferential study was performed to find a kappa correlation between physical examination and echodefecography. RESULTS: The reasons for consultation were: Anorrectal obstruction syndrome 36 patients (54.5%), pelvic organ prolapse 27 patients (40.9%), and anorrectal obstruction syndrome along with pelvic organ prolapse 3 patients (4.5%). The correlation of the 2 groups indicated that echodefecography diagnosed more patients with grade III rectocele, enteroceles, and anismus than the combination of scan-ultrasound-manometry-proctoscopy (Kappa 0.26, 0.38 and 0.21, 95% CI: from 0,07 to 1.00, 0.15 to 1.00 and from 0.12 to 1.00, respectively) (P<.001). Conversely, echodefecography diagnosed less perineal descense (Kappa 0.28, 95% CI: 0.12 to 1.00). CONCLUSIONS: Dynamic anal ultrasonography may have a role as a complementary test in patients with pelvic floor disorders, achieving diagnoses that would go undetected by inspection, physical examination and manometry

The role of tridimensional dynamic ultrasound for pelvic floor evaluation.

INTRODUCTION: Dynamic endoanal ultrasound has emerged in recent years as a test that could replace the now existing tests in the diagnosis of pelvic floor disorders. The aim of this paper is to determine the usefulness of echodefecography in the diagnosis and evaluation of patients with symptoms of anorrectal obstruction, and show the results obtained after its implementation in a pelvic floor unit, as a complementary tool that could replace conventional defecography. METHODS: In this retrospective study we analyzed 66 patients with a mean age of 55 years (19-83), 61 women (92%). All dynamic ultrasound was performed in 3 dimensions and was correlated with symptoms and physical findings in the consultation. A descriptive and inferential study was performed to find a kappa correlation between physical examination and echodefecography. RESULTS: The reasons for consultation were: Anorrectal obstruction syndrome 36 patients (54.5%), pelvic organ prolapse 27 patients (40.9%), and anorrectal obstruction syndrome along with pelvic organ prolapse 3 patients (4.5%). The correlation of the 2 groups indicated that echodefecography diagnosed more patients with grade III rectocele, enteroceles, and anismus than the combination of scan-ultrasound-manometry-proctoscopy (Kappa 0.26, 0.38 and 0.21, 95% CI: from 0,07 to 1.00, 0.15 to 1.00 and from 0.12 to 1.00, respectively) (P<.001). Conversely, echodefecography diagnosed less perineal descense (Kappa 0.28, 95% CI: 0.12 to 1.00). CONCLUSIONS: Dynamic anal ultrasonography may have a role as a complementary test in patients with pelvic floor disorders, achieving diagnoses that would go undetected by inspection, physical examination and manometry.

Analysis of conversion factors in robotic-assisted rectal cancer surgery.

BACKGROUND: Robotic surgical management of rectal cancer has a series of advantages which might facilitate the surgical approach to the pelvic cavity and reduce conversion rates. The aim of the present study is to identify independent factors for conversion during robotic rectal cancer surgery. METHODS: A total of 67 patients underwent preoperative CT scan in order to obtain a three-dimensional image of the pelvis, the tumour and prostate. We measured maximum and minimum ilio-iliac, sacral promontory-pubis, coccyx-pubis diameters and maximum lateral axis. Further variables under consideration were age, BMI and use of neoadjuvant therapy. We recorded short-term follow-up outcomes of the resected tumour. RESULTS: The present study included 67 patients (39 males) with an average age of 65.11 ± 10.30 years and a BMI of 27.70 ± 3.97 kg/m(2). Operative procedures included nine abdominoperineal resections and 58 low anterior resections. There were 15 (22.38 %) conversions. Mean operating time was 192.2 ± 42.73 min. Minimum ilio-iliac, maximum ilio-iliac, promontory-pubic and coccyx-pubis diameter as well as maximum lateral axis were 100.38 ± 7.65, 107.10 ± 10.01, 109.97 ± 9.20, 105.61 ± 9.27 and 129.01 ± 9.94 mm, respectively. Mean tumour volume was 37.06 ± 44.08 cc; mean prostate volume was 42.07 ± 17.49 cc. The univariate analysis of the variables showed a correlation between conversion and BMI and minimum ilio-iliac and coccyx-pubis diameters (p = 0.004, 0.047, 0.046). In the multivariate analysis, the only independent predictive factor for conversion was the BMI (p = 0.004).No correlation was found between conversion and sex, age, tumour volume or the rest of pelvic diameters. CONCLUSION: BMI is an independent factor for conversion in robotic-assisted rectal cancer surgery.

Estudio prospectivo, aleatorizado: cirugía laparoscópica con asistencia robótica versus cirugía laparoscópica convencional en la resección del cáncer colorrectal / Prospective randomised study: robotic-assisted versus conventional laparoscopic surgery in colorectal cancer resection

Introducción La cirugía robótica está tomando protagonismo en los últimos años en el abordaje de la dolencia oncológica colorrectal. Sin embargo, no existen todavía estudios que muestren ventajas objetivas de este tipo de abordaje. Presentamos un estudio prospectivo, aleatorizado cuyo objetivo es comparar los resultados a corto plazo entre la cirugía robótica y la cirugía laparoscópica colorrectal. Material y método Entre enero de 2008 y enero de 2009, 56 pacientes diagnosticados de cáncer colorrectal fueron aleatorizados y asignados al grupo de cirugía robótica o laparoscópica. Se compararon la edad, el índice de masa corporal, la localización tumoral, las conversiones de cada grupo, las complicaciones intra- y postoperatorias y las características histológicas de las piezas obtenidas. Resultados No hubo diferencias significativas en la edad (p=0,055), el índice de masa corporal (p=0,12), o la localización tumoral (p=0,91). Sólo un paciente precisó ser transfundido en el grupo robótico y ninguno en el grupo laparoscópico. El porcentaje de conversiones fue idéntico en ambos grupos, sin embargo el tiempo de preparación y el tiempo operatorio sí fue significativamente mayor en los pacientes intervenidos mediante el dispositivo robótico (p=0,0001 y p=0,017 respectivamente). No existieron diferencias en cuanto al índice de complicaciones ni el porcentaje de reintervenciones (14,2% y 7,1%). La estancia media de los pacientes fue de 9,3±8,1 días en el grupo robótico y de 9,2±6,8 días en el laparoscópico (p=0,79). El margen distal de resección fue mayor en el espécimen obtenido mediante cirugía robótica (p=0,003) así como el número de ganglios obtenidos de la pieza (p=0,23) (AU)

Introduction: Robotic-assisted surgery is playing an increasingly important role in the last few years in the treatment of colorectal oncological disease. However, there are still no studies that objectively demonstrate the advantages of this type of surgery. We present a prospective randomised study in order to compare the short-term results between colorectal robotic surgery and laparoscopic surgery. Material and method: A total of 56 patients diagnosed with colorectal cancer between January2008 and January 2009, were randomised and assigned to the robotic or laparoscopic group. Age, body mass index, tumour location, conversions in each group, complications during and after surgery, and histological characteristics of the specimens obtained, were all compared. Results: There were no significant differences between age (P=.055), body mass index (P=.12),or tumour location (P=.91). Only one patient in the robotic group required a transfusion and none in the laparoscopic group. The percentage of conversions was the same in both groups, however, the preparation times and operating times were significantly longer in patients intervened using the robotic device (P=.0001 and P=.017, respectively). There were no differences as regards the rate of complications or in the percentage of re-interventions(14.2% and 7.1%). The mean hospital stay of the patients was 9.3 (8.1) days in the robotic group and 9.2 (6.8) days in the laparoscopic (P=.79). The distal resection margin was greater in the specimen obtained using robotic surgery (P =.003) as well as the number of lymphnodes obtained in the specimen (P =.23).Conclusion: Robotic colorectal was performed safely and effectively, and with similar clinical results (AU)

[Prospective randomised study: robotic-assisted versus conventional laparoscopic surgery in colorectal cancer resection]. / Estudio prospectivo, aleatorizado: cirugía laparoscópica con asistencia robótica versus cirugía laparoscópica convencional en la resección del cáncer colorrectal.

INTRODUCTION: Robotic-assisted surgery is playing an increasingly important role in the last few years in the treatment of colorectal oncological disease. However, there are still no studies that objectively demonstrate the advantages of this type of surgery. We present a prospective randomised study in order to compare the short-term results between colorectal robotic surgery and laparoscopic surgery. MATERIAL AND METHOD: A total of 56 patients diagnosed with colorectal cancer between January 2008 and January 2009, were randomised and assigned to the robotic or laparoscopic group. Age, body mass index, tumour location, conversions in each group, complications during and after surgery, and histological characteristics of the specimens obtained, were all compared. RESULTS: There were no significant differences between age (P=.055), body mass index (P=.12), or tumour location (P=.91). Only one patient in the robotic group required a transfusion and none in the laparoscopic group. The percentage of conversions was the same in both groups, however, the preparation times and operating times were significantly longer in patients intervened using the robotic device (P=.0001 and P=.017, respectively). There were no differences as regards the rate of complications or in the percentage of re-interventions (14.2% and 7.1%). The mean hospital stay of the patients was 9.3 (8.1) days in the robotic group and 9.2 (6.8) days in the laparoscopic (P=.79). The distal resection margin was greater in the specimen obtained using robotic surgery (P =.003) as well as the number of lymph nodes obtained in the specimen (P =.23). CONCLUSION: Robotic colorectal was performed safely and effectively, and with similar clinical results. International Trial Number for this study is: ISRCTN60866560.