Ensayo clínico multicéntrico para la resección de pólipos rectales mediante un nuevo dispositivo de acceso transanal híbrido laparoendoscópico / Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device

Introducción: Los pólipos complejos requieren el uso de técnicas endoscópicas avanzadas o la cirugía mínimamente invasiva para su abordaje. En los pólipos rectales es de especial relevancia llegar a un consenso de cuál es el mejor abordaje de estos para evitar infratratamientos o sobretratamientos que incrementen una morbimortalidad innecesaria. Métodos: Se describe un ensayo clínico piloto con un producto sanitario de primer uso en humanos multicéntrico y prospectivo. Se plantea la hipótesis que UNI-VEC® facilita la cirugía laparoendoscópica transanal para la extirpación de tumores rectales precoces. El objetivo principal es evaluar que es seguro y cumple los requisitos funcionales establecidos. Los secundarios son evaluar resultados, complicaciones y nivel de satisfacción.Resultados: Se reclutaron 16 pacientes en 12 meses con un seguimiento mínimo de dos meses. El tamaño medio ha sido de 3,4 cm, siendo el pólipo mayor de 6 cm. Respecto a la localización, la media se encontraba a 6,6 cm del margen anal. Se realizó resección endoscópica mucosa (REM) (6,3%), disección submucosa endoscópica (DSE) (43,8%), resección espesor completo (REC) (6,3%) y transanal minimally invasive surgery (TAMIS) (43,8%). El tiempo medio fueron 73,25 min; 56,3% utiliza una cámara de 30̊ y 43,8% el endoscopio flexible como instrumento de visión. El 56,3% son lesiones benignas y 43,8% malignas. En 87,5% se consigue resección completa. En cuanto a las complicaciones, se presenta sangrado leve (Clavien I) en 25, 6,3 y 21,4% a las 24 h, 48 h y siete días, respectivamente. La continencia se valora según la Escala de Wexner. A los siete días, 60% presentan continencia perfecta, 26,7% IF leve y 13,3% IF moderada. A los 30 días, 66,7% continencia perfecta, 20% IF leve y 13,3% IF moderada. A los dos meses se revisan cuatro de los pacientes que a los 30 días presentaban un Wexner superior al preoperatorio y se demuestra continencia perfecta en 25% de los pacientes, 50% leve y 25% moderada. (AU)

Introduction: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. Methods: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. Results: Sixteen patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic mucosal resection (EMR) (6.3%), endoscopic submucosal dissection (ESD) (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days, respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. (AU)

Multicenter clinical trial for the resection of rectal polyps using a new laparoendoscopic hybrid transanal access device.

INTRODUCTION: Complex polyps require the use of advanced endoscopic techniques or minimally invasive surgery for their approach. In rectal polyps it is of special relevance to reach a consensus on the best approach to avoid under- or overtreatment that increases unnecessary morbidity and mortality. METHODS: We describe a prospective, multicenter, pilot clinical trial with a first-in-human medical device. It is hypothesized that UNI-VEC® facilitates transanal laparoendoscopic surgery for the removal of early rectal tumors. The primary objective is to evaluate that it is safe and meets the established functional requirements. Secondary objectives are to evaluate results, complications and level of satisfaction. RESULTS: 16 patients were recruited in 12 months with a minimum follow-up of 2 months. The mean size was 3.4 cm with the largest polyp being 6 cm. Regarding location, the mean was 6.6 cm from the anal margin. Endoscopic Mucosal Resection (EMR) (6.3%), Endoscopic Submucosal Dissection ESD (43.8%), REC (6.3%) and TAMIS (43.8%) were performed. The mean time was 73.25 min. The 56.3% used a 30° camera and 43.8% used the flexible endoscope as a viewing instrument. The 56.3% were benign lesions and 43.8% malignant. Complete resection is achieved in 87.5%. Regarding complications, mild bleeding (Clavien I) occurred in 25%, 6.3% and 21.4% at 24 h, 48 h and 7 days respectively. Continence was assessed according to the Wexner scale. At 7 days, 60% showed perfect continence, 26.7% mild FI and 13.3% moderate FI. At 30 days, 66.7% had perfect continence, 20% mild FI and 13.3% moderate FI. At 2 months, 4 patients were reviewed who at 30 days had a Wexner's degree higher than preoperative and perfect continence was demonstrated in 25% of the patients, 50% mild and 25% moderate. In no case did rectal perforation or major complications requiring urgent reintervention occur. As for the level of reproducibility, safety, level of satisfaction with the device and evaluation of the blister, the evaluation on a scale of 0-10 (9.43, 9.71, 9.29 and 9.50 respectively). All the investigators have previous experience with transanal devices. CONCLUSIONS: The study demonstrates the efficacy and safety of UNI-VEC® for the treatment of rectal lesions. It will facilitate the implementation of hybrid procedures that seek to solve the limitations of pure endoscopic techniques by allowing the concomitant use of conventional laparoscopic and robotic instrumentation with the flexible endoscope.

Dolor en el cuadrante superior derecho en una mujer joven. Detrás de los cálculos biliares / Right upper quadrant pain in a young woman. Beyond gallstones

We present a medical image that remarks the clinical and radiological key facts that can led to the diagnosis of the relatively uncommon Fitz-Hugh-Curtis syndrome, that might be overlooked if the physician remains unaware of the referred findings. It also enhances the importance of multidisciplinary collaboration when taking care of a patient with an uncommon clinical presentation. (AU)

El declive de la linfadenectomía axilar en el cáncer de mama. Evolución de su indicación durante los últimos 20 años / The decline of axillary lymph node dissection in breast cancer. Evolution of its indication over the last 20 years

Introducción: En los últimos 20 años los procedimientos de estadificación ganglionar en el cáncer de mama se han modificado. El objetivo de este estudio es describir la evolución de estos procedimientos en nuestro centro. Métodos: Estudio prospectivo observacional que incluye a las mujeres con cáncer de mama intervenidas entre el 2001 y el 2017. Se identificaron 4 grupos según el esquema terapéutico utilizado y 3 periodos a estudio definidos por las indicaciones de la linfadenectomía. Resultados: Mil trescientos diecinueve pacientes cumplieron los criterios de inclusión. La cirugía conservadora primaria fue el esquema terapéutico más frecuente (54,13%) y se realizaron 615 linfadenectomías axilares (46,62%) durante los 20 años estudiados. El porcentaje de linfadenectomías axilares disminuyó progresivamente en el tiempo, pasando del 91% en el primer periodo al 34% en el último periodo. Las linfadenectomías axilares fútiles descendieron al 6,6% en el último año. En la cirugía conservadora primaria no se realizó ninguna linfadenectomía axilar fútil los 2 últimos años. Conclusión: La introducción de la biopsia de ganglio centinela en 2001 y de los criterios ACOSOG Z0011 han modificado la indicación de la linfadenectomía axilar. Así, se han disminuido las linfadenectomías axilares sin afectación, evitando la morbilidad que asocia este procedimiento, especialmente linfedema. El estudio refleja el descenso progresivo de la indicación de la linfadenectomía en los diferentes grupos a estudio, similar a lo expuesto por otros autores. En diversos ensayos clínicos se ha descrito que estos cambios no han impactado negativamente en supervivencia

Introduction: In last 20 years, lymph node staging procedures in breast cancer have been modified. The objective of this study is to describe the evolution of these procedures at our hospital. Methods: A prospective observational study that included women with breast cancer who were treated surgically between 2001 and 2017. Four groups were identified according to the therapeutic regimen and 3 study periods defined by the lymph node dissection. Results: 1319 patients met the inclusion criteria. Primary conservative surgery was the most frequent therapy (54.13%), and 615 (46.62%) axillary lymph node dissections (ALND) were performed in the 20-year study period. The percentage of ALND decreased progressively over time, going from 91% in the first period to 34% in the last period. The futile ALND fell to 6.6% in the last year. In the primary conservative surgery, no futile ALND was performed in the last two years. Conclusion: The introduction of sentinel lymph node biopsy and the ACOSOG Z0011 criteria have modified the indication for ALND. Thus, ALND without involvement have been reduced, thereby avoiding the associated morbidity. The study demonstrates the progressive decrease in the indication of lymphadenectomy in the different study groups, similar to reports by other authors. Several clinical trials have described that these changes have not negatively impacted survival

The decline of axillary lymph node dissection in breast cancer. Evolution of its indication over the last 20 years. / El declive de la linfadenectomía axilar en el cáncer de mama. Evolución de su indicación durante los últimos 20 años.

INTRODUCTION: In last 20 years, lymph node staging procedures in breast cancer have been modified. The objective of this study is to describe the evolution of these procedures at our hospital. METHODS: A prospective observational study that included women with breast cancer who were treated surgically between 2001 and 2017. Four groups were identified according to the therapeutic regimen and 3 study periods defined by the lymph node dissection. RESULTS: 1319 patients met the inclusion criteria. Primary conservative surgery was the most frequent therapy (54.13%), and 615 (46.62%) axillary lymph node dissections (ALND) were performed in the 20-year study period. The percentage of ALND decreased progressively over time, going from 91% in the first period to 34% in the last period. The futile ALND fell to 6.6% in the last year. In the primary conservative surgery, no futile ALND was performed in the last two years. CONCLUSION: The introduction of sentinel lymph node biopsy and the ACOSOG Z0011 criteria have modified the indication for ALND. Thus, ALND without involvement have been reduced, thereby avoiding the associated morbidity. The study demonstrates the progressive decrease in the indication of lymphadenectomy in the different study groups, similar to reports by other authors. Several clinical trials have described that these changes have not negatively impacted survival.

Negative Pressure Wound Therapy for a Complicated Abdominal Laparotomy in Neonatal Necrotizing Enterocolitis: A Case Report.

Necrotizing enterocolitis (NEC) is the most common surgical emergency in neonatal intensive care units, and patients who require surgery have high mortality and morbidity rates. The utility of negative pressure in the management of adults with complicated abdominal wounds has been documented, but there are few reports describing the use of negative pressure wound therapy (NPWT) in children or following neonatal surgery. The case of a 6 day old, 5-weeks premature neonate with NEC is presented. An exploratory midline laparotomy was performed on day 3 of life owing to rectal bleeding and abdominal distension that did not respond to gastric decompression, bowel rest, and intravenous antibiotics. Ten (10) cm of necrosis in the distal ileum were noted and resected; in addition, an ileostomy was performed, and a Penrose drain was left in the surgical site. On postoperative day 5, the laparotomy dehisced. Continuous NPWT (50 mm Hg) was initiated and changed owing to patient tolerance to intermittent therapy (5 minutes on, 30 seconds off) at 80 mm Hg. By postoperative day 11, granulation tissue formation was complete. No surgical procedures were required for the complete closure of the abdominal wall, and no adverse reactions were noted. The baby was discharged from the hospital on postop day 15. In this patient, the use of negative pressure was found to be safe and facilitated management of a complicated abdominal wound in the presence of a stoma and the formation of healthy granulation tissue. Additional research is needed to help clinicians provide optimal, evidence-based care for dehisced wounds in this vulnerable population.

Factores que afectan a la recurrencia postoperatoria de la enfermedad de Crohn. Nuevas controversias a través de la experiencia de un centro / No disponible

Introducción Muchos pacientes con enfermedad de Crohn presentan recurrencias frecuentes mientras otros mantienen periodos prolongados de remisión después de la cirugía. Determinar los factores de riesgo de recidiva puede ser útil para identificar pacientes de alto riesgo y poder adoptar estrategias adecuadas durante el acto quirúrgico y en la elección del tratamiento médico postoperatorio. Material y métodos Estudio retrospectivo de 78 pacientes con enfermedad de Crohn ileocólica sometidos a una primera cirugía resectiva durante el periodo de enero de 2000 a diciembre de 2005; posteriormente se han estudiado los factores de riesgo de recurrencia endoscópica, radiológica y quirúrgica hasta mayo de 2009. Resultados 41 pacientes (52,6%) tuvieron recurrencia; siendo en 17 pacientes (21,8%) endoscópica, en 12 (15,4%) radiológica y en 12 (15,4%) quirúrgica. El tiempo medio de la primera recurrencia es de 70,24 meses. El no realizar anastomosis durante la cirugía resectiva parece tener más relación con la existencia de recidiva (77,7% vs 48,2%). Aunque solo la existencia de complicaciones postoperatorias (p=0,018) tiene relación significativa con la existencia de recurrencia (68,4% vs 47,4%) así como la necesidad de transfusión en el periodo postoperatorio inmediato (67,8% vs 42,8%). Conclusiones La transfusión de hemoderivados es un factor de riesgo para la recurrencia postoperatoria de la enfermedad de Crohn. Pero solo las complicaciones postoperatorias se muestran como factor de riesgo independiente en el análisis multivariable. Una técnica quirúrgica adecuada y segura es un factor perioperatorio muy importante en el que podemos influir para disminuir esta recidiva (AU)

Introduction: Many patients with Crohn’s disease have frequent recurrences, while others have long periods of remission after surgery. Determination of the risk factors of recurrence would be useful in identifying these high risk patients and to adopt suitable strategies during the surgical act and in the choice of post-surgical medical treatment. Material and methods: A retrospective study was conducted on 78 patients with ileocolic Crohn’s disease subjected to a first surgical resection, during the period from January 2000 to December 2005. The risk factors for endoscopic, radiological and surgical were subsequently analysed up to May 2009.Results: A total of 41 patients (52.6%) had recurrences, being endoscopic in 17 (21.8%) of patients, radiological in 12 (15.4%) and surgical in 12 (15.4%). The mean time to first recurrence was 70.24 months. Recurrence was associated more to not performing anastomosis(77.7% vs. 48.2%) during surgical resection. Although only the existence of postoperative complications (P = .018) was significantly associated with (68.4% vs. 47.4%), as well as with the need for transfusion in the immediate post-operative period (67.8% vs. 42.8%). Conclusions: Transfusion of blood products is a risk factor for postoperative recurrence of Crohn’s disease. But only postoperative complications are shown as an independent risk factor in the multivariate analysis. An adequate and safe surgical technique is a very important perioperative factor over which we have the influence to decrease these recurrences (AU)