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.

Resección laparoendoscópica de tumor de la unión gastroesofágica / Laparoendoscopic resection of a tumor of the gastroesophageal junction

RESUMEN La resección gástrica atípica ha demostrado ser beneficiosa para tumores submucosos. La técnica pre senta mayor riesgo cuando estos se desarrollan próximos a la unión esófago-gástrica (UEG). Para esta limitación se propuso la resección intragástrica mediante una técnica mixta combinando laparoscopia y endoscopia. En nuestro medio no existen publicaciones al respecto. Se trata de una mujer de 42 años, con lesión subepitelial-subcardial de 2 cm, evaluada mediante videoendoscopia alta (VEDA), compa tible con tumor del estroma gastrointestinal (GIST) evaluado mediante ecoendoscopia. La lesión fue resecada mediante abordaje combinado laparoendoscópico. Bajo visión laparoscópica se introdujeron en cavidad abdominal trocares con balón, y bajo visión endoscópica intragástrica se introdujeron estos en el estómago y se fijó la pared gástrica a la pared abdominal insuflando dichos balones. Posterior mente se realizó la resección de la lesión con sutura mecánica. El abordaje combinado es seguro y eficaz, simple en manos entrenadas, pero constituye una opción reproducible en casos seleccionados.

ABSTRACT Atypical gastric resection has proved to be beneficial to treat submucosal tumors. The technique is more difficult when these tumors develop next to the gastroesophageal junction (GEJ). Intragastric resection combining endoscopic and laparoscopic approach was proposed to solve this limitation. There are no publications about this technique in our environment. A 42-year-old female patients with a 2-mm subepithelial tumor below the cardia evaluated by upper gastrointestinal (UGI) videoendoscopy and endoscopic ultrasound suggestive of a gastrointestinal stroma tumor (GIST) underwent resection using the combined laparo-endoscopic approach. Under laparoscopic guidance, balloon-tipped trocars were introduced in the abdominal cavity and then into the stomach using endoscopic view. The balloons were inflated to fix the gastirc wall to the abdominal wall. The lesion was resected using mechanical stapler. The combined approach is safe and efficient, and simple to perform for trained professionals, constituting a reproducible option in selected cases.

Umbilical laparoendoscopic partial cystectomy.

OBJECTIVE: To present our center's experience in single-port umbilical laparoendoscopic partial cystectomies, in both benign and malignant pathologies. Patient characteristics, perioperative aspects and the surgical techniques used are reviewed. MATERIAL AND METHOD: Since May 2012, five patients have undergone a transumbilical single-port laparoendoscopic partial cystectomy with curved equipment through a reusable multichannel system and a 3.5mm accessory trocar. Patients were three males and two females aged between 28 and 78 (median: 44±42.5) years. The etiologies were endometriosis (in 2 cases), a tumor in the diverticulum, a congenital bladder diverticulum and ureterocele (1 case of each). RESULTS: Median surgery time was 273±163.4minutes, and intraoperative bleeding 250±175ml. None of the patients required transfusion. The postoperative period was uneventful, with good results and no complications. The hospital stay was 3±1 days. With monitoring of 20±17.5 months, morphological and functional recovery in the bladder and ureter was confirmed in all cases and the patient with neoplastic disease was disease-free more than 2 years after the surgery. CONCLUSIONS: An umbilical laparoendoscopic partial cystectomy represents a viable surgical option and ensures that excellent surgical and cosmetic results are achieved.

Transumbilical laparoendoscopic single-site ureteral reimplantation.

OBJECTIVE: To analyze the outcomes of umbilical laparoendoscopic single-site (LESS) ureteral reimplantation using a reusable single-port platform. MATERIAL AND METHOD: The casuistic of LESS ureteral reimplantation in 5 patients is presented. The surgical technique using KeyPort system (reusable umbilical single-site platform) is described. Dissection, suctioning and suturing by minilaparoscopy through 3.5mm accessory port in the iliac fossa are performed. Operative and postoperative outcomes are presented. The median follow-up at time of analysis was 11 ± 14 months. RESULTS: The median age of patients was a 49 ± 34 year; male-female ratio was 1:1.15. Left surgery was carried out in all cases. In 4 patients, the etiology was secondary to stenosis (3 iatrogenic and 1 pelvic endometriosis). In the remaining case, the procedure was performed after excision of a symptomatic adult ureterocele. In all cases, bladder catheter and double-J ureteral catheter were inserted for 7 ± 3 and 30 ± 15 days and then removed. No conversion to convectional laparoscopic or open surgery occurred. The surgery time was 145 ± 60 min, and intraoperative bleeding was 100 ± 75 cc. Neither transfusion nor high analgesia was necessary. No postoperative complications, minor or major, have been reported. Hospital stay was 2 ± 0.5 days. In any patient, restenosis or worsening of renal function occurred. CONCLUSIONS: In experimented centers, transumbilical laparoendoscopic single-site ureteroneocystostomy is a safe alternative with comparable results to conventional laparoscopy and an excellent cosmetic result at low cost thanks to device reuse.

The best option: Umbilical LESS radical nephrectomy with vaginal extraction.

INTRODUCTION: Umbilical laparoendoscopic single-site (LESS) surgery represents an excellent alternative to laparoscopic or robotic multiport surgery. LESS surgery offers faster recovery, less postoperative pain and optimal cosmetic results. The reusable nature of its instruments also has significant economic advantages. PATIENT AND METHOD: We present a 34-year-old patient with a solid mesorenal lesion measuring 8 cm in the left kidney treated with pure LESS radical nephrectomy assisted by vaginal extraction of the specimen. The umbilical approach using a single-site multichannel KeyPort (Richard Wolf GmbH, Knittlingen, Germany) with DuoRotate curved instruments allows for minimum crushing and fewer spatial conflicts. Its perfect umbilical adaptation provides a hermetic system. The instrument's double rotation provides considerable movement precision. Vaginal extraction avoids damage to the abdominal wall and the need for widening the umbilical incision. RESULTS: After the placement of the device and triangulation of the clips, we proceeded to operate on posterior parietal peritoneum. The descending colon was mobilized to access the retroperitoneum and dissect the renal hilum. Hem-o-lok clips were placed on the artery and vein, which were subsequently sectioned. The specimen was inserted into a laparoscopic bag. Under direct vision, we placed a 15-mm trocar through the bottom of the vaginal posterior fornix to facilitate the extraction of the bag's thread. The incision was widened with the fingers, and the specimen was extracted, closing the vagina from the perineum with visualization from the navel. Abdominal drainage was not employed. The surgical time was 180 min. The patient was discharged the following day without needing analgesia. A year later, the patient was disease-free and had no complications. CONCLUSIONS: Umbilical LESS radical nephrectomy with vaginal extraction is feasible in selected cases. The procedure is oncologically safe, avoids scars and facilitates early recovery. From a practical point of view, this approach greatly simplifies natural orifice transluminal endoscopic surgery (NOTES) and enables a minimally invasive equivalent result.

Laparoendoscopic single-site retroperitoneal lymph node dissection in non-seminomatous germ cell malignancy.

INTRODUCTION: Umbilical laparoendoscopic single-site (LESS) surgery represents an excellent alternative to laparoscopic or robotic multiport surgery. LESS surgery offers faster recovery, less postoperative pain and optimal cosmetic results. LESS is possible in virtually any urologic surgery. PATIENT AND METHOD: We present a 38-year-old male with BMI 31.2 and with history of stage I nonseminomatous mixed germ cell tumor showing interaortocaval lymph node recurrence without elevation of tumor markers. Patient was undergone to right laparoendoscopic single-site retroperitoneal lymph node dissection (LDRP-LESS) by umbilical approach using a single-site multichannel KeyPort (Richard Wolf GmbH, Knittlingen, Germany). RESULTS: After the placement of the device and triangulation of the clips, we proceeded to operate on posterior parietal peritoneum. The descending colon was mobilized to access the retroperitoneum. Complete retroperitoneal lymph node dissection on the right side from iliac vessels to renal vessels, including the paracaval and interaortocaval space, was performed. The specimen was inserted into a laparoscopic bag and was removed together with multichannel system. Abdominal drainage was not employed. Surgical time was 85 min and estimated bleeding 50 cc. The patient was very satisfied with the cosmetic results and was discharged the following day without needing analgesia. The pathology report revealed metastatic seminoma in 5 of 11 lymph nodes receiving systemic chemotherapy (VP16-CDDPs) for 4 cycles with good tolerance. A year later, the patient was disease-free and had no complications. CONCLUSIONS: Umbilical primary LDRP-LESS, with excellent oncologic and cosmetic results, is feasible in selected cases. This approach could be considered the least invasive surgical option economically advantageous due to the reusable nature of the instruments used.

[Choledocholithiasis and pregnancy. Hybrid laparo-endoscopic treatment in one step]. / Coledocolitiasis y embarazo. Tratamiento hibrido laparo-endoscópico en una etapa.

BACKGROUND: Complications associated with choledocholithiasis are uncommon during pregnancy. However, when it occurs, the morbidity and mortality related for the product and the mother increases, so a proper treatment is imperative in these patients. CLINICAL CASE: A 25-year-old pregnant woman on her second trimester. The current condition was started four days prior to the hospital admission with abdominal pain in the right upper quadrant with nausea and vomit.Twenty-four hours later jaundice and dark urine is observed. Physical examination shows scleral jaundice, right upper quadrant abdominal pain without peritoneal irritation. Uterus at umbilicus level without uterine activity. Uterus at umbilicus level without uterine activity. Laboratory tests showed elevated bilirubin and transaminases without leukocytosis; ultrasound reported live intrauterine unique product, with a heart rate of 128 beats per minute, gallbladder with multiple images inside that cast acoustic shadowing, and a 10 mm common bile duct dilated bile duct with dilatation of intrahepatic bile ducts. It was perform laparoscopic cholecystectomy with intraoperative cholangiography and placement of a transcystic jaguar guide for selective cannulation of the common bile duct. Intraoperative endoscopic retrograde cholangiopancreatography was performed with endoscopic stone extraction. The outcome was satisfactory with a hospital discharge at 48 hours. CONCLUSION: Current evidence has shown that the combined use of laparoscopy and therapeutic endoscopic cholangiography in one step is effective for the treatment of choledocholithiasis, decreasing the risk of complications associated with cannulation of the bile duct.

Antecedentes: las complicaciones asociadas con la coledocolitiasis son poco comunes durante el embarazo. Sin embargo, cuando aparecen incrementan la morbilidad y mortalidad para el feto y la madre. Caso clínico: paciente femenina de 25 años de edad, en el segundo trimestre de embarazo. El padecimiento actual lo inició cuatro días previos a su ingreso al hospital, con dolor abdominal en el hipocondrio derecho acompañado de náuseas y vómito. A las 24 horas se agregó ictericia y coluria. A la exploración física se encontró tinte ictérico, dolor en el hipocondrio derecho, sin irritación peritoneal. Útero a nivel de la cicatriz umbilical, sin actividad uterina. Los exámenes de laboratorio mostraron: elevación de bilirrubinas y transaminasas, sin leucocitosis; el ultrasonido reportó producto único vivo intrauterino, con frecuencia cardiaca de 128 latidos por minuto, vesícula biliar con múltiples litos en su interior, colédoco 10 mm y dilatación de vía biliar. Se realizó colecistectomía laparoscópica y colangiografía transoperatoria con colocación de guía transcística para canulación selectiva de la vía biliar. Durante la colangiografía endoscópica transoperatoria se extrajeron algunos litos. La evolución fue satisfactoria, toleró la dieta y fue fue dada de alta del hospital a las 48 horas. Conclusión: en el tratamiento de la coledocolitiasis y embarazo la combinación de laparoscopia y colangiografía endoscópica terapéutica en un solo tiempo es eficaz porque disminuye el riesgo de complicaciones asociadas con la canulación de la vía biliar.