Envisioning the future of colorectal surgery: preclinical assessment and detailed description of an endoluminal robotic system (ColubrisMX ELS).

BACKGROUND: The EndoLuminal Surgical System (ELS) is an emerging non-linear robotic system specifically designed for transanal surgery that allows for excision of colorectal neoplasia and luminal defect closure. METHODS: An evaluation of ELS was conducted by a single surgeon in a preclinical setting at the EndoSurgical Center of Florida in Orlando, between October 1st, 2020 and December 31st, 2020, using porcine colon as a model. Mock lesions measured 2.5 to 3.5 cm were excised partial-thickness. Specimen quality and excision time was assessed and evaluated. RESULTS: Twenty consecutive robotic transanal minimally invasive surgery (TAMIS) operations utilizing the ELS system were successfully performed without fragmentation. The mean and standard deviation procedure time for all 20 cases was 18.41 ± 14.15 min. The latter 10 cases were completed in substantially less time, suggesting that ELS requires at least 10 preclinical cases for a surgeon to become familiar with the technology. A second task, namely suture closure of the partial-thickness defect, was performed in 9 of the 20 cases. Mean time and standard deviation for this task measured 27.89 ± 10.07 min. There were no adverse events. CONCLUSIONS: ELS was successful in performing the tasks of partial-thickness disc excision and closure in a preclinical evaluation. Further study is necessary to determine its clinical applicability.

Resultados quirúrgicos y oncológicos de pacientes operados por cáncer de recto con asistencia robótica / Surgical and oncological results of patients operated for rectal cancer with robotic assistance

Resumen Objetivo: Analizar los resultados quirúrgicos y oncológicos de pacientes con adenocarcinoma de recto (AR) operados con asistencia robótica. Materiales y Método: Cohorte prospectiva entre 2014-2019. Criterios de inclusión: pacientes con AR primario, sometidos a una resección de recto con asistencia robótica con intención curativa. Criterios de exclusión: histología no adenocarcinoma. Evaluación de datos clínico-quirúrgicos. Análisis estadístico descriptivo. Resultados: Se incluyeron 37 pacientes; 20 (54%) fueron hombres y la edad promedio fue 58,7 años. La distancia promedio desde el margen anal al borde distal del tumor fue 6,6 cm (i: 2-12 cm). La quimiorradioterapia (neoadyuvancia) se indicó en 26 pacientes. La cirugía más frecuente fue la resección anterior baja de recto y el tiempo operatorio promedio fue 266 min. Se realizaron dos conversiones a laparotomía. Una o más complicaciones se observaron en 17 (45,9%) pacientes, 9 de ellos fueron Clavien-Dindo III o IV y se reoperaron 5 pacientes (13%). No hubo transfusiones sanguíneas ni mortalidad posoperatoria. La estancia hospitalaria postoperatoria promedio fue 9,6 días (i: 3-34 d). El promedio de linfonodos resecados fue 15 (i 4-45). Los márgenes quirúrgicos fueron negativos en todos los pacientes. Se restituyó el tránsito intestinal en 28/32 (87,5%) pacientes. El promedio de seguimiento fue 21 meses (1-56), la sobrevida global y libre de enfermedad fue 100%. Discusión y Conclusión: La proctectomía con asistencia robótica ha demostrado ser segura en términos de resultados quirúrgicos tempranos y en criterios oncológicos de la pieza operatoria.

Aim: To analyze the surgical and oncological results of patients with rectal adenocarcinoma (RA) operated with robotic assistance. Materials and Method: Prospective cohort study, consecutive sample of patients between 2014-2017. Inclusion criteria: patients with primary RA, undergoing rectal resection, with robotic assistance with curative intention. Exclusion criteria: histology not adenocarcinoma. Evaluation of clinical-surgical data. Descriptive statistical analysis. Results: 37 patients were included; 20 (54%) were men and average age was 58.7 years. The average distance from the anal margin to the distal edge of the tumor was 6.6 cm (2-12 cm). Chemoradiotherapy (neoadyuvant) was indicated in 26 patients. The most frequent surgery was low anterior resection of the rectum and the average operating time was 266 minutes. Two conversions to laparotomy were performed. One or more complications were observed in 17 (45.9%) patients, 9 of them were Clavien-Dindo III or IV, 5 patients (13%) were reoperated. There were no blood transfusions and no postoperative mortality. The average postoperative hospital stay was 9.6 days (3-34). The average of resected lymph nodes was 15. Surgical margins were negative in all patients. Intestinal transit was restored in 28/32 (87.5%) patients. The average follow-up was 21 months (1-56), the overall and disease-free survival was 100%. Discussion and Conclusion: Proctectomy with robotic assistance has proved to be safe in terms of early surgical results and oncologic indicators of the surgical piece.

Initial clinical experience with a powered circular stapler for colorectal anastomosis.

BACKGROUND: The Echelon circular™ powered stapler (ECP stapler) obviates the need for manual firing of conventional circular staplers during the construction of a colorectal anastomosis, but has not been evaluated clinically. The aim of this study was to perform a clinical evaluation of this stapler. METHODS: A retrospective review of the initial clinical experience of a single surgeon using the ECP stapler for left-sided colorectal anastomosis construction during elective colorectal resections for benign and malignant disease was conducted by analyzing results from a prospectively maintained study database. Additionally, four attending colorectal and/or general surgeons who had performed ≥ 5 colorectal operations with the ECP stapler were invited to complete an anonymous online survey to subjectively assess the user experience with the device. Statistical analysis was conducted using Microsoft Excel Version 15.33. RESULTS: Seventeen patients underwent left-sided anastomotic reconstruction using the ECP stapler. All donuts (proximal and distal) were intact. Anastomotic integrity was evaluated using the air-leak test utilizing flexible video sigmoidoscopy. No leaks were observed, although one patient (5.9%) developed a postoperative pelvic abscess. The anonymous survey was completed by all four surgeons. Subjective evaluation of the ECP stapler suggests that the overall stapling quality, overall device ease-of-use, and the overall perception of anastomotic quality as above average when compared to manual 'end-to-end anastomosis' (EEA) stapling devices. CONCLUSIONS: In an initial clinical evaluation of the ECP stapler, the safety and ease-of-use of the device appears to be satisfactory. Powered stapling and the design of '3D stapling' may provide advantages over manual systems, and may improve the construction quality of left-sided colorectal anastomosis.

Robotic-assisted stereotactic real-time navigation: initial clinical experience and feasibility for rectal cancer surgery.

BACKGROUND: Real-time stereotactic navigation for transanal total mesorectal excision has been demonstrated to be feasible in small pilot series using laparoscopic techniques. The possibility of real-time stereotactic navigation coupled with robotics has not been previously explored in a clinical setting. METHODS: After pre-clinical assessment, and configuration of a robotic-assisted navigational system, two patients with locally advanced rectal cancer were selected for enrollment into a pilot study designed to assess the feasibility of navigation coupled with the robotic da Vinci Xi platform via TilePro interface. In one case, fluorescence-guided surgery was also used as an adjunct for structure localization, with local administration of indocyanine green into the ureters and at the tumor site. RESULTS: Each operation was successfully completed with a robotic-assisted approach; image-guided navigation provided computed accuracy of ± 4.5 to 4.6 mm. The principle limitation encountered was navigation signal dropout due to temporary loss of direct line-of-sight with the navigational system's infrared camera. Subjectively, the aid of navigation assisted the operating surgeon in identifying critical anatomical planes. The combination of fluorescence with image-guided surgery further augmented the surgeon's perception of the operative field. CONCLUSIONS: The combination of stereotactic navigation and robotic surgery is feasible, although some limitations and technical challenges were observed. For complex surgery, the addition of navigation to robotics can improve surgical precision. This will likely represent the next step in the evolution of robotics and in the development of digital surgery.

Direct target NOTES: prospective applications for next generation robotic platforms.

BACKGROUND: A new era in surgical robotics has centered on alternative access to anatomic targets and next generation designs include flexible, single-port systems which follow circuitous rather than straight pathways. Such systems maintain a small footprint and could be utilized for specialized operations based on direct organ target natural orifice transluminal endoscopic surgery (NOTES), of which transanal total mesorectal excision (taTME) is an important derivative. METHODS: During two sessions, four direct target NOTES operations were conducted on a cadaveric model using a flexible robotic system to demonstrate proof-of-concept of the application of a next generation robotic system to specific types of NOTES operations, all of which required removal of a direct target organ through natural orifice access. These four operations were (a) robotic taTME, (b) robotic transvaginal hysterectomy in conjunction with (c) robotic transvaginal salpingo-oophorectomy, and in an ex vivo model, (d) trans-cecal appendectomy. RESULTS: Feasibility was demonstrated in all cases using the Flex® Robotic System with Colorectal Drive. During taTME, the platform excursion was 17 cm along a non-linear path; operative time was 57 min for the transanal portion of the dissection. Robotic transvaginal hysterectomy was successfully completed in 78 min with transvaginal extraction of the uterus, although laparoscopic assistance was required. Robotic transvaginal unilateral salpingo-oophorectomy with transvaginal extraction of the ovary and fallopian tube was performed without laparoscopic assistance in 13.5 min. In an ex vivo model, a robotic trans-cecal appendectomy was also successfully performed for the purpose of demonstrating proof-of-concept only; this was completed in 24 min. CONCLUSIONS: A flexible robotic system has the potential to access anatomy along circuitous paths, making it a suitable platform for direct target NOTES. The conceptual operations posed could be considered suitable for next generation robotics once the technology is optimized, and after further preclinical validation.

Impacto de las filtraciones anastomóticas en cirugía colorrectal / Impact of anastomotic leak in colorectal surgery

Introducción: La filtración de anastomosis es una de las complicaciones de mayor impacto en cirugía colorrectal. Objetivo: Analizar la frecuencia e impacto de las filtraciones anastomóticas en cirugía laparoscópica colorrectal. Material y método: Estudio longitudinal de base de datos prospectiva de pacientes operados por cirugía colorrectal entre julio de 2007 y agosto de 2014. Resultados: De un total de 654 pacientes operados, 52,3% correspondían a hombres con una edad promedio de 57 años (42-72). La indicación más frecuente fue cáncer colorrectal con 244 pacientes, 159 (24,3%) operados por cáncer de colon y 85 (12,9%) por cáncer de recto, seguido por la enfermedad diverticular con 239 pacientes (36,5%) y 171 pacientes (26,1%) con otros diagnósticos. En 44 pacientes (6,7%) se objetivó filtración anastomótica, con una mediana de 4 días desde el postoperatorio para su diagnóstico. Como factores asociados a filtración se identificó al género masculino, riesgo anestesiológico según ASA, necesidad de conversión a laparotomía y la anastomosis ileoanal. En relación con el tratamiento, 15 pacientes (33,7%) fueron tratados de forma médica exitosa y 29 fue necesario reintervenirlos, de los cuales 23 (79,3%) requirieron una ostomía de protección. No hubo mortalidad asociada a la cirugía, y el promedio de hospitalización en los pacientes con filtración fue de 12 vs. 5 días para los pacientes sin filtración de la anastomosis. Conclusión: Este trabajo permite identificar a grupos de pacientes con mayor riesgo de filtraciones anastomóticas, quienes duplican su estadía hospitalaria y en un alto porcentaje deben ser reintervenidos. La sospecha y diagnostico precoz reducen la morbimortalidad.

Introduction: Anastomotic leak is the most important complication on colorectal surgery. Objective: Analyze the frequency and impact of anastomotic leaks in laparoscopic colorectal surgery. Material and methods: Longitudinal study of prospective database of patients undergoing colorectal surgery between July 2007 and August 2014. Results: 654 patients operated, 52.3% were men with an average age of 57 years (42-72). The most frequent indication was colorectal cancer in 244 patients, 159 (24.3%) operated for colon cancer and 85 (12.9%) for rectal cancer followed by diverticular disease in 239 patients (36.5%) and 171 patients (26.1%) with other diagnoses. In 44 patients (6.7%) anastomotic leakage was observed with a median of 4 days post surgery for diagnosis. As factors associated with filtration, we identified male gender, anesthesic risk according to ASA, need for conversion to laparotomy and ileoanal anastomosis. With regard to treatment, 15 (33.7%) were successfully treated with medical therapy alone and 29 required re-intervention, of which 23 (79.3%) required an ostomy protection. There was no mortality associated with surgery and average LOS was 12 vs. 5 days in patients with filtration compared with patients without anastomotic leakeage. Conclusion: This serie helps to identify patients groups with increased risk of anastomotic leakage who double their hospital LOS and in a higher percentage should need re-intervention. Suspicion and early diagnosis reduces morbidity and mortality.

Transanal hemorrhoidal dearterialization (THD): a safe procedure for the anticoagulated patient?

BACKGROUND: Approximately one in five persons living in the USA is maintained on oral anticoagulation. It has typically been recommended that anticoagulation be withheld prior to hemorrhoidal procedures. Transanal hemorrhoidal dearterialization (THD) is a minimally invasive treatment for symptomatic hemorrhoids, and outcomes with patients on anticoagulation who have undergone this procedure have not been previously reported. Here, we report our preliminary results of patients who underwent THD while on anticoagulation. METHODS: During a 53-month period (February 2009-July 2015), patients with symptomatic hemorrhoids refractory to medical management who underwent surgical treatment with THD were retrospectively reviewed. The subset of patients who underwent THD while anticoagulated was compared to a cohort of patient who were not taking anticoagulation and who otherwise demonstrated normal coagulation profiles and who did not have a known predisposition to bleeding or inherited coagulopathy. The primary study endpoint was to assess postoperative bleeding in patients who were maintained on anticoagulation before and after surgery. RESULTS: During the 53-month study period, 106 patients underwent the THD procedure for symptomatic hemorrhoids. Of these, seventy patients underwent THD without anticoagulation therapy, while 36 patients underwent THD while taking one or more oral anticoagulants. The postoperative morbidity between the two cohorts was similar, and specifically there was no statistical difference in the rate of postoperative hemorrhage (19.4 vs. 15.7 %; odds ratio 1.295, 95 % CI 0.455-3.688, p = 0.785). No patient, in either cohort, required re-intervention for any reason during the study period. Patients who underwent THD while on anticoagulation were less likely to have recurrent hemorrhoidal disease during the study's 6-month median follow-up period (2.8 vs. 7.1 %, p = 0.049). CONCLUSIONS: These preliminary data reveal that THD can be performed on anticoagulated patients without cessation of oral agents without increasing morbidity from postoperative bleeding.

Transanal total mesorectal excision for rectal cancer: early outcomes in 50 consecutive patients.

AIM: Minimally invasive approaches to proctectomy for rectal cancer have not been widely adopted due to inherent technical challenges. A modification of traditional transabdominal mobilization, termed transanal total mesorectal excision (TaTME), has the potential to improve access to the distal rectum. The aim of the current study is to assess outcomes following TaTME for rectal cancer. METHOD: This is a retrospective analysis of a prospectively maintained database of consecutive patients who underwent TaTME for rectal cancer at a single institution. The study period was from 1 March 2012 to 31 July 2015. RESULTS: During the study period 50 patients underwent TaTME. The median tumour distance from the anal verge was 4.4 (3.0-5.5) cm. The rate of conversion from a planned minimally invasive approach was 2.2%. The median operative time was 267.0 (227.0-331.0) min. The median lymph node yield was 18.0 (12.0-23.8), the macroscopic quality assessment of the resected specimen was incomplete in 2% and the circumferential resection margin positivity rate was 4%. Intra-operative morbidity occurred in 6% and the 30 day morbidity rate was 36%. The median length of stay was 4.5 (4.0-8.0) days. The median follow-up was 15.1 (7.0-23.2) months; two patients have developed a local recurrence and eight patients have developed distant recurrence. CONCLUSION: These data suggest that TaTME for rectal cancer is feasible with an acceptable pathological outcome and morbidity profile. Further data on functional and long-term survival outcomes are required.

Relación entre el grado de incontinencia fecal y el daño del esfínter anal externo / Relationship between faecal incontinence severity and external anal sphincter disruption

Introduction: Faecal incontinence (FI) represents an important psychological and social condition for an individual. There are several causes for FI, therefore its study and management is complex. Among different aetiologies, anatomical disruption of the external anal sphincter (EAS) as a consequence of anorrectal surgery or obstetric injury can be studied by endoanal ultrasound (EAUS). This study focus on anatomical assessment of sphincter muscle injury of EAS and its relationship with clinical presentation con FI. Objective: Compare anatomical and disruption of EAS features studied by 3D-EAUS between patients with FI, according to its severity. Methods: 3D-EAUS images were obtained from selected patients studied for FI between January 2008 and July 2010 at Clínica las Condes. Wexner Score (SW) was used to evaluate severity of FI, dividing patients into two categories: Mild FI (SW < 9) and Severe FI (SW ≥ 9). A single observer evaluated different morphological variables: width, length, percentage and angle of EAS disruption. Parametrical and non-parametrical analysis was used as appropriate. P-value < 0.05 was considered statistically significant. Results: From 31 female patients studied, mean SW was 11.7 +/- 0.8 points, range from 5 to 20 points. When dividing into two groups, 9 patients had mild FI and 22 had severe FI. Studied variables in EAUS 3D cubes: width, length, percentage and angle of EAS disruption, did not reach statistical significance between groups. Conclusion: No relationship was found between external anal sphincter anatomic injury variables studied and severity of faecal incontinence.

Introducción: La incontinencia fecal (IF) se refleja en una condición psicológica y social importante para el individuo. Las causas de IF son múltiples, siendo su estudio y manejo complejo. La disrupción anatómica del esfínter anal externo (EAE), secundaria, entre otras, a cirugía anorrectal o lesión obstétrica, es posible de ser estudiada por endosonografía anal (EAUS). El presente artículo se centra en el daño anatómico del EAE y su relación con la presentación clínica de la IF. Objetivo: Comparar las características anatómicas y daño del EAE objetivadas mediante endosonografía en 3 dimensiones (EAUS3D), entre los pacientes con IF según su severidad. Material y Método: Se obtuvo las EAUS3D realizadas en Clínica Las Condes por estudio de IF entre enero de 2008 y julio de 2010. Se utilizó el score de Wexner (SW) para separar la población en dos grupos, IF leve (SW < 9) e IF grave (SW ≥ 9). Un único observador evaluó las diferentes variables: grosor, longitud, porcentaje de defecto y ángulo de lesión del EAE. Se utilizó estadística paramétrica o no-paramétrica según corresponda. Se consideró significativo p < 0,05. Resultados: De un total de 31 pacientes femeninas estudiadas, el SW promedio fue de 11,7 +/- 0,8 con rango entre 5 y 20 puntos. Al separar según grupos, 9 pacientes tenían IF leve y 22 IF grave. De las variables estudiadas por EAUS3D: el promedio, grosor, longitud, porcentaje de defecto y el ángulo de lesión del EAE no lograron diferencia estadística entre los grupos. Conclusión: No existe una relación directa entre las variables estudiadas de daño anatómico del EAE y el grado de IF.

Image-guided real-time navigation for transanal total mesorectal excision: a pilot study.

BACKGROUND: Frameless stereotaxy for real-time, image-guided surgery has been most utilized for neurological and orthopedic surgery. Recently, our center has reported the application of real-time navigation for transanal total mesorectal excision. METHODS: During a 5-month period (June 2013-October 2013), three male patients underwent transanal minimally invasive surgery for total mesorectal excision with image-guided real-time navigation during the transanal portion of the operation. This was completed using a frameless stereotactic navigational system as shown in a demonstration video. Male patients with anterior, locally advanced rectal cancer were selected for enrollment into the pilot study. RESULTS: Three male patients (mean age 69) underwent transanal total mesorectal excision with stereotactic navigation during a 5-month study period. Mean operative time was 402 min, and there were no intra-operative complications recorded. The mean distance from anal verge of the tumor was 6.3 cm (range 4-8 cm). The navigational accuracy was computed to be ±3.69 mm (range ±3.20 to ±4.02 mm). The average navigation setup time was 47 min, not including scan time. The surgical specimens were found to have completely intact mesorectal envelopes (Quirke 3) in all cases. All margins, including radial and distal margins, were negative. Mean postoperative length of stay was 5 days. At a median of 18-month follow-up, there was no evidence of locoregional recurrence or distant metastatic disease. CONCLUSION: This is the first pilot series to report the use of frameless stereotactic navigation for TAMIS-TME. Stereotactic navigation for transanal total mesorectal excision is shown to be feasible, and may aid in providing colorectal surgeons with the ability to better perform safe, high-quality surgery in select cases.

Robotic transanal surgery for local excision of rectal neoplasia, transanal total mesorectal excision, and repair of complex fistulae: clinical experience with the first 18 cases at a single institution.

BACKGROUND: Robotic transanal surgery represents a natural evolution of transanal minimally invasive surgery. This new approach to rectal surgery provides the ability to perform local excision of rectal neoplasia with precision. Robotic transanal surgery can also be used to perform more advanced procedures including repair of complex fistulae and transanal total mesorectal excision. METHODS: Data from patients who underwent transanal robotic surgery over a 33-month period were retrospectively reviewed. Patients underwent three types of procedures using this approach: (a) local excision of rectal neoplasia, (b) transanal total mesorectal excision, and (c) closure of complex fistulae, such as rectourethral fistulae. RESULTS: Eighteen patients underwent robotic transanal surgery during the 33-month study period. Of these, nine patients underwent local excision of rectal neoplasia; four patients underwent transanal total mesorectal excision; four patients underwent repair of rectourethral fistulae; and one patient underwent repair of an anastomotic fistula. Of the patients undergoing robotic transanal surgery for local excision, 6/9 were resections of benign neoplasia, while 3/9 were resections for invasive adenocarcinoma. There was no fragmentation (0/9) noted on any of the locally excised specimens, while one patient (1/9) had a positive lateral margin. During the mean follow-up of 11.4 months, no recurrence was detected. Four patients underwent robotic-assisted transanal total mesorectal excision for curative intent resection of rectal cancer confined to the distal rectum. Mesorectal quality was graded as complete or near complete, and an R0 resection was performed in all four cases. Other transanal robotic procedures performed were the repair of rectourethral fistulae (n = 3) and anastomotic fistula (n = 1). This approach was met with limited success, and only half of the rectourethral fistulae were closed. CONCLUSIONS: Robotic transanal surgery for local excision, transanal total mesorectal excision, and repair of fistulae is feasible, although these new approaches represent a work-in-progress. Improvement in platform design will likely facilitate the ability to perform more complex procedures. Further research with robotic transanal approaches is necessary to determine whether or not this approach can provide patients with significant benefit.