Functional Outcomes After Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: Results from the Phase II North American Multicenter Prospective Observational Trial.

OBJECTIVE: To investigate fecal incontinence and defecatory, urinary, and sexual functional outcomes after taTME. SUMMARY BACKGROUND DATA: Proctectomy for rectal cancer may result in alterations in defecatory, urinary, and sexual function that persist beyond 12 months. The recent multicenter Phase II taTME trial demonstrated the safety of taTME in patients with stage I-III tumors. METHODS: Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence (FIQL, Wexner), defecatory function (COREFO), urinary function (IPSS), and sexual function (FSFI-female, IIEF-male) were assessed preoperatively (PQ), 3-4 months post-ileostomy closure (FQ1), and 12-18 months post-taTME (FQ2). RESULTS: Among 83 patients who responded at all three time points, FIQL, Wexner, and COREFO significantly worsened post-ileostomy closure. Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved, while FIQL depression and embarrassment did not change. IPSS did not change relative to preoperative scores. For females, FSFI declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, IIEF declined with no change between FQ1 and FQ2. CONCLUSIONS: Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains improved by 12 months after ileostomy closure, without returning to preoperative status. Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient expectations and inform shared decision-making regarding taTME.

Longitudinal Analysis of Local Recurrence and Survival After Transanal Abdominal Transanal Radical Proctosigmoidectomy for Low Rectal Cancer Treated With Neoadjuvant Chemoradiation Therapy.

BACKGROUND: The transanal abdominal transanal radical proctosigmoidectomy was developed in 1984 as a sphincter preservation surgery in patients with low rectal cancers after preoperative radiation therapy. While serving as a catalyst for disruptive sphincter preservation surgery, it continues to be used and evolve. With the controversy over safety and local recurrence in other sphincter-preserving surgery, review of transanal abdominal transanal radical proctosigmoidectomy long-term oncologic outcomes is warranted. OBJECTIVE: To assess local recurrence and survival after transanal abdominal transanal radical proctosigmoidectomy after neoadjuvant chemoradiation therapy. DESIGN: Retrospective cohort study of a prospectively maintained database. SETTINGS: Tertiary rectal cancer referral center. PATIENTS: Patients with low adenocarcinoma (≤5 cm anorectal ring) receiving neoadjuvant chemoradiation therapy and then transanal abdominal transanal radical proctosigmoidectomy for curative resection between 1998 and 2021. MAIN OUTCOME MEASURES: Local recurrence rates and overall survival rates. RESULTS: Of 255 included patients, 67.8% were men (n = 173); the mean age was 58.7 years (SD 11.5) and the mean BMI was 27.1 (SD 5.4), with 50.2% (n = 128) having ASA class II and 49.8% (n = 127) having ASA class III/IV. The mean tumor size was 4.8 cm (SD 1.9), the majority of patients had clinical T3 disease (81.8%; n = 184), and 52.1% had nodal disease (n = 100). The median radiation dose was 5400 cGy, with 73.7% (n = 149) achieving good response and 90.2% (n = 230) receiving minimally invasive surgery. The complete total mesorectal excision rate was 94.3%, and 100% of patients (n = 255) had negative distal margins. The mean number of examined lymph nodes were 13.9 (SD 10.7). After a median follow-up of 55.4 months, 5.1% of patients (n = 13) developed local recurrence at a median time of 29.6 months. The 5-year overall survival was 84.1% (95% CI, 78.8-89.4). LIMITATIONS: Retrospective review with risk of bias and lack of generalizability. CONCLUSIONS: In this longitudinal study, the transanal abdominal transanal radical proctosigmoidectomy demonstrated excellent long-term locoregional control and survival in very low rectal cancers. The superior transanal abdominal transanal radical proctosigmoidectomy outcomes are durable over time, warranting expansion of the sphincter-preserving surgery technique. See Video Abstract . ANLISIS LONGITUDINAL DE LA RECURRENCIA LOCAL Y LA SUPERVIVENCIA DESPUS DE LA PROCTOSIGMOIDECTOMA RADICAL TRANSANAL ABDOMINAL TATA PARA EL CNCER DE RECTO BAJO TRATADO CON QUIMIORRADIACIN NEOADYUVANTE: ANTECEDENTES:La proctosigmoidectomía radical transanal abdominal se desarrolló en 1984 como una cirugía de preservación del esfínter en cánceres de recto bajo después de la radiación preoperatoria. Si bien sirve como catalizador para la cirugía disruptiva de preservación del esfínter, continúa utilizándose y evolucionando. Con la controversia sobre la seguridad y la recurrencia local en otras cirugías que preservan el esfínter, se justifica la revisión de los resultados oncológicos a largo plazo de la proctosigmoidectomía radical transanal abdominal.OBJETIVO:Evaluar localmente después de Proctosigmoidectomía Radical Transanal Abdominal Transanal después de quimiorradiación neoadyuvante.DISEÑO:Estudio de cohorte retrospectivo de una base de datos mantenida de forma prospectiva.AJUSTES:Centro terciario de referencia para el cáncer de recto.PACIENTES:Adenocarcinoma bajo (=/

Safety and Efficacy of a Novel Miniaturized Robotic-Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework.

BACKGROUND: Robotics has increased rates of minimally invasive surgery, with distinct advantages over open surgery. However, current commercially available robotic platforms have device and system issues that limit robotic-assisted surgery expansion. OBJECTIVE: To demonstrate the safety and efficacy of a novel miniaturized robotic-assisted surgery device in colectomy. DESIGN: Prospective, Investigational Device Exemption clinical study following the idea, development, exploration, assessment, and long-term follow-up framework (stage 2b, exploration). SETTINGS: Three centers with high-volume robotic colorectal cases and surgeons. PATIENTS: Patients scheduled for a right or left colectomy for benign or malignant disease. INTERVENTION: Colectomy with the novel miniaturized robotic-assisted surgery device. MAIN OUTCOME MEASURES: For safety, intraoperative and device-related adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion. RESULTS: Thirty patients (13 women, 17 men) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent of patients (n = 21) were overweight/obese and 53.3% of patients (n = 16) had prior abdominal surgery. Forty percent of patients had malignant and 60% had benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was a median of 146 (range, 80-309) minutes; console time was 70 (range, 34-174) minutes. There were no conversions to open surgery and no intraoperative or device-related adverse events. In 100% of patients (n = 30), the primary dissection was completed, and hemostasis was maintained with the novel miniaturized robotic-assisted surgery device. The morbidity rate was 26.7% minor and 3.3% major. The median length of stay was 2 days. There were no mortalities. LIMITATIONS: Single-arm study, short-term follow-up. CONCLUSIONS: This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated that it was safe and effective. Given this success, further assessment and long-term follow-up of the miniaturized robotic-assisted surgery device are planned for comparative clinical and economic effectiveness in colorectal surgery. See Video Abstract . SEGURIDAD Y EFICACIA DE UN NOVEDOSO SISTEMA DE CIRUGA ASISTIDA POR ROBOT MINIATURIZADO EN COLECTOMA UN ESTUDIO CLNICO PROSPECTIVO DE INVESTIGACIN DE EXENCIN DE DISPOSITIVO QUE UTILIZA EL MARCO IDEAL: ANTECEDENTES:La robótica ha aumentado las tasas de cirugía mínimamente invasiva, con claras ventajas sobre la cirugía abierta. Sin embargo, las plataformas robóticas actualmente disponibles comercialmente tienen problemas con los dispositivos y sistemas que limitan la expansión de la cirugía asistida por robot.OBJETIVO:Demostrar la seguridad y eficacia de un novedoso dispositivo de cirugía asistida por robot miniaturizado en colectomía.DISEÑO:Estudio clínico prospectivo de investigación de exención de dispositivo siguiendo el marco IDEAL (Etapa 2b, exploración).ESCENARIO:Tres centros con cirujanos y casos colorrectales robóticos de gran volumen.PACIENTES:Pacientes programados para colectomía derecha o izquierda por enfermedad benigna o maligna.INTERVENCIÓN:Colectomía con el nuevo dispositivo de cirugía asistida por robot miniaturizado.PRINCIPALES MEDIDAS DE RESULTADO:Para la seguridad, eventos adversos intraoperatorios y relacionados con el dispositivo y morbilidad a 30 días. Para la evaluación de la eficacia, la finalización exitosa de los pasos predefinidos sin conversión.RESULTADOS:Se analizaron treinta pacientes (13 mujeres, 17 hombres). La edad media fue 59,4 (DE 13,4) años. El 70% (n=21) tenía sobrepeso/obesidad y el 53,3% (n=16) había tenido cirugía abdominal previa. El 40% tenía enfermedad maligna y el 60% benigna. Los casos fueron 15 colectomías derechas y 15 izquierdas. La mediana del tiempo operatorio general fue de 146 (rango, 80-309) minutos; 70 (rango, 34-174) minutos fue el tiempo de consola. No hubo conversiones a cirugía abierta ni eventos adversos intraoperatorios o relacionados con el dispositivo. En el 100% (n=30), se completó la disección primaria y se mantuvo la hemostasia con el novedoso dispositivo de cirugía asistida por robot miniaturizado. La tasa de morbilidad menor fue de un 26,7% y mayor un 3,3%. La mediana de estadía fue de 2 días. No hubo mortalidad.LIMITACIONES:Estudio de un solo brazo, corto plazo de seguimiento.CONCLUSIONES:Este primer estudio clínico de un novedoso dispositivo de cirugía asistida por robot miniaturizado según el marco IDEAL demostró que era seguro y eficaz. Dado este éxito, se planean evaluaciones adicionales y seguimiento a largo plazo del dispositivo de cirugía asistida por robot miniaturizado para comparar la efectividad clínica y económica en la cirugía colorrectal. (Traducción-Dr. Felipe Bellolio ).

Comparing advanced platforms for local excision of rectal lesions.

BACKGROUND: Transanal surgery facilitates organ preservation in select patients with benign and early malignant rectal lesions to avoid the functional consequences of radical surgery. The transanal endoscopic microsurgery (TEM) platform created a standard for local excision with lower margin positivity and recurrence rates than traditional transanal excision. The single-port robot (SP r) presents a promising alternative transanal platform. The goal of this study was to compare perioperative and pathologic outcomes of TEM and SP r for excision of rectal lesions. METHODS: A review of consecutive patients who underwent local excision of rectal lesions at a tertiary referral center from 1/2001 to 5/2022 was performed. Cases were stratified into TEM or SP rTAMIS in a 1:1 propensity score-matched cohort, adjusting for all baseline characteristics. Clinical, tumor-specific, and perioperative outcomes were compared using χ2, and Mann-Whitney U-tests. The main outcomes were oncologic quality measures, complications, and operative time. RESULTS: Matching resulted 50 patients in each cohort. Groups had similar age, gender, body mass index, comorbidity, diagnosis, lesion characteristics, and neoadjuvant chemoradiation rates. There were no intraoperative complications in either cohort. Three SP rTAMIS cases were converted intraoperatively; there were no conversions in TEM. SP rTAMIS had significantly shorter operative times than TEM (mean 104 vs. 245, p = 0.027). The rates of positive distal margins (2% TEM, 0% SP rTAMIS) and piecemeal resection (4% TEM, 0% SP rTAMIS) were similar. SP rTAMIS had significantly lower postoperative morbidity rates than TEM (9% vs. 20%, p = 0.031). There was no mortality in either cohort. CONCLUSIONS: SP robotics provided high-quality outcomes similar to TEM for local excision of rectal lesions. SP robotics had faster operative time with comparable clinical and oncologic outcomes to TEM. These early data are promising for expanding use of SP robotic platforms.

Oncologic outcomes following transanal total mesorectal excision: the United States experience.

AIM: The benefits and short-term outcomes of transanal total mesorectal excision (taTME) for rectal cancer have been demonstrated previously, but questions remain regarding the oncologic outcomes following this challenging procedure. The purpose of this study was to analyze the oncologic outcomes following taTME at high-volume centers in the USA. METHODS: This was a multicenter, retrospective observational study of 8 tertiary care centers. All consecutive taTME cases for primary rectal cancer performed between 2011 and 2020 were included. Clinical, histopathologic, and oncologic data were analyzed. Primary endpoints were rate of local recurrence, distal recurrence, 3-year disease recurrence, and 3-year overall survival. Secondary endpoints included perioperative complications and TME specimen quality. RESULTS: A total of 391 patients were included in the study. The median age was 57 years (IQR: 49, 66), 68% of patients were male, and the median BMI was 27.4 (IQR: 24.1, 31.0). TME specimen was complete or near complete in 94.5% of cases and the rates of positive circumferential radial margin and distal resection margin were 2.0% and 0.3%, respectively. Median follow-up time was 30.7 months as calculated using reverse-KM estimator (CI 28.1-33.8) and there were 9 cases (2.5%) of local recurrence not accounting for competing risk. The 3-year estimated rate of disease recurrence was 19% (CI 15-25%) and the 3-year estimated overall survival was 90% (CI 87-94%). CONCLUSION: This large multicenter study confirms the oncologic safety and perioperative benefits of taTME for rectal cancer when performed by experienced surgeons at experienced referral centers.

A prospective phase II clinical trial/IDEAL Stage 2a series of single-port robotic colorectal surgery for abdominal and transanal cases.

AIM: Slow laparoscopy adoption accelerated the uptake of robotic surgery. However, the current robotic platforms have limitations in transanal applications and multiple port sites. The da Vinci single-port (SP) robot is currently used on trial for colorectal surgery, and broad assessment of outcomes is needed. We aimed to report findings of a phase II clinical trial of SP robotic colorectal surgery. METHODS: A sequentially reported prospective case series was performed on patients using SP robotics at a tertiary referral centre from 1 October 2018 to 31 August 2021. Cases were stratified into abdominal and transanal cohorts. Demographics, intra-operative variables and 30-day postoperative outcomes were evaluated. Univariate analysis was performed, with statistical process control for the docking process. Main outcomes were conversion rates, morbidity, mortality and point of standardization of docking. RESULTS: In all, 133 patients were included: 93 (69.92%) abdominal and 40 (30.08%) transanal. The main diagnosis was rectal cancer (n = 59) and the procedure performed a robotic transanal abdominal transanal radical proctosigmoidectomy (n = 30). There were no conversions to open surgery. Two abdominal (2.15%) and three transanal cases (7.50%) were converted to laparoscopy. All colorectal adenocarcinomas had negative margins, proper lymph node harvest and complete mesorectal excision, as appropriate. Docking became a standardized process at cases 34 (abdominal) and 23 (anorectal). After surgery, bowel function returned on mean day 2 (abdominal) and 1 (transanal). The morbidity rate was 15.05% (abdominal) and 27.50% (transanal). There were two major morbidities in each cohort. Overall, there were three (2.65%) readmissions, one reoperation and no mortality. CONCLUSIONS: Single-port robotics is feasible for all types of colorectal procedures, with good clinical and oncological outcomes. With this development in colorectal surgery, further studies can develop best practices with this novel technology.

First Clinical Experience With Single-Port Robotic Transanal Minimally Invasive Surgery: Phase II Trial of the Initial 26 Cases.

BACKGROUND: Many transanal platforms have been developed to address the challenge of reach and vision when operating transanally. The single-port robot was specifically designed for narrow-aperture surgery and is a promising platform for minimally invasive transanal surgery. OBJECTIVE: The purpose of this phase II trial is to evaluate the safety and feasibility of the initial clinical experience with single-port robot transanal minimally invasive surgery. DESIGN: In a prospective phase II trial, patients with rectal neoplasms eligible for local excision were enrolled for single-port robotic transanal minimally invasive surgery. SETTING: The study was conducted between October 2018 and March 2020 at a tertiary referral hospital. PATIENTS/INTERVENTION: Twenty-six consecutive patients underwent single-port robotic transanal minimally invasive surgery resection of rectal lesions. MAIN OUTCOME MEASURES: The primary end point of the study was the efficacy and safety of single-port robotic transanal minimally invasive surgery. RESULTS: There were 13 men and 13 women, with an average lesion size of 2.9 cm (range, 1.0-6.0 cm) and average level of 4.8 cm from the anorectal ring (range, 0-30 cm). Ten patients had a preoperative diagnosis of adenocarcinoma, 7 of whom received neoadjuvant chemoradiation (range, 4500-5580 cGy with concurrent oral capecitabine). Eighty-eight percent of cases were completed by single-port robotic transanal minimally invasive surgery; 2 were converted to transanal endoscopic microsurgery, and 1 patient underwent a low anterior resection. There were no piecemeal extractions, and all margins were negative on final pathology. There were no mortalities, and the morbidity rate was 15.4%. There have been no local recurrences, with a mean follow-up of 5.8 months (range, 0-15.9 months). LIMITATIONS: The study was limited by small sample size, short-term follow up, and a single-surgeon experience. CONCLUSION: Single-port robotic transanal minimally invasive surgery procedures are safe and feasible in patients with select benign and malignant rectal lesions. Future trials will need to evaluate the long-term safety and efficacy of single-port robotic transanal minimally invasive surgery. See Video Abstract at http://links.lww.com/DCR/B605. PRIMERA EXPERIENCIA CLNICA CON CIRUGA MNIMAMENTE INVASIVA TRANSANAL ROBTICA DE PUERTO NICO ENSAYO DE FASE II DE LOS CASOS INICIALES: ANTECEDENTES:Se han desarrollado muchas plataformas transanales para abordar el desafío del alcance y la visión cuando se opera de manera transanal. El robot de un solo puerto fue diseñado específicamente para la cirugía de apertura estrecha y es una plataforma prometedora para la cirugía transanal mínimamente invasiva.OBJETIVO:El propósito de este ensayo de fase II es evaluar la seguridad y viabilidad de la experiencia clínica inicial con la cirugía mínimamente invasiva transanal con robot de puerto único.DISEÑO:En un ensayo prospectivo de fase II, los pacientes con neoplasias rectales elegibles para la escisión local se inscribieron para la cirugía mínimamente invasiva transanal robótica de puerto único.AJUSTE:El estudio se realizó entre octubre de 2018 y marzo de 2020 en un hospital de referencia terciario.PACIENTES / INTERVENCIÓN:Veintiséis pacientes consecutivos fueron sometidos a cirugía mínimamente invasiva transanal robótica de puerto único para resección de lesiones rectales.PRINCIPALES MEDIDAS DE RESULTADO:El criterio de valoración principal del estudio fue la eficacia y seguridad de la cirugía mínimamente invasiva transanal robótica de puerto único.RESULTADOS:Hubo 13 hombres y 13 mujeres, con un tamaño de lesión promedio de 2.9 cm (rango 1.0-6.0 cm) y un nivel promedio de 4.8 cm del anillo anorrectal (rango 0-30 cm). Diez pacientes tenían un diagnóstico preoperatorio de adenocarcinoma, 7 de los cuales recibieron quimiorradiación neoadyuvante (rango 4500-5580 cGy con capecitabina oral concurrente). El 88% de los casos se completaron mediante cirugía mínimamente invasiva transanal robótica de puerto único; 2 se convirtieron a microcirugía endoscópica transanal y 1 se sometió a una resección anterior baja. No hubo extracciones parciales y todos los márgenes fueron negativos en la patología final. No hubo mortalidad y una tasa de morbilidad del 15,4%. No ha habido recidivas locales, con un seguimiento medio de 5,8 meses (rango 0-15,9 meses).LIMITACIONES:El estudio estuvo limitado por un tamaño de muestra pequeño, un seguimiento a corto plazo y la experiencia de un solo cirujano.CONCLUSIÓN:Los procedimientos de cirugía mínimamente invasiva transanal robótica de puerto único son seguros y factibles en pacientes con lesiones rectales benignas y malignas seleccionadas. Los ensayos futuros deberán evaluar la seguridad y eficacia a largo plazo de la cirugía mínimamente invasiva transanal robótica de puerto único. Consulte Video Resumen en http://links.lww.com/DCR/B605. (Traducción-Dr. Eduardo Londoño-Schimmer).

Initial clinical experience with Single-Port robotic (SP r) left colectomy using the SP surgical system: description of the technique.

BACKGROUND: The daVinci Single-Port (SP) robot is a new robotic platform designed to overcome the challenges of Single-Incision Laparoscopic Surgery. The objective of this study is to demonstrate the feasibility and technical aspects of SP robotic (SP r) left colectomy using the SP platform. METHODS: Under Institutional Review Board approval and registration on ClinicalTrials.gov, we performed SP rLeft colectomy using the daVinci SP surgical system on four patients. The primary end-point of this study was to report and describe the technical feasibility to perform SP rLeft colectomy. The secondary end-points included perioperative metrics and outcomes. RESULTS: Four patients underwent successful SP rLeft colectomy for diverticulitis through a single incision (average size: 4.4 cm) without intraoperative complications or conversions. The robot was docked 2.7 times on average (range 2-4). The average docking time was 8.4 min (range: 3-33 min). The mean estimated blood loss was 91 mL (range: 20-250 mL). There were no morbidities or mortalities. Patients were discharged on POD 2 and 3. CONCLUSION: We demonstrated in this initial clinical series the SP rLeft colectomy to be feasible and safe to perform in select patients. The SP robot's single-arm design and flexible instruments have shown to provide excellent visualization and retraction with minimal collisions. We predict that the SP robot will be widely utilized in the field of colorectal surgery as it becomes available to colorectal surgeons. Further experience and larger studies are needed to define the advantages and identify the problems with the SP rLeft colectomy.

Robotic Transanal Surgery for Rectal Cancer.

Robotic transanal surgery is the culmination of major developments in rectal cancer management and minimally invasive surgery. It is the result of continuous efforts to tackle the challenges inherent to rectal cancer surgery. This latest technology holds great promise and excitement for the care of the rectal cancer patient. In this article, we will describe the evolution of transanal rectal cancer surgery and describe how the convergence of transanal transabdominal, transanal endoscopic microsurgery, transanal minimally invasive surgery (TAMIS), transanal total mesorectal excision (taTME), and the different robotic platforms have culminated in the development of single port robotic transanal minimally invasive surgery (SP rTAMIS) and single port robotic transanal total mesorectal excision (SP rtaTME). We will describe the indications, technical aspects, outcomes, benefits, and limitations of the SP rTAMIS and SP rtaTME.

Cannabinoids: A Guide for Use in the World of Gastrointestinal Disease.

Cannabinoids have been known as the primary component of cannabis for decades, but the characterization of the endocannabinoid system (ECS) in the 1990s opened the doors for cannabis' use in modern medicine. The 2 main receptors of this system, cannabinoid receptors 1 and 2, are found on cells of various tissues, with significant expression in the gastrointestinal (GI) tract. The characterization of the ECS also heralded the understanding of endocannabinoids, naturally occurring compounds synthesized in the human body. Via secondary signaling pathways acting on vagal nerves, nociceptors, and immune cells, cannabinoids have been shown to have both palliative and detrimental effects on the pathophysiology of GI disorders. Although research on the effects of both endogenous and exogenous cannabinoids has been slow due to the complicated legal history of cannabis, discoveries of cannabinoids' treatment potential have been found in various fields of medicine, including the GI world. Medical cannabis has since been offered as a treatment for a myriad of conditions and malignancies, including cancer, human immunodeficiency virus/acquired immunodeficiency syndrome, multiple sclerosis, chronic pain, nausea, posttraumatic stress disorder, amyotrophic lateral sclerosis, cachexia, glaucoma, and epilepsy. This article hopes to create an overview of current research on cannabinoids and the ECS, detail the potential advantages and pitfalls of their use in GI diseases, and explore possible future developments in this field.

Transanal Surgery: A History of taTME Ancestry.

Transanal total mesorectal excision (taTME) is the culmination of major developments in rectal cancer management and minimally invasive surgery. This surgical breakthrough holds great promise and excitement for the care of the rectal cancer patient. We would be remiss in discussing taTME to not acknowledge the role of transanal abdominal transanal proctosigmoidectomy, transanal endoluminal microsurgery, laparoscopy, and natural orifice transluminal endoscopic surgery that got us to this modern day explosion of the taTME approach. In this article, we detail and explain the convergence of these disparate experiences, how they culminated in the development of the taTME, and explore future directions in this field.

Quality of Life and Functional Outcome After Transanal Abdominal Transanal Proctectomy for Low Rectal Cancer.

BACKGROUND: Transanal abdominal transanal proctectomy is a sphincter-preserving procedure designed to avoid colostomy in patients with cancer in the distal third of the rectum. Oncologic outcomes of this procedure have been established. However, data regarding patient satisfaction and quality of life are scant. OBJECTIVE: The purpose of this study was to evaluate the quality of life and functional outcomes of patients after transanal abdominal transanal proctectomy. DESIGN: This is a cross-sectional study. SETTINGS: The study was conducted at a tertiary referral colorectal center. PATIENTS: Patients who underwent transanal abdominal transanal proctectomy were included and surveyed using the Fecal Incontinence Quality of Life Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, the Quality of Life Questionnaire CR38 module, and a questionnaire designed by the authors to assess satisfaction with quality of life. MAIN OUTCOME MEASURES: Quality of life, functional outcomes, and patient satisfaction were measured and compared by age, tumor level, and stage of the disease. RESULTS: A total of 133 surveys were mailed, and 90 patients responded and were included in the study. Patient quality of life was not significantly different after surgery. Patients with more proximal tumors had better lifestyle, physical, and emotional scores. Older patients performed better on multiple levels, including coping, emotional, body image, future perspective, and digestive. Stage of disease had no impact on quality of life. Compared with reference values, patients who underwent transanal abdominal transanal proctectomy performed better on most of the components. All of patients preferred transanal abdominal transanal proctectomy over having a stoma based on their current anal sphincter function, and >97% of patients preferred transanal abdominal transanal proctectomy based on their current quality of life, sexual function, and level of activities. LIMITATIONS: This study is limited by the lack of a comparison group and a potential selection bias. CONCLUSIONS: Satisfaction with quality of life and functional outcomes is high after transanal abdominal transanal proctectomy. Older patients and those with more proximal tumors performed better. This patient population clearly preferred a sphincter-preserving option for treatment of their rectal cancer.

Long-term outcomes by a transanal approach to total mesorectal excision for rectal cancer.

BACKGROUND: The challenge of performing a good total mesorectal excision (TME) dissection, particularly in the distal 1/3 of the rectum, has spurred interest in new techniques. Robotic surgery is advocated by some, and more recently, a "new" approach, the transanal total mesorectal excision, has been popularized to address this problem. While great interest in this technique exists, little long-term outcome data are available. We have been utilizing a transanal abdominal transanal approach to TME in order to facilitate the distal dissection, and here, we provide our long-term outcomes using this approach in the management of rectal cancer. METHODS: From a prospectively maintained rectal cancer database, we identified 373 consecutive rectal cancers treated with sphincter preservation surgery through a combined transanal and abdominal approach to TME. Perioperative, pathological, and oncologic outcomes were analyzed. RESULTS: Three hundred and seventy-three patients with rectal cancer underwent a transanally initiated TME with mean follow-up of 5.5 years. 91% of cancers were in the distal rectum. 68.9% were men and 53.2% of cancers were tethered or fixed on presentation. 97.7% received neoadjuvant radiotherapy (mean 5405 cGy, 5-fluorouracil based); average time from completion of neoadjuvant therapy to surgery was 11 weeks. 180 and 193 patients underwent completion of their operation through open and laparoscopic abdominal approaches. 96% of TME specimens were complete/near complete, 94% had a negative circumferential resection margin, and 98.6% had a negative distal margin. Perioperative morbidity and mortality rates were 13.4 and 0.3%. Overall local recurrence (LR), DM, and Kaplan-Meier 5-year actuarial survival were 7.4, 19.5, and 90%, respectively. CONCLUSION: This is the first report of long-term data using a transanal approach to TME supporting this approach for rectal cancer. Our data with 5-year follow-up show that adequate distal and circumferential margins with very good-quality TME specimens, and a low risk for LR with excellent overall survival can be achieved using this technique. Our long-term results support the promising reports of early experiences in the literature.

Outcomes in 132 patients following laparoscopic total mesorectal excision (TME) for rectal cancer with greater than 5-year follow-up.

INTRODUCTION: The role of laparoscopic TME for rectal cancer is still questioned as a safe and adequate cancer operation. Currently, multicenter randomized prospective trials are underway to evaluate this. We analyze our long-term results using laparoscopic TME in the treatment of rectal cancer to evaluate its oncologic outcomes. METHODS: A prospective laparoscopic database was queried to identify all patients operated upon for rectal cancer from April 1997 to September 2007. In total, 151 patients were identified. Metastatic disease excluded 19 patients, leaving 132 patients to be analyzed for perioperative and 5-year oncologic outcomes. Procedures included LAR, n = 35; transanal abdominal transanal proctosigmoidectomy, n = 77; and APR, n = 20. All surgeries were TME or pTME. RESULTS: Laparoscopic TME was performed on 89 men (67%), mean age 61 (22-85). Preoperative chemoradiation was administered in 119 (90.2 %) with median dose of 5500 cGy (3800-10,080). Mean EBL was 300 ml, and 4.5% were transfused. Seven patients (5.3%) underwent conversion, 5 to lap-assisted, with a 1.5% conversion rate to open. Pathologic stage of disease: complete response: 24%; I: 36%; II: 22%; III: 18%. There were no mortalities. Overall morbidity was 23.5%, with no anastomotic leaks and 5 (3.8%) delayed anastomotic stricture/fistula. There were no port site recurrences. Mean follow-up was 69.4 months (7.6-168.0). Overall LR was 5.3% (n = 7). There was only one isolated LR (0.8%). Mean time to local recurrence was 13.9 months. Metastatic rate was 18.2%. By stage, disease-specific survival was: CR 86.3%; I: 87.4%; II: 86.4%; III: 77.4%. Overall, 5-year survival was 84.8%. CONCLUSION: The long-term data confirm that laparoscopic TME can be performed with lasting low local recurrence (5.3 %) and excellent 5-year survival (84.8%). This report's importance stems from it representing one of the largest experiences of rectal cancer treated by laparoscopic TME with greater than 5-year follow-up reported in the literature.

True NOTES TME resection with splenic flexure release, high ligation of IMA, and side-to-end hand-sewn coloanal anastomosis.

INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) represents the ultimate expression of minimally invasive surgery. We have developed and present here an initial feasibility and safety study of transanal total mesorectal excision (TME) with splenic flexure release, high ligation of the IMA and IMV, and side-to-end coloanal anastomosis with temporary diverting ileostomy for rectal cancer. METHODS: A program of full NOTES TME resection with release of the splenic flexure, high ligation of the IMA/IMV, with side-to-end coloanal anastomosis was performed transanally from December 2013 to July 2014. Demographics, preoperative, perioperative, and postoperative data were prospectively obtained. Operative components were broken into TME, colonic mobilization, splenic flexure release, IMA/IMV transection, transanal extraction of specimen, and coloanal anastomosis for analysis of performance completion. RESULTS: There were 3 women and 1 man on whom we operated. Mean age was 56 (46-65). Mean BMI was 26 (23.8-30.2). The operation was completed entirely transanally in 2 patients. Transanal component completion of the operation was as follows: TME in 3/4; colonic mobilization in 4/4; splenic flexure release in 3/4; IMA/IMV transection in 3/4; transanal specimen extraction in 4/4; coloanal anastomosis in 4/4. Abdominal time for completion of component parts was: splenic flexure release 4:53 (min:s), IMA/IMV 19:43, completion of TME 13:41. Mean EBL was 194 cc (25-500). Aside from stoma site, there were no abdominal incisions. There were no mortalities. Mesorectum was intact in all 4 patients and with negative circumferential and distal margins. CONCLUSION: This experience supports the feasibility and safety of a true NOTES TME. The critical anatomic views demonstrated on video affirm the potential of this approach for distal rectal cancer. Colorectal surgery represents the most logical application for NOTES. While highly promising, a great deal of work remains to develop the technique and applicability of NOTES colorectal surgery.

Single-port laparoscopic colorectal surgery shows equivalent or better outcomes to standard laparoscopic surgery: results of a 190-patient, 7-criterion case-match study.

INTRODUCTION: Single-port (SP) surgery has been characterized as having limited applicability regarding procedure, disease, and patient characteristics. There is a question if SP procedures offer disadvantages or advantages to multiport (MP) colorectal surgery. We hypothesize that SP is equivalent to MP and is a safe alternative in the full spectrum of colorectal disease and procedures. METHODS: A case-matched analysis of a prospectively maintained database to compare perioperative outcomes in SP versus MP was performed. Criteria included age, gender, BMI, previous abdominal surgery, previous XRT, disease process, and procedure. 95 exact matches for all 7 criteria were found between 159 SP and 1,617 MP cases. Perioperative outcomes, surgical technique, morbidity, mortality, local recurrence, and 5-year survival were analyzed. RESULTS: There was lower mean EBL in SP but no difference in transfusion requirement. OR time for SP left colectomy was shorter, with a trend to shorter OR times found in all procedures. 99 % SP and 98 % MP had no intra-operative complications. Conversion to open was equivalent (0/1). Mean largest incision was smaller for SP. There were no differences in return of bowel function or length of hospital stay. There were no mortalities. There were no differences in perioperative morbidity, local recurrence, distant metastasis, or overall 5-year survival. CONCLUSIONS: SP is a safe alternative to MP colorectal surgery across the full array of procedures in equivalent patients. This study demonstrates SP has less blood loss, smaller incisions, is quicker in left colectomy, and tends to be quicker across all procedures. Conversion and morbidity rates are equivalent to MP, without compromise in quality of surgical technique. While proper training is essential, concerns regarding the inability to use SP laparoscopic colorectal surgery safely are unfounded in nearly exactly matched patients. These issues will require further study as SP laparoscopic colorectal surgery is practiced more widely.