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 transanal total mesorectal excision (taTME). BACKGROUND: 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 to III tumors. METHODS: Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence [Fecal Incontinence Quality of Life (FIQL), Wexner], defecatory function [Colorectal Functional Outcome (COREFO)], urinary function (International Prostate Symptom Score), and sexual function (Female Sexual Function Index-female, International Index of Erectile Function-male) were assessed preoperatively (PQ), 3 to 4 months postileostomy closure (FQ1), and 12 to 18 months post-taTME [postoperative questionnaire 2 (FQ2)]. RESULTS: Among 83 patients who responded at all 3 time points, FIQL, Wexner, and COREFO significantly worsened postileostomy 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. International Prostate Symptom Score did not change relative to preoperative scores. For females, Female Sexual Function Index declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, International Index of Erectile Function 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 ).

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Perioperative outcomes for single-port robotic versus single-incision laparoscopic surgery: a comparative analysis in colorectal cancer surgery.

BACKGROUND: Single-incision laparoscopic surgery (SILS) may offer improved cosmesis, reduced postoperative pain and faster recovery than conventional platforms, but widespread implementation was limited by technical demands. A single-port robotic platform was recently introduced, with components that further enhance SILS benefits without the technical challenges. No study to date has compared the two platforms to validate benefits. Our goal was to compare outcomes of SP robotics and SILS in colorectal cancer (CRC). METHODS: A prospective cancer registry was reviewed for CRC patients undergoing curative resection through a SILS or SP robotic approach from 2010 to 2022. Patient and cancer demographics, intraoperative, and postoperative outcomes were compared in a 1:1 propensity score-matched cohort, adjusting for baseline characteristics. The main outcome measures were complications, operative time, and oncologic quality measures. RESULTS: Matching resulted 50 SP robotic and 50 SILS patients. Cohorts were well matched in all demographics, but SP robotic rectal cancer cases were significantly closer to the anorectal ring than SILS (1.8 cm vs. 3.4 cm, p = 0.018). SP robotic and SILS platforms had similar operative times. Intraoperative conversions was comparable, but more SILS cases required additional ports to be placed (p = 0.040). The intraoperative complications rate, complete total mesorectal excision rates, and lymph node yield were not statistically significantly different. There were no positive margins in either group. Postoperatively, groups had analogous day of return of bowel function, comparable morbidity, and discharge destination. There was no mortality in either group. The length of stay was significantly shorter with SP robotics than SILS (mean 4.135 vs. 5.282 days, median 4 (2-8) vs. 5 (2-14) days; p = 0.045). CONCLUSIONS: Single-port robotics provided high quality oncologic surgery, adding the technical benefits of robotics to clinical and cosmetic benefits of single-port surgery. There were comparable operative time, complication rates, and oncologic outcomes in CRC cases, with shorter hospital stays with SP robotics. This early data is encouraging for expansion SP robotic technology.

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.

One year follow-up of the colon cancer patient cohort treated with a novel miniaturized robotic-assisted surgery device (mRASD).

BACKGROUND: With the proven benefits of minimally invasive surgery, there is steady growth in robotic surgery use and interest in novel robotic platforms. A miniaturized Robotic-Assisted Surgery Device (mRASD) has been in clinical use under a multi-center, investigational device exemption (IDE) study for right and left colectomy. The goal of this work was to report the short-term and 12-month outcomes specifically for the cohort of colon cancer patients that underwent surgery using the mRASD. METHOD: From the IDE study that included both benign and malignant diseases, long-term follow-up was only conducted for patients with colon cancer. The main outcome measures were the oncologic quality metrics (Overall Survival, OS and Disease-free Survival, DFS). Secondary outcomes included incidence of intra-operative, device-related, and procedure-related adverse events. Frequency statistics were performed to assess the measures of central tendency and variability in short (within 30 days) and long-term (1-year) outcomes. RESULTS: Thirty total patients underwent a colectomy with mRASD; 17 (57%) were diagnosed with a malignancy and included in this analysis. The mean patient age was 59.9 ± 13.2 years. There were no intraoperative or device-related adverse events. In 100% of cases (n = 17), the primary dissection was completed and hemostasis maintained using the mRASD, and negative margins were achieved. At 30 days postoperatively, the major complication rate was 6%, and there was one unplanned reoperation for anastomotic leak. At one-year follow-up, the OS and DFS rates were 100 and 94%, respectively. In one patient, omental implants were discovered at the time of surgery, and the patient opted to not undergo additional therapy. CONCLUSIONS: The first experience with mRASD for colectomy in colon cancer demonstrated technical effectiveness and an acceptable surgical safety profile in line with other minimally invasive procedures. The study continues to monitor disease recurrence and survival outcomes in this cohort.

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.

Laparoscopic right colectomy: correct technique based on key anatomical principles.

Since the early1990s, laparoscopic right colon resections have been the most performed advanced laparoscopic procedures just after laparoscopic left colectomies and sigmoid resections. Indications for laparoscopic right colectomies are either benign or malignant diseases. Despite its many indications, a laparoscopic right or extended right colectomy is mostly performed for cancer of the caecum, the ascending colon, the hepatic flexure or the proximal transverse colon. Worldwide, colorectal cancer is the third most diagnosed cancer: an estimated 1,880,725 people were diagnosed with colorectal cancer in 2020, out of which 1,148,515 were colon cancer cases and 40% were located in the right colon. These figures make an oncologic sound surgery for right colon cancer of the utmost relevance. More recently, complete mesocolic excision has been advocated as the optimal choice in term of radicality, especially in node-positive patients with right colon cancer. Laparoscopic standard right colectomy and extended right colectomy with or without CME should be performed according to defined principles based on a close knowledge of key anatomical landmarks. This knowledge will allow to trace anatomical structures and drive instruments along the correct surgical planes and has its foundations in teachings from surgeons and scientists of past and present time.

Discordance in Total Mesorectal Excision Specimen Grading in a Prospective Phase 2 Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of Our Resections?

OBJECTIVES: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase 2 trial of transanal TME. BACKGROUND: Grading of TME specimens is based on the macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described. METHODS: A phase 2 prospective transanal TME trial was conducted from 2017 to 2022 across 11 North American centers with TME quality as the primary study endpoint. QC measures included (1) training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance before trial reporting. Cohen Kappa statistic was used to assess agreement in grading. RESULTS: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ = 0.35; 95% CI: 0.10-0.61; P < 0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases, respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre versus postreconciliation rates of complete or NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC-NC; N = 1) or major downgrade (NC/C-IC, N = 4) in 5 cases overall (5%). CONCLUSIONS: A 14% rate of major discordance was observed in TME grading between the site and central reviewers. The resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through a central review of TME photographs and reconciliation of major discordances is strongly recommended.

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.

International standardization and optimization group for intersphincteric resection (ISOG-ISR): modified Delphi consensus on anatomy, definition, indication, surgical technique, specimen description and functional outcome.

AIM: Intersphincteric resection (ISR) is an oncologically complex operation for very low-lying rectal cancers. Yet, definition, anatomical description, operative indications and operative approaches to ISR are not standardized. The aim of this study was to standardize the definition of ISR by reaching international consensus from the experts in the field. This standardization will allow meaningful comparison in the literature in the future. METHOD: A modified Delphi approach with three rounds of questionnaire was adopted. A total of 29 international experts from 11 countries were recruited for this study. Six domains with a total of 37 statements were examined, including anatomical definition; definition of intersphincteric dissection, intersphincteric resection (ISR) and ultra-low anterior resection (uLAR); indication for ISR; surgical technique of ISR; specimen description of ISR; and functional outcome assessment protocol. RESULTS: Three rounds of questionnaire were performed (response rate 100%, 89.6%, 89.6%). Agreement (≥80%) reached standardization on 36 statements. CONCLUSION: This study provides an international expert consensus-based definition and standardization of ISR. This is the first study standardizing terminology and definition of deep pelvis/anal canal anatomy from a surgical point of view. Intersphincteric dissection, ISR and uLAR were specifically defined for precise surgical description. Indication for ISR was determined by the rectal tumour's maximal radial infiltration (T stage) below the levator ani. A new surgical definition of T3isp was reached by consensus to define T3 low rectal tumours infiltrating the intersphincteric plane. A practical flowchart for surgical indication for uLAR/ISR/abdominoperineal resection was developed. A standardized ISR surgical technique and functional outcome assessment protocol was defined.

Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.

BACKGROUND: Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765). METHODS: 100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications. RESULTS: Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003). CONCLUSION: When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.

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.

Disease-free Survival and Local Recurrence for Laparoscopic Resection Compared With Open Resection of Stage II to III Rectal Cancer: Follow-up Results of the ACOSOG Z6051 Randomized Controlled Trial.

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.