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.

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.

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.

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.

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.

Same day discharge following elective, minimally invasive, colorectal surgery : A review of enhanced recovery protocols and early outcomes by the SAGES Colorectal Surgical Committee with recommendations regarding patient selection, remote monitoring, and successful implementation.

BACKGROUND: As enhanced recovery programs (ERPs) have continued to evolve, the length of hospitalization (LOS) following elective minimally invasive colorectal surgery has continued to decline. Further refinements in multimodal perioperative pain management strategies have resulted in reduced opioid consumption. The interest in ambulatory colectomy has dramatically accelerated during the COVID-19 pandemic. Severe restrictions in hospital capacity and fear of COVID transmission forced surgical teams to rethink strategies to further reduce length of inpatient stay. METHODS: Members of the SAGES Colorectal Surgery Committee began reviewing the emergence of SDD protocols and early publications for SDD in 2019. The authors met at regular intervals during 2020-2022 period reviewing SDD protocols, safe patient selection criteria, surrogates for postoperative monitoring, and early outcomes. RESULTS: Early experience with SDD protocols for elective, minimally invasive colorectal surgery suggests that SDD is feasible and safe in well-selected patients and procedures. SDD protocols are associated with reduced opioid use and prescribing. Patient perception and experience with SDD is favourable. For early adopters, SDD has been the natural evolution of well-developed ERPs. Like all ERPs, SDD begins in the office setting, identifying the correct patient and procedure, aligning goals and objectives, and the perioperative education of the patient and their supporting significant others. A thorough discussion with the patient regarding expected activity levels, oral intake, and pain control post operatively lays the foundation for a successful application of SDD programs. These observations may not apply to all patient populations, institutions, practice types, or within the scope of an existing ERP. However, if the underlying principles of SDD can be incorporated into an existing institutional ERP, it may further reduce the incidence of post operative ileus, prolonged LOS, and improve the effectiveness of oral analgesia for postoperative pain management and reduced opioid use and prescribing. CONCLUSIONS: The SAGES Colorectal Surgery Committee has performed a comprehensive review of the early experience with SDD. This manuscript summarizes SDD early results and considerations for safe and stepwise implementation of SDD with a specific focus on ERP evolution, patient selection, remote monitoring, and other relevant considerations based on hospital settings and surgical practices.

North American multicentre evaluation of a same-day discharge protocol for minimally invasive colorectal surgery using mHealth or telephone remote post-discharge monitoring.

BACKGROUND: Same-day discharge (SDD) after colectomy is feasible but requires effective post-discharge remote follow-up. Previous studies have used in-person home visits or a mobile health (mHealth) phone app, but the use of simple telephone calls for remote follow-up has not yet been studied. Therefore, the objective of this study was to compare outcomes after SDD for minimally invasive colectomy using mHealth or telephone remote post-discharge follow-up. METHODS: A prospective cohort study was undertaken at two university-affiliated colorectal referral institutions from 02/2020 to 05/2021. Adult patients without significant comorbidities undergoing elective minimally invasive colectomy. Patients were discharged on the day of surgery based on set criteria. Post-discharge remote follow-up was performed using a mHealth app at site 1 and scheduled telephone calls at site 2 up to postoperative day (POD) 7. The main outcome for this study was the success rate of SDD, defined as discharge on POD0 without emergency department (ED) visit or readmission within the first 3 days. RESULTS: A total of 105 patients were recruited (site 1, n = 70; site 2, n = 35). Overall, 75% of patients were discharged on POD0 (site 1 81% vs. site 2 63%, p = 0.038), of which only two patients required an ED visit within the first 3 days, leading to an overall success rate of 73% (site 1 80% vs. site 2 60%, p = 0.029). The incidence of 30-day complications (16% vs. 20%, p = 0.583), ED visits (11% vs. 11%, p = 1.00), and readmissions (9% vs. 14%, p = 0.367) were similar between the two sites. There was only one patient at each study site that went to the ED without instructions through remote follow-up. CONCLUSIONS: A high proportion of patients planned for SDD were discharged on POD0 with few patients requiring an early unplanned ED visit. These results were similar with an mHealth app or telephone calls for post-discharge remote follow-ups, suggesting that SDD is feasible regardless of the method of post-discharge remote follow-up.

The SAGES MASTERS program presents: the 10 seminal articles for the Laparoscopic Right Colectomy Pathway.

BACKGROUND: As one of the 12 clinical pathways of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Masters Program, the Colorectal Pathway intends to deliver didactic content organized along 3 levels of performance (competency, proficiency and mastery) each represented by an anchoring procedure (laparoscopic right colectomy, laparoscopic left/sigmoid colectomy, and intracorporeal anastomosis during minimally invasive (MIS) ileocecal or right colon resection). In this article, the SAGES Colorectal Task Force presents focused summaries of the top 10 seminal articles selected for laparoscopic right colectomy which surgeons should be familiar with. METHODS: Using a systematic literature search of Web of Science, the most cited articles on laparoscopic right colectomy were identified, reviewed, and ranked by the SAGES Colorectal Task Force and invited subject experts. Additional articles not identified in the literature search were included if deemed impactful by expert consensus. The top 10 ranked articles were then summarized, with emphasis on relevance and impact in the field, findings, strengths and limitations, and conclusions. RESULTS: The top 10 seminal articles selected for the laparoscopic right colectomy anchoring procedure include articles on surgical techniques for benign and malignant disease, with anatomical and video illustrations, comparative outcomes of laparoscopic vs open colectomy, variations in technique with impact on clinical outcomes, and assessment of the learning curve. CONCLUSIONS: The top 10 seminal articles selected for laparoscopic right colectomy illustrate the diversity both in content and format of the educational curriculum of the SAGES Masters Program to support practicing surgeon progression to mastery within the Colorectal Pathway.

Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection.

BACKGROUND: Indocyanine green fluoroscopy has been shown to improve anastomotic leak rates in early phase trials. OBJECTIVE: We hypothesized that the use of fluoroscopy to ensure anastomotic perfusion may decrease anastomotic leak after low anterior resection. DESIGN: We performed a 1:1 randomized controlled parallel study. Recruitment of 450 to 1000 patients was planned over 2 years. SETTINGS: This was a multicenter trial. PATIENTS: Included patients were those undergoing resection defined as anastomosis within 10 cm of the anal verge. INTERVENTION: Patients underwent standard evaluation of tissue perfusion versus standard in conjunction with perfusion evaluation using indocyanine green fluoroscopy. MAIN OUTCOME MEASURES: Primary outcome was anastomotic leak, with secondary outcomes of perfusion assessment and the rate of postoperative abscess requiring intervention. RESULTS: This study was concluded early because of decreasing accrual rates. A total of 25 centers recruited 347 patients, of whom 178 were randomly assigned to perfusion and 169 to standard. The groups had comparable tumor-specific and patient-specific demographics. Neoadjuvant chemoradiation was performed in 63.5% of perfusion and 65.7% of standard (p > 0.05). Mean level of anastomosis was 5.2 ± 3.1 cm in perfusion compared with 5.2 ± 3.3 cm in standard (p > 0.05). Sufficient visualization of perfusion was reported in 95.4% of patients in the perfusion group. Postoperative abscess requiring surgical management was reported in 5.7% of perfusion and 4.2% of standard (p = 0.75). Anastomotic leak was reported in 9.0% of perfusion compared with 9.6% of standard (p = 0.37). On multivariate regression analysis, there was no difference in anastomotic leak rates between perfusion and standard (OR = 0.845 (95% CI, 0.375-1.905); p = 0.34). LIMITATIONS: The predetermined sample size to adequately reduce the risk of type II error was not achieved. CONCLUSIONS: Successful visualization of perfusion can be achieved with indocyanine green fluoroscopy. However, no difference in anastomotic leak rates was observed between patients who underwent perfusion assessment versus standard surgical technique. In experienced hands, the addition of routine indocyanine green fluoroscopy to standard practice adds no evident clinical benefit. See Video Abstract at http://links.lww.com/DCR/B560. VALORACIN DE LA IRRIGACIN DE LADO IZQUIERDO/RESECCIN ANTERIOR BAJA PILAR III UN ESTUDIO ALEATORIZADO, CONTROLADO, PARALELO Y MULTICNTRICO QUE EVALA LOS RESULTADOS DE LA IRRIGACIN CON PINPOINT IMGENES DE FLUORESCENCIA CERCANA AL INFRARROJO EN LA RESECCIN ANTERIOR BAJA: ANTECEDENTES:Se ha demostrado que la fluoroscopia con verde de indocianina mejora las tasas de fuga anastomótica en ensayos en fases iniciales.OBJETIVO:Nuestra hipótesis es que la utilización de fluoroscopia para asegurar la irrigación anastomótica puede disminuir la fuga anastomótica luego de una resección anterior baja.DISEÑO:Realizamos un estudio paralelo, controlado, aleatorizado 1:1. Se planificó el reclutamiento de 450-1000 pacientes durante 2 años.AMBITO:Multicéntrico.PACIENTES:Pacientes sometidos a resección definida como una anastomosis dentro de los 10cm del margen anal.INTERVENCIÓN:Pacientes que se sometieron a la evaluación estándar de la irrigación tisular contra la estándar en conjunto con la valoración de la irrigación mediante fluoroscopia con verde indocianina.PRINCIPALES VARIABLES EVALUADAS:El principal resultado fue la fuga anastomótica, y los resultados secundarios fueron la evaluación de la perfusión y la tasa de absceso posoperatorio que requirió intervención.RESULTADOS:Este estudio se cerró anticipadamente debido a la disminución de las tasas de acumulación. Un total de 25 centros reclutaron a 347 pacientes, de los cuales 178 fueron, de manera aleatoria, asignados a perfusión y 169 a estándar. Los grupos tenían datos demográficos específicos del tumor y del paciente similares. Recibieron quimio-radioterapia neoadyuvante el 63,5% de la perfusión y el 65,7% del estándar (p> 0,05). La anastomosis estuvo en un nivel promedio de 5,2 + 3,1 cm en perfusión en comparación con 5,2 + 3,3 cm en estándar (p> 0,05). Se reportó una visualización suficiente de la perfusión en el 95,4% de los pacientes del grupo de perfusión. El absceso posoperatorio que requirió tratamiento quirúrgico fue de 5,7% de los perfusion y en el 4,2% del estándar (p = 0,75). Se informó fuga anastomótica en el 9,0% de la perfusión en comparación con el 9,6% del estándar (p = 0,37). En el análisis de regresión multivariante, no hubo diferencias en las tasas de fuga anastomótica entre la perfusión y el estándar (OR 0,845; IC del 95% (0,375; 1,905); p = 0,34).LIMITACIONES:No se logró el tamaño de muestra predeterminado para reducir satisfactoriamente el riesgo de error tipo II.CONCLUSIÓN:Se puede obtener una visualización adecuada de la perfusión con ICG-F. Sin embargo, no se observaron diferencias en las tasas de fuga anastomótica entre los pacientes que se sometieron a evaluación de la perfusión versus la técnica quirúrgica estándar. En manos expertas, agregar ICG-F a la rutina de la práctica estándar no agrega ningún beneficio clínico evidente. Consulte Video Resumen en http://links.lww.com/DCR/B560. (Traducción-Dr Juan Antonio Villanueva-Herrero).

Transanal total mesorectal excision (taTME) for rectal cancer: beyond the learning curve.

BACKGROUND: Transanal total mesorectal excision (taTME) is a surgical approach for low rectal cancer with a learning curve estimated at 40-50 cases. The experience among taTME surgeons beyond their learning curve is limited. METHODS: A retrospective analysis of all taTME cases performed for rectal cancer at two tertiary care hospitals from 2014 to 2019 was conducted. Transanal surgeons had previously performed > 50 taTME cases. Demographic, perioperative, and short-term outcomes were analyzed. RESULTS: Among 54 taTME patients, 74.1% were male and 27.8% had a BMI ≥ 30. Tumors were stage I (8), II (13), III (29), and IV (4). Complex cases included 4 local recurrences, 4 prior liver resections, and 2 with prior prostate cancer. Thirty tumors were located ≤ 6 cm from the anal verge. On staging MRI, 12 had a positive predicted circumferential radial margin (+CRM), and 4 had internal anal sphincter involvement (+IAS). Forty-seven patients received neoadjuvant therapy. A 2-team approach was used in 51 patients with laparoscopic (83.3%) or robotic (16.7%) abdominal assistance with a 9.2% conversion rate. Low anterior resection with sphincter salvage was achieved in 87% with 8 patients requiring intersphincteric resection. Anastomoses were hand-sewn in 57.4% and all patients were diverted. Median LOS was 5 days with a 42.6% 30-day morbidity rate and 3 postoperative mortalities (ARDS, pulmonary embolism and pseudomembranous colitis). Complete and near complete TME grade was achieved in 94.4% with a 3.7% rate of +CRM. At a median follow-up of 28 months, local and distant recurrence rates were 3.9% and 17.6%, respectively, with no cancer-related mortality. CONCLUSION: Indications for taTME at experienced centers have expanded to include complex reoperative cases, local recurrences, metastatic cancer, and tumors with threatened CRM or IAS with evidence of post-treatment tumor regression. In the latter cases, taTME achieves good short-term outcomes and may facilitate R0 resection.

Learning Transanal Total Mesorectal Excision.

A dynamic evolution is occurring in transanal surgery. Transanal techniques began with intraluminal surgical removal of rectal masses and have progressed to transanal total mesorectal excision (taTME) for rectal cancer. TaTME was first performed in 2009 by Sylla, Rattner, Delgado, and Lacy. This article documents the training pathway followed by pioneers in the taTME technique as well as consensus reports outlining the process of learning the taTME technique. A literature search was performed for taTME training, learning, and technique. Key elements in learning the taTME technique include appropriate indications, cadaver training, and outcomes reporting such as participating in a taTME registry. Consensus reports also agree on the following facets associated with improved outcomes: (1) appropriate case selection of mid and low rectal cancers, (2) prerequisite completion of an accredited training program in laparoscopic colorectal surgery and prior experience in transanal endoscopic surgery, (3) a two-team taTME approach from above and below is ideal, and (4) higher rectal cancer volume surgical practice. The unifying international recommendation for surgeons interested in learning the taTME technique conveys the following message: taTME is an advanced and complex technique that requires dedicated training and experience in TME surgery.

Racial and Socioeconomic Treatment Disparities in Adolescents and Young Adults with Stage II-III Rectal Cancer.

INTRODUCTION: Stage II-III rectal cancer requires multidisciplinary cancer care, and adolescents and young adults (AYA, ages 15-39 years) often do not receive optimal cancer therapy. METHODS: Overall, 3295 AYAs with clinical stage II-III rectal cancer were identified in the National Cancer Database. Factors associated with the receipt of adjuvant and surgical therapies, as well as overall survival (OS), were examined. RESULTS: The majority of patients were non-Hispanic White (72.0 %), male (57.5 %), and without comorbidities (93.8 %). A greater proportion of Black and Hispanic patients did not receive radiation (24.5 and 27.1 %, respectively, vs. 16.5 % for non-Hispanic White patients), surgery (22.4 % and 21.6 vs. 12.3 %), or chemotherapy (21.5 % and 24.1 vs. 14.7 %) compared with non-Hispanic White patients (all p < 0.05). After controlling for competing factors, Black (odds ratio [OR] 0.7, 95 % confidence interval [CI] 0.5-0.9) and Hispanic patients (OR 0.6, 95 % CI 0.4-0.9) were less likely to receive neoadjuvant chemoradiation compared with non-Hispanic White patients. Females, the uninsured, and those treated at a community cancer center were also less likely to receive neoadjuvant therapy. Having government insurance (OR 0.22, 95 % CI 010-0.49) was a predictor for not receiving surgery. Although 5-year OS was lower (p < 0.05) in Black (59.8 %) and Hispanic patients (65.9 %) compared with non-Hispanic White patients (74.9 %), on multivariate analysis race did not impact mortality. Not having surgery (hazard ratio [HR] 7.1, 95 % CI 2.8-18.2) had the greatest influence on mortality, followed by poorly differentiated histology (HR 3.0, 95 % CI 1.3-6.5), nodal positivity (HR 2.6, 95 % CI 1.9-3.6), no chemotherapy (HR 1.9, 95 % CI 1.03-3.6), no insurance (HR 1.7, 95 % CI 1.1-2.7), and male sex (HR 1.5, 95 % CI 1.1-2.0). CONCLUSION: There are racial and socioeconomic disparities in the treatment of stage II-III rectal cancer in AYAs, many of which impact OS. Interventions that can address and mitigate these differences may lead to improvements in OS for some patients.

Transanal total mesorectal excision (taTME) for rectal cancer: a training pathway.

BACKGROUND: With increasing interest in natural orifice surgery, there has been a dramatic evolution of transanal and endoluminal surgical techniques. These techniques began with transanal endoluminal surgical removal of rectal masses and have progressed to transanal radical proctectomy for rectal cancer. The first transanal total mesorectal excision (taTME) was performed in 2009 by Sylla, Rattner, Delgado, and Lacy. The improved visibility and working space associated with the taTME technique is intriguing. This video manuscript outlines the training pathway followed by pioneers in the taTME technique, the process of implementation into clinical practice, and initial case report. METHODS: A double board-certified colorectal surgeon with expertise in rectal cancer, minimally invasive total mesorectal excision, transanal endoscopic surgery (TES), and intersphincteric dissection, underwent taTME training in male cadaver models. Institutional review board (IRB) approval for a phase I clinical trial was achieved. The entire operative team including surgeons, nurses, and operative staff underwent taTME cadaver training the day prior to the first clinical case. The case was proctored by an expert in taTME. RESULTS: A 66-year-old male with uT3N1M0 rectal cancer located in the posterior distal rectum, underwent taTME with laparoscopic abdominal assistance, hand sewn coloanal anastomosis, and diverting loop ileostomy. The majority of the TME was performed transanally with laparoscopic assistance for exposure, splenic flexure mobilization, and high ligation of the vascular pedicles. Operative time was 359 min. There were no intraoperative complications. Pathology revealed a ypT2N1 moderately differentiated invasive adenocarcinoma, grade I TME, 1 cm circumferential radial margin, and 2/13 positive lymph nodes. CONCLUSION: Implementation of taTME into practice can be achieved by surgeons with expertise in minimally invasive TME, TES, pre-clinical taTME training in cadavers, case observation, proctoring, and ongoing mentorship. IRB peer review process and participation in a clinical registry are additional measures that should be employed.

Ongoing evolution of practice gaps in gastrointestinal and endoscopic surgery: 2014 report from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Continuing Education Committee.

BACKGROUND: In an effort to fulfill the charge to develop and maintain a comprehensive educational program to serve the members of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), the SAGES Continuing Education Committee reports a summary of findings related to the evaluation of the 2014 SAGES annual meeting. METHODS: All attendees to the 2014 annual meeting had the opportunity to complete an immediate post-meeting questionnaire as part of their continuing medical education (CME) certification, and identify up to two learning themes, answer questions related to potential practice change items based on these learning themes, and complete a needs assessment for relevant learning topics for future meetings. In addition, participants in the postgraduate and hands-on courses were asked to complete questions about case volume and comfort level related to procedures/topics in those courses. All respondents to this initial survey were sent a 3-month follow-up questionnaire in which they were asked how successful they had been in the implementation of the targeted practice changes and what, if any, barriers were encountered. Descriptive statistical analysis of de-identified data was undertaken. SAGES University attendees respond to a post-test and post-activity evaluation. RESULTS: Response rates were 43 and 31 % for CME-eligible attendees/respondents for the immediate post-meeting and 3-month follow-up questionnaires, respectively. Top learning themes for respondents were foregut, hernia, bariatric, and colorectal. Improving minimally invasive surgical (MIS) technique and managing complications related to MIS procedures were top intended practice changes. Partial implementation was common with top barriers including lack of resources and lack of time. Desired topics for future meetings included management of complications, enhanced recovery after surgery, introduction of new procedures into clinical practice, and re-operative surgery. CONCLUSIONS: The SAGES 2014 annual meeting analysis provides insight into the educational needs among respondents, which is meaningful information for planning future meeting educational content.

The price of decreased mortality in the operative management of diverticulitis.

BACKGROUND: Healthcare costs in the United States are increasing. It is thought that as cost increases, outcomes should improve. The aim of this study was to analyze patient charges and mortality in the operative management of diverticulitis over time. METHODS: A retrospective analysis of the Nationwide Inpatient Sample database was performed. Adults with diverticulitis who underwent laparoscopic or open partial colectomy were identified by ICD-9 codes. Multivariate analyses examined in-hospital mortality and total charges. Results were adjusted for age, race, gender, Charlson comorbidity index, surgical approach (open vs. laparoscopic), and insurance status. RESULTS: From 1998 to 2010, 148,348 patients had a partial colectomy for diverticulitis. After adjusting for other covariates and inflation, the average charge of hospitalization per admission increased by $34,057 from 1998 to 2010. In the same observation period, adjusted in-hospital mortality decreased significantly by 2005 compared to 1998 (p < 0.001, OR 0.77, 95% CI 0.68-0.88) and remained unchanged for the remainder of the study period. Additionally, laparoscopic management was associated with lower rate of charge increase compared to open management (p < 0.001), such that charges are currently higher for open management than laparoscopic. CONCLUSION: In-hospital mortality following partial colectomy for diverticulitis has improved over time, most dramatically after 2005. With decreasing mortality, an increase in hospital charges is observed on an annual basis. However, while mortality reached a plateau after 2005, overall charges continue to rise.

Foramen of Winslow hernia: a minimally invasive approach.

Hernias through the foramen of Winslow comprise 8 % of all internal hernias and the majority contain incarcerated bowel. Clinical signs are often non-specific and delay in diagnosis associated with a mortality rate that approaches 50 %. Management is urgent surgical reduction with bowel decompression and resection of devitalized bowel. A foramen of Winslow hernia (FWH) has traditionally been managed via an exploratory laparotomy incision and the vast majority of cases describe an open approach. We describe a minimally invasive approach to the management of an incarcerated FWH requiring decompression and bowel resection.

Variation of outcome and charges in operative management for diverticulitis.

BACKGROUND: Outcomes after surgery for diverticulitis are of continued interest to improve quality of care. The aim of this study was to assess variations in mortality, length of stay, and patient charges between geographic regions of the United States. METHODS: A retrospective analysis of the Nationwide Inpatient Sample database was performed. Adults with diverticulitis who underwent laparoscopic or open segmental colectomy were identified using ICD-9 codes. Subset analyses were performed by state and then compared. Outcomes included mortality, length of stay (LOS), and total charges. Results were adjusted for age, race, gender, findings of peritonitis, stoma placement, Charlson comorbidity index, and insurance status on multivariate analysis. RESULTS: 148,874 patients underwent segmental colectomy for diverticulitis from 1998 to 2010. Using California as the comparison state and after adjusting for covariates, in-hospital mortality was significantly higher in the State of New York (OR 1.32; 95 % CI 1.13-1.55; P < 0.05) and Mississippi (OR 2.84; 95 % CI 1.24-6.51, P < 0.02). Wisconsin had a significant lower mortality rate (OR 0.74; 95 % CI 0.59-0.94, P < 0.01). LOS was 1.4 days longer in New York and 0.54 days shorter in Wisconsin than in California (P < 0.01). Patients with age >40 years, findings of peritonitis, and without private insurance had higher in-hospital mortality and longer length of stay. Average hospital charges differed dramatically between the states in the observation period. The highest hospital charges occurred in California, Nebraska, and Nevada while lowest occurred in Maryland, Wisconsin and Utah. CONCLUSIONS: Patients who undergo surgical treatment for diverticulitis in the United States have high geographic variation in mortality, LOS, and hospital charges despite adjusting for demographic and socioeconomic factors. Further analysis should be performed to identify the causes of outlier regions, with the goal of improving and standardizing best practices.

Significant reduction in the incidence of small bowel obstruction and ventral hernia after laparoscopic compared to open segmental colorectal resection.

PURPOSE: The aim of this study is to assess the incidence of incisional ventral hernia and small bowel obstruction following laparoscopic and open colorectal resection. METHODS: A retrospective review was performed of a large database comprising 13 hospitals, serving 3.6 million patients in Southern California. Patients 18 years and older undergoing elective colorectal resection over a 3-year period were included. The crude incidence rates were calculated, and relative risks of ventral hernia and small bowel obstruction were determined using multivariable proportional hazard modeling. RESULTS: Four thousand six hundred and thirteen patients underwent 4765 colorectal resections between August 2008 and August 2011. Fifty-nine percent of the cases were performed laparoscopically; the median age was 63 years, and 49% were males. Colorectal carcinoma (45%) and diverticulitis (18%) were the most common indications for surgery. The median follow-up was 2.4 years. Kaplan-Meier estimates of ventral hernia at 1, 2, and 3 years among the open cohort were significantly higher at 10.1, 17.0, and 20.5%, compared to 5.7, 8.7, and 10.8% in the laparoscopic cohort (p < 0.001). Similarly, small bowel obstruction was higher in the open compared to the laparoscopic group (open 10.4, 15.0, and 18.3% vs. laparoscopic 2.7, 4.4, and 5.5%, p < 0.001). Patients undergoing laparoscopic colorectal resection were less likely to develop ventral hernia [adjusted hazard ratio (AHR) 0.64 (95% CI 0.52, 0.80); p < 0.0001] and small bowel obstruction [AHR 0.41 (95% CI 0.31, 0.54); p < 0.0001]. CONCLUSIONS: The incidence of incisional ventral hernia and small bowel obstruction is significantly reduced in patients who undergo laparoscopic compared to open colorectal resection.

eTAMIS: endoscopic visualization for transanal minimally invasive surgery.

BACKGROUND: Transanal endoscopic microsurgical (TEM) resection is associated with improved outcomes compared to transanal excision of rectal lesions. However, TEM equipment requires additional operative setup time, and tumor location dictates patient positioning. In 2010, Drs. Attallah, Albert, and Larach developed an alternative technique, transanal minimally invasive surgery (TAMIS). Herein, we describe our novel experience using endoscopic visualization to perform TAMIS (eTAMIS) to remove a large rectal polyp. METHODS: This is a technical note describing a new surgical technique, eTAMIS. The technique is performed with the Gelpoint Path TAMIS platform (Applied Medical, Rancho Santa Margarita, CA) and a standard single-channel endoscope for visualization. Patient demographics, operative data, and pathologic data were recorded. RESULTS: eTAMIS was initially performed in a 50-year-old woman with an endoscopically defiant rectal mass discovered on routine screening colonoscopy. The lesion was a tubulovillous adenoma, 10 cm from the anal verge, anterior, and occupied 15-20 % of the circumference. The rectal mass was removed by eTAMIS. The operative time was 101 minutes, and the patient was discharged within 24 h without event. Final pathology revealed a focus of well-differentiated rectal adenocarcinoma with focal invasion into the muscularis mucosa (Haggit level 0, pTis) arising in the head of a pedunculated tubulovillous adenoma. At 1-year follow-up endoscopy, the patient had no evidence of recurrent mass or polyp. CONCLUSIONS: This is the first technical report describing endoscopic visualization for TAMIS. Endoscopic visualization facilitates intraluminal articulation and lens cleaning while minimizing extraluminal instrument collisions. eTAMIS is a practical and logical evolution of the visual approach to natural orifice transluminal endoscopic surgery and laparoendoscopic surgery.

TAMIS-assisted laparoscopic low anterior resection with total mesorectal excision in a cadaveric series.

BACKGROUND: To demonstrate the feasibility of an innovative technique for the surgical management of rectal cancer, we performed transanal minimally invasive surgery assisted low anterior resection with total mesorectal excision (TAMIS-assisted LAR with TME) in a cadaver model. Transanal LAR via natural orifice transluminal endoscopic surgery has been reported in cadaveric series using rigid transanal platforms. This procedure has not been described using a combination of a single incision laparoscopy and TAMIS transanal endoscopic platform. We describe the first cadaveric series of TAMIS-assisted LAR with TME. METHODS: TAMIS-assisted LAR with TME was successfully performed in five fresh human cadavers. The procedure was performed using the mini-Gelpoint single incision platform and the Gelpoint Path TAMIS platform (Applied Medical, Rancho Santa Margarita, CA). The variables recorded were age, body mass index (BMI), operative time, complications, and specimen length. The grade of the TME was determined by evaluation of the specimen by photo documentation by a gastrointestinal pathologist. RESULTS: All cadavers were male with a mean age of 71 ± 8 years and mean BMI of 28 ± 3 kg/m(2). The mean operative time was 200 ± 55 min (range 128-249 min). The quality of the TME was grade I (complete) with intact mesorectum in all five cases. The mean specimen length was 36.8 ± 3.4 cm. CONCLUSIONS: TAMIS-assisted LAR with TME was feasible. A high-quality TME can be achieved using this innovative technique. Transanal endoscopic total mesorectal dissection may revolutionize the surgical management of rectal cancer. However, multicenter clinical trials are needed to further evaluate the oncologic safety and surgical outcomes of transanal endoscopic TME using various platforms before widespread application of this new technique.