Expert assessment of infiltration depth and recommendation of endoscopic resection technique in early Barrett cancer.

BACKGROUND: Early Barrett cancer can be curatively treated by endoscopic resection. The choice of the resection technique, however-endoscopic mucosal resection (EMR) or submucosal dissection (ESD)-largely depends on the assumed infiltration depth as judged by the endoscopist. However, the accuracy of endoscopic diagnosis of the degree of cancer infiltration is not known. METHODS: Three to four high-quality images (both in overview and close-up) from 202 of early Barrett esophagus cancer cases (82% men, mean age 66.9 years) were selected from our endoscopy database (73.3% stage T1a and 26.7% in stage T1b). Images were shown to 9 Barrett esophagus experts, with patients' clinical data (age, sex, Barrett esophagus length) and biopsy results. The experts were asked to predict infiltration depth (T1b vs. T1a), and to suggest the appropriate endoscopic resection technique (EMR or ESD, or surgery). Interobserver variability (kappa values) was also determined for these parameters. RESULTS: Overall positive (PPV) and negative predictive values (NPV) to diagnose T1b versus T1a infiltration were 40.7% (95% CI: 36.7, 44.8) and 79.8% (95% CI: 77.5, 81.9), respectively; kappa value was 0.41. Paris classification (kappa 0.51) and suggested treatment also varied between experts. In a post hoc analysis, only the correlation between lesions classified as invisible or flat according to the Paris classification (IIB; 25% of all cases) and the suggested resection technique was better: In this subgroup, EMR was recommended in >80% of cases, with a high complete (basal R0) resection rate (mean of 88.1%). CONCLUSIONS: Precise endoscopic distinction between mucosal and submucosal involvement of Barrett esophagus cancer by experts as a basis for choosing the resection technique has limited predictive values and high interobserver variability. It seems that mainly invisible/flat lesions may result in good resection outcomes when treated by EMR, but this stratification strategy has to be assessed in further studies.

Transparency-enhancing technology allows the three-dimensional assessment of esophageal carcinoma obtained by endoscopic submucosal dissection.

BACKGROUND: Although much progress has been made in diagnosis of carcinomas, no established methods have been confirmed to elucidate their morphological features. METHODS: Three-dimensional structure of esophageal carcinomas was assessed using transparency-enhancing technology. Endoscopically resected esophageal squamous cell carcinoma was fluorescently stained, optically cleared using a transparency-enhancing reagent called LUCID, and visualized using laser scanning microscopy. The resulting microscope images were converted to virtual HE images for observation using ImageJ software. RESULTS: Microscopic observation and image editing enabled three-dimensional image reconstruction and conversion to virtual HE images. The structure of abnormal blood vessels in esophageal carcinoma recognized by endoscopy could be observed in the 3 dimensions. Squamous cell carcinoma and normal squamous epithelium could be distinguished in the virtual HE images. CONCLUSIONS: The results suggested that transparency-enhancing technology and virtual HE images may be feasible for clinical application and represent a novel histopathological method for evaluating endoscopically resected specimens.

Novel quantitative assessment indicators for efficiency and precision of endoscopic submucosal dissection in animal training models by analyzing an electrical surgical unit.

OBJECTIVES: Although endoscopic submucosal dissection (ESD) training is important, quantitative assessments have not been established. This study aimed to explore a novel quantitative assessment system by analyzing an electrical surgical unit (ESU). METHODS: This was an ex vivo study. Step one: to identify the novel efficiency indicators, 20 endoscopists performed one ESD each, and we analyzed correlations between their resection speed and electrical status. Step two: to identify the novel precision indicators, three experts and three novices performed one ESD each, and we compared the stability of the electrical status. Step three: three novices in step two performed 19 additional ESDs, and we analyzed the learning curve using novel indicators. RESULTS: Step one: the percentage of total activation time (AT) of ESU in the procedure time (ß coefficient, 0.80; P < 0.01) and AT required for submucosal dissection (ß coefficient, -0.57; P < 0.01) were significantly correlated with the resection speed. Step two: coefficient of variation of the AT per one pulse (0.16 [range, 0.13-0.17] vs. 0.26 [range, 0.20-0.41], P = 0.049) and coefficient of variation of the peak electric power per pulse during mucosal incision (0.14 [range, 0.080-0.15] vs. 0.25 [range, 0.24-0.28], P = 0.049) were significantly lower in the experts than in the novices. Regarding the learning curve, the percentage of total AT of ESU in the procedure time and AT required for submucosal dissection had a trend of improvement. CONCLUSION: Novel indicators identified by analyzing ESU enable quantitative assessment for endoscopist's skill.

Endoscopic Submucosal Dissection (ESD) Offers a Safer and More Cost-effective Alternative to Transanal Endoscopic Microsurgery (TEM): An International Collaborative Study.

BACKGROUND: Endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM) are minimally invasive procedures that treat early rectal cancer (ERC). Both are effective treatments, yet there are very few studies comparing them. The aim of our study was to identify ideal candidates for each procedure. MATERIALS AND METHODS: Between January 2016 and November 2019, 204 ERC patients were managed with either ESD (n=101) or TEM (n=103) at 7 international centers. Data analyzed included clinical success, tumor characteristics, procedure info, and recurrence rates. RESULTS: Median tumor size was 40 mm±23.9 in the ESD group and 56 mm±27.9 in the TEM group, significantly larger in the latter ( P <0.00001). Average procedure time was 131.5±67.9 minutes in ESD group and 104.9±28.4 minutes in TEM group ( P =0.000347). Average hospital stay was 3.3±2.6 days in the ESD group and 4.7±0.7 days in the TEM group ( P <0.00001). Adverse event rate was 6.8% in the ESD group and 24% in the TEM group. There were no significant difference in the rate of en bloc resection, technical success, tumor location, necessity of additional procedures, and tumor recurrence rates. CONCLUSION: Compared with TEM, ESD is a safer procedure with shorter hospital stay and should be offered for patients who have ERC.

Does completing advanced endoscopy fellowship improve outcomes after endoscopic mucosal resection?

BACKGROUND: It was reported that about 60% of the physicians in the USA believed that their Gastroenterology fellowship poorly prepared them for large polyp resection. The aim of this study was to compare endoscopic mucosal resection (EMR) efficacy and complication rates between skilled general gastroenterologists who perform high volume of EMR and advanced endoscopists. METHODS: We identified 140 patients with documented large colonic polyps treated by 4 providers using EMR technique at Carilion Clinic, in Roanoke, Virginia, USA between 01/01/2014-12/31/2017, with follow-up through 10-2018. Information on demographics, clinical and pathological features of high-risk polyps (i.e., size, histology, site, and degree of dysplasia), timing of surveillance endoscopies, tools used during resection, and skills of performing endoscopist's were extracted. The cumulative risks of polyp recurrence after first resection using EMR technique were estimated using Kaplan-Meier curves. RESULTS: One hundred and forty patients were identified (mean age, 64.1±11.2 years; 47.1% males). Fifty-five polyps (39.3%) were removed by 2 skilled gastroenterologists and 85 (60.7%) were removed by advanced endoscopists. Most of the polyps resected were located in the right colon (63.6%) and roughly half of the polyps were removed in piecemeal fashion. At follow-up endoscopy, the advanced endoscopy group had lower polyp recurrence rates. The median recurrence after polypectomy was significantly different between the groups (0.88 and 1.03 years for skilled gastroenterologists who did not complete and completed EMR hands-on workshops; respectively vs. 3.99 years for the advanced endoscopist who did not complete EMR hands-on workshop, P=0.03). CONCLUSIONS: There is a need for additional EMR training since polyp recurrence was significantly different between the groups despite high rates of piecemeal resection in the advanced endoscopy groups.

Is Endoscopic Submucosal Dissection for Colorectal Lesions Performed in the Endoscopy Suite Safe and Cost Saving?

BACKGROUND: We aimed to compare the outcomes and the cost differences of endoscopic submucosal dissection (ESD) procedures in the endoscopy suite (ES) versus the operating room (OR). MATERIALS AND METHODS: The procedures in the OR were compared with procedures performed in the ES for demographics, lesion characteristics, procedure outcome, and procedure charges. The study included 163 procedures in the ES and 73 in the OR. RESULTS: Both were similar in age, sex, body mass index, and intraprocedural and postoperative 30-day (late) complications. ES cases had significantly greater polyp size, were more commonly right-sided polyps, and had shorter hospital stays, with similar en bloc and margin-negative resection rates. The overall cost ratio of ESD procedures in ES to OR was 0.47 ( P <0.001). CONCLUSIONS: Colorectal ESD procedures performed in the ES have similar efficacy and safety as those in the OR. Procedures performed in the ES were associated with a shorter length of stay and significant periprocedural cost savings.

Endoscopic submucosal dissection or piecemeal endoscopic mucosal resection for large superficial colorectal lesions: A cost effectiveness study.

BACKGROUND AND AIMS: Endoscopic management is preferred to surgical management for large superficial colorectal lesions. However, the optimal endoscopic resection strategy (piecemeal endoscopic mucosal resection [pEMR] or endoscopic submucosal dissection [ESD]) is still debated from an economical point of view. To date, in France, there is no Health Insurance reimbursement rate for the hospital stays related to ESD. We searched to estimate the global cost of colorectal ESD and to define the most cost-effectiveness endoscopic strategy. METHODS: A model was created to compare the cost-effectiveness of ESD and pEMR according to optical diagnosis (Japan NBI Expert Team [JNET], laterally spreading tumour [LST], CONECCT). We distinguished three groups from the same multicentre ESD cohort and compared the medical and economic outcomes: real-life ESD data (Universal-ESD or U-ESD) compared to modelled selective ESD (S-ESD JNET; S-ESD LST; S-ESD CONECCT) and exclusive pEMR strategies (Universal-EMR or U-EMR). RESULTS: The en-bloc, R0, and curative resection rates were 97.5%, 86.5%, and 82.6%, respectively in the real life French ESD cohort of 833 colorectal lesions. U-ESD was the least-expensive strategy, with a global cost of 2,858,048.17 €, i.e. 3,431.03 €/patient and was also the most effective strategy because it avoided 774 surgeries, which was more than any other strategy. It outperformed S-ESD CONNECT (global cost = 2,951,411.44 €, and 3,543.11 €/patient, 765 surgeries avoided, S-ESD LST (global cost = 3,055,951.53 €, and 3,668.61 €/patient, 749 surgeries avoided), and S-ESD JNET (global cost = 3,547,426.97 € and 4,258.62 €/patient, 704 surgeries avoided) and U-EMR (global cost = 4,060,547.62 € and 4,874.61 €/patient, 620 surgeries avoided). Even though a model which optimized pEMR results (0% technical failure, 0% primary surgery), U-EMR strategy remained the most expansive strategy and the one that avoided the least surgeries. CONCLUSION: ESD for all LSTs upper than 20 mm is more cost-effective than pEMR, and S-ESD.

Cold versus hot endoscopic mucosal resection for large sessile colon polyps: a cost-effectiveness analysis.

BACKGROUND : For large sessile colorectal polyps (LSCPs), endoscopic mucosal resection without diathermy ("cold endoscopic mucosal resection [EMR]") is gaining popularity because of its safety advantages over conventional EMR ("hot EMR"). Polyp recurrence rates have been reported to be higher with cold EMR. Considering these differences, we performed a cost-effectiveness analysis of these two techniques. METHODS : A decision analysis model was constructed for EMR of an LSCP. The decision tree incorporated the EMR method, clip use, procedural mortality, adverse events and their management, and polyp recurrence. Outcomes included days of lost productivity and marginal cost difference. Adverse event and recurrence rates were extracted from the existing literature, giving emphasis to recent systematic reviews and randomized controlled trials. RESULTS : Through 30 months of follow-up, the average cost of removing an LSCP by cold EMR was US$5213, as compared to $6168 by hot EMR, yielding a $955 cost difference (95 % confidence interval $903-$1006). Average days of lost productivity were 6.2 days for cold EMR and 6.3 days for hot EMR. This cost advantage remained over several analyses accounting for variations in recurrence rates and clip closure strategies. Clip cost and LSCP recurrence rate had the greatest and the least impacts on the marginal cost difference, respectively. CONCLUSION : Cold EMR is the dominant strategy over hot EMR, with lower cost and fewer days of lost productivity. In theory, a complete transition to cold EMR for LSCPs in the USA could result in an annual cost saving approaching US$7 million to Medicare beneficiaries.

Cost-effectiveness analysis of endoscopic resection for colorectal laterally spreading tumors: Endoscopic submucosal dissection versus piecemeal endoscopic mucosal resection.

OBJECTIVES: The cost-effectiveness of endoscopic submucosal dissection (ESD) and piecemeal endoscopic mucosal resection (pEMR) for colorectal laterally spreading tumors (LSTs) remains unclear. We examined the cost-effectiveness of these procedures for cases of colon/rectal LST-non-granular-type ≥2 cm and LST-granular-mixed-type ≥3 cm. METHODS: We performed a simulation model analysis using parameters based on clinical data from the National Cancer Center Hospital, Tokyo, and previous literature. The number of recurrences and surgeries and the required costs for 5 years following ESD and pEMR were assessed. Japanese cost data were used in the base-case analysis, and probabilistic sensitivity analysis (PSA) was performed. The Swedish cost data were used in the scenario analysis. RESULTS: Endoscopic submucosal dissection yielded a considerably lower number of recurrences and surgeries but required a higher cost than pEMR. The recurrence rates following ESD and pEMR were 0.9-1.3% and 21.1-25.9%, respectively. The incremental cost-effectiveness ratios for an avoided recurrence and surgery for ESD against pEMR were 376,796-476,496 JPY (3575-4521 USD) and 7,335,436-8,187,476 JPY (69,604-77,689 USD), respectively. PSA demonstrated that the probability of ESD being chosen as a more cost-effective option than pEMR was >50% at willingness-to-pay values of ≥400,000-500,000 JPY (3795-4744 USD) for avoiding a recurrence and ≥9,500,000-10,500,000 JPY (90,143-99,631 USD) for avoiding a surgery. In the scenario analysis, the required cost was also lower for ESD. CONCLUSIONS: Our findings suggest potentially favorable cost-effectiveness of ESD, depending on cost settings and the willingness-to-pay value for avoiding recurrence/surgery.

The Answer to "When to Clip" After Colorectal Endoscopic Mucosal Resection Based on a Cost-Effectiveness Analysis.

INTRODUCTION: Delayed bleeding (DB) is the most common major complication of endoscopic mucosal resection (EMR). Two randomized clinical trials recently demonstrated that clip closure after EMR of large nonpedunculated colorectal polyps (LNPCPs) reduces the risk of DB. We analyzed the cost-effectiveness of this prophylactic measure. METHODS: EMRs of LNCPCPs were consecutively registered in the ongoing prospective multicenter database of the Spanish EMR Group from May 2013 until July 2017. Patients were classified according to the Spanish Endoscopy Society EMR group (GSEED-RE2) DB risk score. Cost-effectiveness analysis was performed for both Spanish and US economic contexts. The average incremental cost-effectiveness ratio (ICER) thresholds were set at 54,000 € or $100,000 per quality-adjusted life year, respectively. RESULTS: We registered 2,263 EMRs in 2,130 patients. Applying their respective DB relative risk reductions after clip closure (51% and 59%), the DB rate decreased from 4.5% to 2.2% in the total cohort and from 13.7% to 5.7% in the high risk of the DB GSEED-RE2 subgroup. The ICERs for the universal clipping strategy in Spain and the United States, 469,706 € and $1,258,641, respectively, were not cost effective. By contrast, selective clipping in the high-risk of DB GSEED-RE2 subgroup was cost saving, with a negative ICER of -2,194 € in the Spanish context and cost effective with an ICER of $87,796 in the United States. DISCUSSION: Clip closure after EMR of large colorectal lesions is cost effective in patients with a high risk of bleeding. The GSEED-RE2 DB risk score may be a useful tool to identify that high-risk population.

Pathologic assessment of endoscopic resection specimens with superficial carcinoma of the esophagus: current practice and practical issues.

Endoscopic resection (ER) has become the first-line therapy for early esophageal cancer and offers a treatment alternative to surgery, owing to less morbidity and better quality of life. ER techniques include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). EMR is faster, simpler, and cheaper than ESD, but limited by its ability to resect lesions larger than 1.5 centimeters. Piecemeal EMR has limitations, including a high local recurrence rate and a suboptimal specimen for an accurate pathologic assessment. ESD, on the other hand, allows en bloc resections with negative (R0) margins, irrespective of lesion size, providing an excellent pathologic specimen, however, is technically challenging with a higher risk of complications. The evaluation of ER specimens in pathology varies slightly from institution to institution. Our review summarizes the current practices and issues in the pathologic assessment of esophageal ER specimens, which highlights the necessity of a systematic approach and standardization of both macroscopic and microscopic evaluation. There is a need for a comprehensive and standardized pathology report that will allow for uniform terminology for endoscopists, surgeons, and pathologists, which, in turn, will result in better treatment guidance.

Endoscopic Step Up: A Colon-Sparing Alternative to Colectomy to Improve Outcomes and Reduce Costs for Patients With Advanced Neoplastic Polyps.

BACKGROUND: The optimal strategy for colonic polyps not amenable to traditional endoscopic polypectomy is unknown. Endoscopic step up is a promising strategy for definitive treatment. OBJECTIVE: The purpose of this study was to determine whether endoscopic step up leads to improved outcomes and decreased costs compared with planned colectomy for endoscopically unresectable colon polyps. DESIGN: This was a retrospective review of a prospective database. SETTING: The study was conducted at a tertiary referral center. PATIENTS: Consecutive patients referred for endoscopically unresectable colon polyps 15 to 50 mm in size were included. INTERVENTIONS: Patients underwent planned colectomy or endoscopic step up at the surgeon's discretion. Endoscopic step up began with diagnostic colonoscopy in the operating room. If the polyp was amenable to endoscopic removal, endoscopic mucosal resection or endoscopic submucosal dissection was performed with progression to combined endoscopic-laparoscopic surgery or laparoscopic colectomy, as indicated. MAIN OUTCOME MEASURES: The primary outcome was 30-day adverse events. We also examined length of stay, hospital charges, insurer payments, and polyp recurrence. RESULTS: A total of 52 patients underwent planned colectomy (48 laparoscopic), and 38 underwent endoscopic step up (28 endoscopic mucosal resection, 2 endoscopic submucosal dissection, 6 combined endoscopic-laparoscopic surgery, and 2 colectomy). Compared with planned colectomy, endoscopic step-up patients had fewer complications (13% vs 33%; p = 0.03) and shorter length of stay (median, 0 vs 4 d; p < 0.001). There was 1 readmission in the endoscopic step-up group and 5 in the planned colectomy group. Endoscopic step-up patients had lower hospital costs ($4790 vs $13,004; p < 0.001) and insurer payments ($2431 vs $19,951; p < 0.001). One-year polyp recurrence-free survival was 84% (95% CI, 67%-93%) in endoscopic step-up patients. All of the recurrences were benign, <1 cm, and managed endoscopically. LIMITATIONS: The study was limited by its nonrandomized design and short follow-up. CONCLUSIONS: An endoscopic step-up approach to colon polyps is associated with less morbidity, decreased healthcare costs, and colon preservation in 95% of patients. Additional studies are needed to evaluate long-term quality of life and polyp recurrence in this group. See Video Abstract at http://links.lww.com/DCR/B188. ENDOSCOPIC STEP UP: UNA ALTERNATIVA A COLECTOMíA PARA PRESERVACIóN DE COLON CON LOS PROPóSITOS DE MEJORAR RESULTADOS Y REDUCIR COSTOS EN PACIENTES CON PóLIPOS NEOPLáSICOS AVANZADOS: Se desconoce la estrategia óptima para los pólipos de colon no susceptibles a la polipectomia endoscópica tradicional. Endoscopic Step Up es una estrategia prometedora para el tratamiento definitivo.Determinar si Endoscopic Step Up produce mejores resultados y menores costos en comparación con la colectomía programada para pólipos de colon endoscópicamente no resecables.Revisión retrospectiva de una base de datos prospectiva.Centro de referencia de tercer nivel.Pacientes consecutivos remitidos para pólipos de colon endoscópicamente irresecables de tamaño 15-50 mm.Los pacientes se sometieron a colectomía programada o Endoscópico Step Up a discreción del cirujano. Endoscopic Step Up comenzó con una colonoscopia diagnóstica en el quirófano. Si el pólipo era susceptible de extirpación endoscópica, la resección endoscópica de la mucosa o la disección submucosa endoscópica se realizaba con progresión a cirugía endoscópica-laparoscópica combinada o colectomía laparoscópica, según a cosnideraciones clínicas en el transoperatorio.El resultado primario fue los eventos adversos a 30 días. Duración de la estadía hospitalaria, los cargos hospitalarios, los pagos de las aseguradoras y la recurrencia de pólipos también fueron examinados.Un total de 52 pacientes se sometieron a colectomía programada (48 laparoscópicas) y 38 se sometieron a Endoscopic Step Up (28 resección endoscópica de la mucosa, 2 disección submucosa endoscópica, 6 cirugía endoscópica-laparoscópica combinada y 2 colectomía). En comparación con la colectomía programada los pacientes endoscópicos Step Up tuvieron menos complicaciones (13% versus 33%, p = 0.03) y una estadía hospitalaria más corta (mediana 0 versus 4 días, p <0.001). Hubo 1 reingreso hospitalario en el grupo Endoscopic Step Up y 5 en el grupo de colectomía programada. Los pacientes endoscópicos Step Up tuvieron costos hospitalarios más bajos ($ 4,790 versus $ 13,004, p <0,001) y pagos de la aseguradora ($ 2,431 versus $ 19,951, p <0,001). La supervivencia libre de recurrencia de pólipos a un año fue del 84% (IC 95% 67-93) en pacientes endoscópicos Step Up. Todas las recurrencias fueron benignas, <1 cm, y manejadas endoscópicamente.Diseño no aleatorizado y seguimiento corto.El abordaje endoscópico Step Up para pólipos de colon se asocia con menos morbilidad, disminución de los costos de atención médica y preservación del colon en el 95% de los pacientes. Se ocupan más estudios para evaluar la calidad de vida a largo plazo y la recurrencia de pólipos en este grupo. Consulte Video Resumen en http://links.lww.com/DCR/B188. (Traducción-Dr Adrián Ortega Robles).

Cost of Endoscopic Submucosal Dissection Versus Endoscopic Piecemeal Mucosal Resection in the Colorectum.

BACKGROUND: Few studies have compared the costs of colorectal endoscopic submucosal dissection (ESD) and endoscopic piecemeal mucosal resection (EPMR). AIMS: Here, we aimed to investigate the cost-effectiveness of these approaches by analyzing clinical outcomes and costs. METHODS: Data from patients undergoing colorectal ESD and EPMR were retrospectively reviewed. Clinical outcomes (procedure time, complete resection, and recurrence) were compared, and total direct costs (procedural and follow-up) were assessed. RESULTS: Data from 429 ESD and 115 EPMR patients were included in the analysis. The complete resection rate was significantly higher (83.9% vs. 32.2%, p < 0.001), recurrence rate was lower (0.5% vs. 7.1%, p < 0.001), procedure time was longer (55.4 ± 47.0 vs. 25.6 ± 32.7 min, p < 0.001), and total direct procedural costs at the initial resection were higher (1480.0 ± 728.0 vs. 729.8 ± 299.7 USD, p < 0.001) in the ESD group than in the EPMR group. The total number of surveillance endoscopies was higher in the EPMR group (1.7 ± 1.5 vs. 1.3 ± 1.1, p = 0.003). The cumulative total costs of ESD and EPMR were comparable at 3 and 2 years' follow-up in the adenoma and mucosal/superficial submucosal cancer subgroups, respectively. CONCLUSIONS: Colorectal ESD was associated with higher complete resection and lower recurrence rates. EPMR showed shorter procedure times and similar cumulative total direct costs. ESD or EPMR should be chosen based on both clinical outcomes and cost-effectiveness.

Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

Surgery Versus Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Large Polyps: Making Sense of When to Use Which Approach.

Endoscopic resection for large colorectal lesion is effective and cost-saving than surgery. Piecemeal resections are often effective if applied meticulously but endoscopic submucosal dissection (ESD) allows meritorious removal of large lesions in one piece. For rectal lesions, transanal endoscopic microsurgery or transanal minimally invasive surgery offers more radical transmural resection but ESD is also effective for removal of complex rectal lesions. Surgical resection with lymph node dissection is the gold standard for invasive cancer; however, the management of low-risk early-stage colorectal cancer is worth debating. Treatment selection for large colorectal lesions is discussed based on lesion factor and treatment outcomes.

Pre-operative assessment of internal mucosal rectal prolapse in internal hemorrhoids: technical details and results from a single institution.

BACKGROUND: The aim of the study was to assess safety and efficacy of pre-operative assessment for internal mucosal rectal prolapse (IMRP) in internal hemorrhoids, in order to achieve a tailored transanal stapled surgery. METHODS: All consecutive patients (January 2011 to December 2014; age 18-80 years), affected by prolapses with II-IV degrees hemorrhoids that underwent Longo procedure with EEA® Auto Suture stapler (Covidien) were included in the present study. RESULTS: A total of 100 consecutive patients (38 females) were enrolled in the study. Preoperative Visual Analogue Scale pain assessment was 7.33±2.68. The mean duration of the procedure was 34.1±17.8 min, and the median hospital stay was 2 days (range 2-6). No major complication occurred, including relapses of mucosal prolapse. Preoperative prolapse measurement with EEA® EEA® Auto Suture stapler (2.3±0.5 cm) was well correlated direct assessment (2.4±0.6, p<0.001), but a proportional bias was identified, with significant preoperative underestimation of IMRP, particularly for lesions larger than 3 cm (around 10% of actual extent). CONCLUSIONS: EEA® Auto Suture stapler seems to be safe and effective for a tailored approach to anorectal prolapse due to hemorrhoids. However, it reasonable that its actual impact may have been overestimated, beneficing of the repetitive, direct assessment of the operatory field guaranteed by preoperative IMRP measurement.

Effects of preoperative oral carbohydrates on patients undergoing ESD surgery under general anesthesia: A randomized control study.

BACKGROUND: Preoperative oral carbohydrate (POC) has been recommended as an important element of the enhanced recovery after surgery (ERAS) protocol, but its effect on patients undergoing endoscopic submucosal dissection (ESD) remains unclear. Our study aims to investigate the effects of POC for ESD surgery, with particular focus on perioperative well-being and gastric peristalsis. METHODS: A prospective, randomized, and controlled study of patients undergoing ESD was conducted. Seventy-three patients were assigned to 2 groups: experiment (36 patients) and control (37 patients). The experiment group received oral carbohydrate solution 710 mL the night before and 355 mL 2 hours prior to operation. The control group fasted for 10 hours prior to operation. Gastric empty assessment, peristaltic score, and operation score were measured. In addition, visual analogue scale (VAS) scores for 6 parameters (thirst, hunger, mouth dryness, nausea, vomit, and weakness) of wellbeing were compared perioperatively. Preoperative basic conditions of patients, postoperative complications, and their clinical outcomes were also recorded. RESULTS: Before anesthesia induction, gastric sonography score was higher in experiment group, while sucked fluid by gastroscopy was similar between 2 groups. And no patient had regurgitation. Moreover, gastric peristaltic score and operation score before operation were both lower in experiment group. Importantly, VAS scores for 3 parameters (thirst, hunger, and mouth dryness) were significantly lower in experiment patients. In addition, clinical outcomes including first time exhaust, first time for drinking water, the usage of hemostasis, postoperative complication, lengths of hospital stay, and in-hospital expense were not significantly different between 2 groups. CONCLUSIONS: Oral administration of carbohydrates preoperatively instead of fasting improves the feelings of thirst, hunger, and mouth dryness in patients following ESD surgery without enhancing risk of regurgitation. And, avoiding preoperative fasting with POC can decrease the degree of gastric peristalsis that may facilitate the successful completion of ESD surgery.

Cost Effectiveness of Endoscopic Resection vs Transanal Resection of Complex Benign Rectal Polyps.

BACKGROUND & AIMS: Complex benign rectal polyps can be managed with transanal surgery or with endoscopic resection (ER). Though the complication rate after ER is lower than transanal surgery, recurrence is higher. Patients lost to follow up after ER might therefore be at increased risk for rectal cancer. We evaluated the costs, benefits, and cost effectiveness of ER compared to 2 surgical techniques for removing complex rectal polyps, using a 50-year time horizon-this allowed us to capture rates of cancer development among patients lost from follow-up surveillance. METHODS: We created a Markov model to simulate the lifetime outcomes and costs of ER, transanal endoscopic microsurgery (TEM), and transanal minimally invasive surgery (TAMIS) for the management of a complex benign rectal polyp. We assessed the effect of surveillance by allowing a portion of the patients to be lost to follow up. We calculated the cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio or each intervention over a 50-year time horizon. RESULTS: We found that TEM was slightly more effective than TAMIS and ER (TEM, 19.54 QALYs; TAMIS, 19.53 QALYs; and ER, 19.53 QALYs), but ER had a lower lifetime discounted cost (ER cost $7161, TEM cost $10,459, and TAMIS cost $11,253). TEM was not cost effective compared to ER, with an incremental cost-effectiveness ratio of $485,333/QALY. TAMIS was dominated by TEM. TEM became cost effective when the mortality from ER exceeded 0.63%, or if the loss to follow up rate exceeded 25.5%. CONCLUSIONS: Using a Markov model, we found that ER, TEM, and TAMIS have similar effectiveness, but ER is less expensive, in management of benign rectal polyps. As the rate of loss to follow up increases, transanal surgery becomes more effective relative to ER.