Assessment of Attitudes Toward Initiation of Immediate Adjuvant Chemotherapy for Colon Cancer.

INTRODUCTION: Early initiation of chemotherapy after surgery for colon cancer has survival benefits. Immediate adjuvant chemotherapy (IAC) involves giving chemotherapy during surgical resection and immediately postoperatively. This novel approach has been shown to be safe, eliminating delays in adjuvant treatment that could increase the risk of micro-metastatic spread. The aim of this study was to assess the willingness of the general public to accept IAC. MATERIALS AND METHODS: Between March and April 2021, 800 telephone interviews were conducted with a sample of adult New York State residents. The Survey Research Institute of Cornell University conducted all surveys. Kruskal-Wallis, chi-squared, and Fisher's tests were conducted using R 4.0.2. RESULTS: Three scenarios were presented: (1) receiving IAC resulting in improved survival and quality of life, (2) finishing chemotherapy earlier without survival impact, and (3) finishing chemotherapy earlier but with possible side effects. Respondents with higher education were more likely to accept (1) & (2), males were more likely to accept (2) & (3), higher income respondents were more likely to accept (1) & (3), and those with more work hours were more likely to accept (2). Lastly, 16% responded they would be very or extremely likely, and 52% respondents would be somewhat likely or likely to accept intraoperative chemotherapy, even if it may not be necessary. CONCLUSIONS: Respondents were likely to accept IAC if offered. Given the known risk of delayed adjuvant chemotherapy (AC) in colon cancer, further research is warranted to determine the survival and quality of life (QOL) benefits of IAC.

Assessment of Anastomotic Viability With Spectroscopic Real-time Oxygen Saturation Measurement in a Porcine Study.

OBJECTIVE: Anastomotic leakage (AL) is a severe complication following intestinal procedures. Intra.Ox™ by ViOptix Inc (Newark, CA, USA) is a novel, FDA-approved spectroscopic device which enables real-time measurement of mixed tissue oxygen saturation (StO2). Using a porcine model, this study explores the correlation between StO2 measurements and AL formation as well as investigates the applicability of Intra.Ox™ in the clinical setting. METHODS: Eleven female swine were divided into 3 groups to explore AL formation in different ischemic conditions. Group 1: 100% mesenteric-vascular ligation, n = 3; Group 2: 50% ligation, n = 5; Group 3: No mesenteric ligation, n = 3. StO2 at the anastomotic line was measured before and after vessel ligation and anastomosis. Measurements were taken at 6 distinct locations along afferent and efferent loops. AL was evaluated on postoperative day 5 by re-laparotomy. RESULTS: AL rate was 100%, 60% and 0% in groups 1, 2 and 3, respectively. Post-anastomotic StO2 in group 1 (22.9 ± 18.5%) and 2 (39.2 ± 20.1%) were significantly lower than in group 3 (53.1 ± 8.3%, p<.0001). Post-anastomotic StO2 readings ≤40% indicated AL potential with 100% sensitivity,+ 80% specificity, positive predictive value of 85.7% and negative predictive value of 100%. CONCLUSION: This study demonstrates the value of Intra.Ox™ in assessing local perfusion and indicate the association between low StO2 and AL by providing accurate, real-time, noninvasive tissue oxygenation measurements at anastomotic sites. Further studies are required to investigate the clinical application of this novel device in intestinal surgery.

Assessment of Medical Industry Compensation to US Physicians by Gender.

Importance: It has been well established that female physicians earn less than their male counterparts in all specialties and ranks despite controlling for confounding variables. Objective: To investigate payments made from highest-grossing medical industry companies to female and male physicians and to assess compensation and engagement disparities based on gender. Design, Setting, and Participants: This retrospective, population-based cross-sectional study used data from the Open Payments database for the 5 female and 5 male physicians who received the most financial compensation from each of the 15 highest-grossing medical supply companies in the US from January 2013 to January 2019. Main Outcomes and Measures: The primary outcome was total general payments received by female and male physicians from medical industry over time and across industries. The secondary outcome was trends in industry payment to female and male physicians from 2013 to 2019. Results: Among the 1050 payments sampled, 1017 (96.9%) of the 5 highest earners were men and 33 (3.1%) were women. Female physicians were paid a mean (SD) of $41 320 ($88 695), and male physicians were paid a mean (SD) of $1 226 377 ($3 377 957) (P < .001). On multivariate analysis, male gender was significantly associated with higher payment after adjusting for rank, h-index, and specialty (mean [SD], $1 025 413 [$162 578]; P < .001). From 2013 to 2019, the payment gap between female and male physicians increased from $54 343 to $166 778 (P < .001). Conclusions and Relevance: This study found that male physicians received significantly higher payments from the highest-grossing medical industry companies compared with female physicians. This disparity persisted across all medical specialties and academic ranks. The health care industry gender payment gap continued to increase from 2013 to 2019, with a wider compensation gap in 2019.

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).

Changing Disparity of Gastric Cancer Incidence by Histological Types in US Race-Specific Populations.

BACKGROUND: The incidence pattern of gastric cancer by histological types across major race/ethnic groups is unknown. METHODS: Age-standardized rates from 1992-2016 by race/ethnicity were calculated using data from Surveillance, Epidemiology, and End Results Program (SEER). Annual percent changes (APCs) in rates and corresponding 95% confidence intervals (CIs) were calculated and pairwise comparison of rates between race/ethnic groups was performed using the Joinpoint Regression Program. Calendar periods of incidence rates of gastric cardia and non-cardia cancer by histological types across race/ethnicity groups were shown by figures. RESULTS: The White population has the highest incidence of gastric cardia adenocarcinoma and the incidence is keeping constant from 1992 through 2016 except the decreasing in the Asian population (AAPC = -1.4, 95%CI (-2.1, -0.8)). Although the incidence of non-cardia adenocarcinoma is decreasing in each group, the descending trend in the Asian population is the quickest (AAPC = -3.8, 95%CI (-4.0, -3.5)). Gastric carcinoids were observed to have statistically significant increasing trends in all race/ethnicity groups, especially in Hispanic women from 0.4 per 100,000 to 1.6 per 100,000 persons. The incidence of gastrointestinal stromal tumors (GISTs) is rising, with Non-Hispanic blacks having the highest incidence. CONCLUSION: This study demonstrated disparities in the incidence of gastric cancer by histological types among different race/ethnic groups. Further investigations are warranted to understand the changing incidence patterns by race/ethnicity.

Laparoscopic loop ileostomy reversal with intracorporeal anastomosis is associated with shorter length of stay without increased direct cost.

BACKGROUND: Laparoscopic ileostomy closure with intracorporeal anastomosis offers potential advantages over open reversal with extracorporeal anastomosis, including earlier return of bowel function and reduced postoperative pain. In this study, we aim to compare the outcome and cost of laparoscopic ileostomy reversal (utilizing either intracorporeal or extracorporeal anastomosis) with open ileostomy reversal. METHODS: A retrospective review of sequential patients undergoing elective loop ileostomy reversal between 2013 and 2016 at a single, high-volume institution was performed. Patients were stratified on the basis of operative approach: open reversal, laparoscopic-assisted reversal with extracorporeal anastomosis (LE), and laparoscopic reversal with intracorporeal anastomosis (LI). Linear and logistic regressions were utilized to perform multivariate analysis and determine risk-adjusted outcomes. RESULTS: Of 132 sequential cases of loop ileostomy reversal, 50 (38%) underwent open, 49 (37%) underwent LE, and 33 (22%) underwent LI. Demographic data and preoperative comorbidities were similar between the three cohorts. Median length of stay was significantly shorter for LI (52.1 h, p < 0.05) compared to open (69.0 h) and LE (69.6 h). After risk-adjusted analysis, length of stay was significant shorter in LI compared to LE (GM 0.78, 95% CI 0.64-0.93, p < 0.01) and open reversal (GM 0.78, 95% CI 0.66-0.93, p < 0.01). Risk-adjusted 30-day morbidity rates were similar for LI compared to LE (OR 0.43, 95% CI 0.081-2.33, p = 0.33) and open reversal (OR 0.53, 95% CI 0.09-3.125, p = 0.48). Median in-hospital direct cost was similar for LI ($6575.00), LE ($6722.50), and open reversal ($6181.00). CONCLUSION: Laparoscopic ileostomy reversal with intracorporeal anastomosis was associated with shorter length of stay without increased overall direct cost. The technique of laparoscopic ileostomy reversal warrants continued study in a randomized clinical trial.

Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial.

Importance: Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. Objective: To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Design, Setting, and Participants: Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Interventions: Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). Main Outcomes and Measures: The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Results: Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, -1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, -3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. Conclusions and Relevance: Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection. Trial Registration: isrctn.org Identifier: ISRCTN80500123.

Comparison of open, laparoscopic, and robotic approaches for total abdominal colectomy.

BACKGROUND: The utilization of minimally invasive surgery is increasing in colorectal surgery. We sought to compare the outcomes of patients who underwent elective open, laparoscopic, and robotic total abdominal colectomy. METHODS: The NIS database was used to examine the clinical data of patients who underwent an elective total colectomy procedure during 2009-2012. Multivariate regression analysis was performed to compare the three surgical approaches. RESULTS: We sampled a total of 26,721 patients who underwent elective total colectomy. Of these, 16,780 (62.8 %) had an open operation, while 9934 (37.2 %) had a minimally invasive approach (9614 laparoscopic surgery, and 326 robotic surgery). The most common indication for an operation was ulcerative colitis (31 %). Patients who underwent open surgery had significantly higher mortality and morbidity compared to laparoscopic (AOR 2.48, 1.30, P < 0.01) and robotic approaches (AOR 1.04, 1.30, P < 0.01 and P = 0.04, respectively). There was no significant difference in mortality and morbidity between the laparoscopic and robotic approaches (AOR 0.96, 1.03, P = 0.10, P = 0.78). However, conversion rate of laparoscopic surgery to open was significantly higher than that of robotic approach (13.3 vs. 1.5 %, P < 0.01). Patients who underwent laparoscopic surgery had significantly lower total hospital charges compared to patients who underwent open surgery (mean difference = $21,489, P < 0.01). Also, total hospital charges for a robotic approach were significantly higher than for a laparoscopic approach (mean difference = $15,595, P < 0.01). CONCLUSION: Minimally invasive approaches to total colectomy are safe, with the advantage of lower mortality and morbidity compared to an open approach. Although there was no significant difference in the morbidity between minimally invasive approaches, robotic surgery had a significantly lower conversion rate compared to laparoscopic approach. Total hospital charges are significantly higher in robotic surgery compared to laparoscopic approach.

Improving outcomes and cost-effectiveness of colorectal surgery.

In order to truly make an impact on improving the cost effectiveness, and most importantly, the outcomes of patients undergoing colorectal surgery, all aspects of care need to be scrutinized, re-evaluated, and refined. To accomplish this, everything from the way we train surgeons to the adoption of a minimally invasive approach for colorectal disease, along with the use of adjunct intraoperative measures to decrease morbidity and mortality, may all need to be incorporated within an ERAS program. Only then will this approach lead the provider to a patient-centric care plan which can successfully reduce metrics such as morbidity, mortality, and length of stay (even with the obligatory readmission rate) and provide it all at a lower cost of care.

A nationwide analysis of the use and outcomes of epidural analgesia in open colorectal surgery.

INTRODUCTION: Epidural analgesia has demonstrated superiority over conventional analgesia in controlling pain following open colorectal resections. Controversy exists regarding cost-effectiveness and postoperative outcomes. METHODS: The Nationwide Inpatient Sample (2002-2010) was retrospectively reviewed for elective open colorectal surgeries performed for benign and malignant conditions with or without the use of epidural analgesia. Multivariate regression analysis was used to compare outcomes between epidural and conventional analgesia. RESULTS: A total 888,135 patients underwent open colorectal resections. Epidural analgesia was only used in 39,345 (4.4 %) cases. Epidurals were more likely to be used in teaching hospitals and rectal cancer cases. On multivariate analysis, in colonic cases, epidural analgesia lowered hospital charges by US$4,450 (p < 0.001) but was associated with longer length of stay by 0.16 day (p < 0.05) and a higher incidence of ileus (OR = 1.17; p < 0.01). In rectal cases, epidural analgesia was again associated with lower hospital charges by US$4,340 (p < 0.001) but had no effect on ileus and length of stay. The remaining outcomes such as mortality, respiratory failure, pneumonia, anastomotic leak, urinary tract infection, and retention were unaffected by the use of epidurals. CONCLUSION: Epidural analgesia in open colorectal surgery is safe but does not add major clinical benefits over conventional analgesia. It appears however to lower hospital charges.

Robotic-assisted colorectal surgery in the United States: a nationwide analysis of trends and outcomes.

BACKGROUND: While robotic-assisted colorectal surgery (RACS) is becoming increasingly popular, data comparing its outcomes to other established techniques remain limited to small case series. Moreover, there are no large studies evaluating the trends of RACS at the national level. METHODS: The Nationwide Inpatient Sample 2009-2010 was retrospectively reviewed for robotic-assisted and laparoscopic colorectal procedures performed for cancer, benign polyps, and diverticular disease. Trends in different settings, indications, and demographics were analyzed. Multivariate regression analysis was used to compare selected outcomes between RACS and conventional laparoscopic surgery (CLS). RESULTS: An estimated 128,288 colorectal procedures were performed through minimally invasive techniques over the study period, and RACS was used in 2.78 % of cases. From 2009 to 2010, the use of robotics increased in all hospital settings but was still more common in large, urban, and teaching hospitals. Rectal cancer was the most common indication for RACS, with a tendency toward its selective use in male patients. On multivariate analysis, robotic surgery was associated with higher hospital charges in colonic ($11,601.39; 95 % CI 6,921.82-16,280.97) and rectal cases ($12,964.90; 95 % CI 6,534.79-19,395.01), and higher rates of postoperative bleeding in colonic cases (OR = 2.15; 95 % CI 1.27- 3.65). RACS was similar to CLS with respect to length of hospital stay, morbidity, anastomotic leak, and ileus. Conversion to open surgery was significantly lower in robotic colonic and rectal procedures (0.41; 95 % CI 0.25-0.67) and (0.10; 95 % CI 0.06-0.16), respectively. CONCLUSIONS: The use of RACS is still limited in the United States. However, its use increased over the study period despite higher associated charges and no real advantages over laparoscopy in terms of outcome. The one advantage is lower conversion rates.

Robotic surgery: colon and rectum.

Although robotic technology aims to obviate some of the limitations of conventional laparoscopic surgery, the role of robotics in colorectal surgery is still largely undefined and different with respect to its application in abdominal versus pelvic surgery. This review aims to elucidate current developments in colorectal robotic surgery.In colon surgery, robotic techniques are associated with longer operative times and higher costs compared with laparoscopic surgery. However, robotics provides a stable camera platform and articulated instruments that are not subject to human tremors. Because of these advantages, robotic systems can play a role in complex procedures such as the dissection of lymph nodes around major vessels. In addition robot-assisted hand-sewn intracorporeal anastomoses can be easily performed by the surgeon, without a substantial need for a competent assistant. At present, although the short-term outcomes and oncological adequacy of robotic colon resection have been observed to be acceptable, the long-term outcomes of robotic colon resection remain unknown.In rectal surgery, robotic-assisted surgery for rectal cancer can be carried out safely and in accordance with current oncological principles. However, to date, the impact of robotic rectal surgery on the long-term oncological outcomes of minimally invasive total mesorectal excision remains undetermined. Robotic total mesorectal excision may allow for better preservation of urinary and sexual functions, and robotic surgery may attenuate the learning curve for laparoscopic rectal resection. However, a major drawback to robotic rectal surgery is the high cost involved.Large-scale prospective randomized clinical trials such as the international randomized trial ROLARR are required to establish the benefits of robotic rectal surgery.

Risk factors for anastomotic leakage after anterior resection for rectal cancer.

BACKGROUND: The risk factors for anastomotic leak (AL) after anterior resection have been evaluated in several studies and remain controversial as the findings are often inconsistent or inconclusive. OBJECTIVE: To analyze the risk factors for AL after anterior resection in patients with rectal cancer. DESIGN: Retrospective analysis. SETTING: The Nationwide Inpatient Sample 2006 to 2009. PATIENTS: A total of 72 055 patients with rectal cancer who underwent elective anterior resection. MAIN OUTCOME MEASURES: To build a predictive model for AL using demographic characteristics and preadmission comorbidities, the lasso algorithm for logistic regression was used to select variables most predictive of AL. RESULTS: The AL rate was 13.68%. The AL group had higher mortality vs the non-AL group (1.78% vs 0.74%). Hospital length of stay and cost were significantly higher in the AL group. Laparoscopic and open resections with a diverting stoma had a higher incidence of AL than those without a stoma (15.97% vs 13.25%). Multivariate analysis revealed that weight loss and malnutrition, fluid and electrolyte disorders, male sex, and stoma placement were associated with a higher risk of AL. The use of laparoscopy was associated with a lower risk of AL. Postoperative ileus, wound infection, respiratory/renal failure, urinary tract infection, pneumonia, deep vein thrombosis, and myocardial infarction were independently associated with AL. CONCLUSIONS: Anastomotic leak after anterior resection increased mortality rates and health care costs. Weight loss and malnutrition, fluid and electrolyte disorders, male sex, and stoma placement independently increased the risk of leak. Laparoscopy independently decreased the risk of leak. Further studies are needed to delineate the significance of these findings.

An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer.

PURPOSE: There is growing enthusiasm for robotic-assisted laparoscopic operations across many surgical specialities, including colorectal surgery, often not supported by robust clinical or cost-effectiveness data. A proper assessment of this new technology is required, prior to widespread recommendation or implementation. METHODS/DESIGN: The ROLARR trial is a pan-world, prospective, randomised, controlled, unblinded, superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. It will investigate differences in terms of the rate of conversion to open operation, rate of pathological involvement of circumferential resection margin, 3-year local recurrence, disease-free and overall survival rates and also operative morbidity and mortality, quality of life and cost-effectiveness. The primary outcome measure is the rate of conversion to open operation. For 80% power at the 5% (two-sided) significance level, to identify a relative 50% reduction in open conversion rate (25% to 12.5%), 336 patients will be required. The target recruitment is 400 patients overall to allow loss to follow-up. Patients will be followed up at 30 days and 6 months post-operatively and then annually until 3 years after the last patient has been randomised. DISCUSSION: In many centres, robotic-assisted surgery is being implemented on the basis of theoretical advantages, which have yet to be confirmed in practice. Robotic surgery is an expensive health care provision and merits robust evaluation. The ROLARR trial is a pragmatic trial aiming to provide a comprehensive evaluation of both robotic-assisted and standard laparoscopic surgery for the curative resection of rectal cancer.