Attitudes of physicians and patients toward immediate and intraoperative chemotherapy treatment in colon cancer.

INTRODUCTION: We have shown in a Phase I trial that immediate adjuvant chemotherapy (IAC) during surgical resection and immediately postoperative is safe and feasible in patients with colon cancer (CC). IAC avoids delays in adjuvant treatment and has the potential to improve survival and quality of life. We aim to determine patients and providers attitudes toward this novel multidisciplinary treatment approach. METHODS: Two web-based surveys were administered to newly diagnosed CC patients, survivors, surgeons and oncologists. Surveys assessed treatment preferences and perceived barriers to IAC. Chi-square tests were conducted to compare differences between patients' and providers' responses. RESULTS: Responses were collected from 35 patients and 40 providers. Patients were more willing to: (1) proceed with IAC to finish treatment earlier thus possibly improving quality of life (p = 0.001); (2) proceed with IAC despite potential side effects (p < 0.001); and (3) proceed with a dose of intraoperative chemotherapy even if on final pathology, may not have been needed (p = 0.002). Patients were more likely to indicate no barriers to collaborative care (p = 0.001) while providers were more likely to cite that it is time consuming, thus a barrier to participation (p = 0.001), has scheduling challenges (p = 0.001), and physicians are not available to participate (p = 0.003). CONCLUSIONS: We observed a discordance between what providers and patients value in perioperative and adjuvant CC treatment. Patients are willing to accept IAC despite potential side effects and without survival benefit, highlighting the importance of understanding patient preference.

Effect of Specimen Extraction Site on Postoperative Incisional Hernia After Minimally Invasive Right Colectomy.

BACKGROUND: Incisional hernia (IH) is a known complication after colorectal surgery. Despite advances in minimally invasive surgery, colorectal surgery still requires extraction sites for specimen retrieval, increasing the likelihood of postoperative IH development.The objective of this study is to determine the effect of specimen extraction site on the rate of IH after minimally invasive right-sided colectomy for patients with available imaging. STUDY DESIGN: This is a retrospective multi-institutional cohort study at 2 large academic medical centers in the US. Adults who underwent right-sided minimally invasive colectomy from 2012-2020 with abdominal imaging available at least 1 year postoperatively were included in the analysis. The primary exposure was specimen extraction via a midline specimen extraction vs Pfannenstiel specimen extraction. The main outcome was the development of IH at least 1 year postoperatively as visualized on CT scan. RESULTS: Of the 341 patients sampled, 194 (57%) had midline specimen extraction and 147 (43%) had a Pfannenstiel specimen extraction. Midline extraction patients were older (66 ± 15 vs 58 ± 16; P<0.001) and had a higher rate of previous abdominal operation (99, 51% vs 55, 37%, P=0.01). The rate of IH was higher in midline extraction at 25% (n=48) compared with Pfannenstiel extraction (n=0, 0%) (P<0.001). The average length of stay was higher in the midline extraction group at 5.1±2.5 compared with 3.4±3.1 days in the Pfannenstiel extraction group (P<0.001). Midline extraction was associated with IH development (OR: 24.6; 95% CI 1.89-319.44; p=0.004). Extracorporeal anastomosis was associated with a higher IH rate (OR: 25.8; 95% CI 2.10-325.71; P=0.002). CONCLUSION: Patients who undergo Pfannenstiel specimen extraction have a lower risk of IH development compared with those who undergo midline specimen extraction.

Discrepancies in Conflict-of-Interest Disclosures Among Physicians Receiving Compensation for Monoclonal Antibody Drugs.

BACKGROUND: Monoclonal antibody drugs are widely used, highly marketed, expensive compounds. Relationships between these drug manufacturers and physicians may increase the potential for bias in relevant studies. OBJECTIVE: The aim of this study is to determine the rate of disclosures among physicians receiving compensations for monoclonal antibody drugs (MAbDs). DESIGN: This is a retrospective, population-based, cross-sectional study. PARTICIPANTS: The 50 physicians who received the highest financial compensation for selected MAbDs from 2016 to 2020 were included. MAIN MEASURES: Payment data were obtained from the Open Payments Database, bibliometric data were obtained from SCOPUS, and disclosure data were obtained from relevant publications found in PubMed. The primary outcome was rate of disclosure concordance between self-declared conflict-of-interest and industry-reported payments documented in the Open Payments Database. KEY RESULTS: Of the 50 physicians examined, 74% (N = 37) had publications examined. A cumulative 6170 payments totaling $18,484,228 were analyzed. A total of 418 relevant papers were reviewed. The rate of full disclosure (all relevant financial relationships disclosed) was 39.5%, partial disclosure (some but not all financial relationships disclosed) was 28.0%, and no disclosure was 26.3%. 6.2% did not require disclosure. Publications authored by dermatologists had the highest rate of full disclosure at 49.3%. There was no association between h-index and disclosure rate. Practice guidelines had the highest rate of full disclosure at 69.2% while basic science papers had the lowest (0%). Lastly, substantial variations in specific journal disclosure policies were found. CONCLUSIONS: Substantial inconsistencies were found between self-reported disclosures and the Open Payments Database among physicians receiving high compensation for MAbDs. A policy of full disclosure for all publications should be adopted.

Neoadjuvant botensilimab plus balstilimab response pattern in locally advanced mismatch repair proficient colorectal cancer.

In patients with locally advanced cancer without distant metastases, the neoadjuvant setting presents a platform to evaluate new drugs. For mismatch repair proficient/microsatellite stable (pMMR/MSS) colon and rectal cancer, immunotherapy has shown limited efficacy. Herein, we report exceptional responses observed with neoadjuvant botensilimab (BOT), an Fc-enhanced next-generation anti-CTLA-4 antibody, alongside balstilimab (BAL; an anti-PD-1 antibody) in two patients with pMMR/MSS colon and rectal cancer. The histological pattern of rapid immune response observed ("inside-out" (serosa-to-mucosa) tumor regression) has not been described previously in this setting. Spatial biology analyses (RareCyte Inc.) reveal mechanisms of actions of BOT, a novel innate-adaptive immune activator. These observations have downstream implications for clinical trial designs using neoadjuvant immunotherapy and potentially sparing patients chemotherapy.

The Demographics and Alpha Omega Alpha Honor Medical Society Membership Status of Surgery's Top Leadership.

PURPOSE: Diversity and equity are priorities of many academic Departments of Surgery (DoS). Induction into Alpha Omega Alpha Honor Medical Society (AOA) denotes academic excellence and can potentially propel an academic career. Research has demonstrated that underrepresented in medicine (URM) students are less likely to be elected to AOA. In this study, we aim to examine the Chairs in American departments of surgery to examine their gender, racial, and ethnic background and AOA membership status. METHOD: An anonymous survey was generated via REDCap and electronically sent to the Chair of Surgery at the top 75 DoS based on "Reputation" on Doximity Residency Navigator 2020-2021. Seven chairs with non-publicly accessible email addresses were excluded. RESULTS: Of the eligible chairs (N = 68), 38 (55.9%) completed the survey, of which 34 (89.5%) identified as men. AOA membership was reported in 65.8% (n = 25) respondents, with 8% (n = 2) self-identifying as women and 92% (n = 23) self-identifying as men. Of the men respondents, 74% (n = 25) reported AOA membership, while 50% of women (n = 2) reported AOA membership. Of the AOA chairs, 4% (n = 1) self-identified as Asian while 96% (n = 24) self-identified as White. The majority (57.9%, n = 22) of eligible chair respondents were White, men, and AOA members. Of the 25 AOA members, 18 (72.0%) felt their membership has positively impacted their career. CONCLUSIONS: We found that the majority of American Surgical Chairs self-identify as white men. The number of men who were AOA was higher than women chairs.

Intraoperative Anastomotic Evaluation Methods: Rigid Proctoscopy Versus Flexible Endoscopy.

INTRODUCTION: Rigid proctosigmoidoscopy (RP) and flexible sigmoidoscopy (FS) are two modalities commonly used for intraoperative evaluation of colorectal anastomoses. This study seeks to determine whether there is an association between the endoscopic modality used to evaluate colorectal anastomoses and the rate of anastomotic leak (AL), organ space infection, and overall infectious complication. METHODS: The 2012-2018 American College of Surgeons National Surgical Quality Improvement Program database was queried for patients undergoing colorectal anastomoses. Anastomotic evaluation method (RP versus FS) was identified by Current Procedural Terminologycoding and used for group classification. Outcomes measured included AL, organ space infections, and overall infection. Multivariable logistic regression analysis for predicting AL was performed. RESULTS: We identified 7100 patients who underwent a colorectal anastomosis with intraoperative endoscopic evaluation. RP was utilized in 3397 (47.8%) and FS in 3703 (52.2%) patients. RP was used more commonly in diverticulitis (44.5% versus 36.2%, P < 0.01), while FS was used more frequently in malignancy (47.5% versus 36.7%, P < 0.01). Anastomotic evaluation with FS was associated with lower rates of organ space infection (3.8% versus 4.8%, P = 0.025) and AL (2.9% versus 3.8%, P = 0.028) compared to RP. On multivariate logistic regression modeling, anastomotic evaluation with RP was associated with a higher risk of AL (odds ratio 1.403, 95% CI 1.028-1.916, P = 0.033) compared to FS. CONCLUSIONS: Compared to FS, rigid proctosigmoidoscopic evaluation of a colorectal anastomosis was associated with an increased rate of AL and organ space infection.

Population-Based Analysis of National Comprehensive Cancer Network (NCCN) Guideline Adherence for Patients with Anal Squamous Cell Carcinoma in California.

PURPOSE: We analyzed adherence to the National Comprehensive Cancer Network treatment guidelines for anal squamous cell carcinoma in California and the associated impacts on survival. METHODS: This was a retrospective study of patients in the California Cancer Registry aged 18 to 79 years with recent diagnoses of anal squamous cell carcinoma. Predefined criteria were used to determine adherence. Adjusted odds ratios and 95% confidence intervals were estimated for those receiving adherent care. Disease-specific survival (DSS) and overall survival (OS) were examined with a Cox proportional hazards model. RESULTS: 4740 patients were analyzed. Female sex was positively associated with adherent care. Medicaid status and low socioeconomic status were negatively associated with adherent care. Non-adherent care was associated with worse OS (Adjusted HR 1.87, 95% CI = 1.66, 2.12, p < 0.0001). DSS was worse in patients receiving non-adherent care (Adjusted HR 1.96, 95% CI = 1.56, 2.46, p < 0.0001). Female sex was associated with improved DSS and OS. Black race, Medicare/Medicaid, and low socioeconomic status were associated with worse OS. CONCLUSIONS: Male patients, those with Medicaid insurance, or those with low socioeconomic status are less likely to receive adherent care. Adherent care was associated with improved DSS and OS in anal carcinoma patients.

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.

A human vascularized microtumor model of patient-derived colorectal cancer recapitulates clinical disease.

Accurately modeling tumor biology and testing novel therapies on patient-derived cells is critically important to developing therapeutic regimens personalized to a patient's specific disease. The vascularized microtumor (VMT), or "tumor-on-a-chip," is a physiologic preclinical cancer model that incorporates key features of the native human tumor microenvironment within a transparent microfluidic platform, allowing rapid drug screening in vitro. Herein we optimize methods for generating patient-derived VMT (pVMT) using fresh colorectal cancer (CRC) biopsies and surgical resections to test drug sensitivities at the individual patient level. In response to standard chemotherapy and TGF-ßR1 inhibition, we observe heterogeneous responses between pVMT derived from 6 patient biopsies, with the pVMT recapitulating tumor growth, histological features, metabolic heterogeneity, and drug responses of actual CRC tumors. Our results suggest that a translational infrastructure providing rapid information from patient-derived tumor cells in the pVMT, as established in this study, will support efforts to improve patient outcomes.

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.

Conflict of Interest Disclosure Among the Highest Earning Physicians Receiving Compensation From Vascular Device Companies.

OBJECTIVE: To characterize the association between payments made by vascular device companies to clinicians, and the conflict of interest (COI) declarations on relevant publications. SUMMARY BACKGROUND DATA: Close association between medical device companies and clinicians is essential in the advancement of surgical technology. When evaluating the efficacy of novel equipment, identification of these relationships can minimize the risk of bias in relevant studies. METHODS: Using the Open Payments Database (OPD), the 10 highest compensated clinicians from 10 vascular device companies were identified. In the population based bibliometric analysis, general payments, number of payments, h-index, and academic rank were identified. PubMed and Scopus were queried to identify author publications. Relevance to payment received and COI disclosures were identified for each article. RESULTS: The physicians identified earned $33,442,266.74 with a median of $92,500 in 2017. The authors published an average of 6.46+/-9.08 articles in 2018. Relevant COI was identified in 74%. In 50.5% of the relevant publications was a COI declared. The median h index of authors was 18+/-23. Community based physicians had a higher rate of COI disclosure (65.6%) compared to academic physicians (47.6%) (P = .008). Low h-index authors had a higher rate of COI declaration (71.4%) compared to high h-index (43.6%) (P = .001). CONCLUSION: A high degree of inconsistency was found between self-declared COI and relevant articles published by the highest compensated physicians. We propose a policy of full disclosure and the addition of a link to each author's OPD page on all publications to increase access to potential COI.

Immediate Adjuvant Chemotherapy in Non-Metastatic Colon Cancer: Phase I Trial Evaluating a Novel Treatment Protocol.

BACKGROUND: The optimal timing of adjuvant chemotherapy (AC) in non-metastatic colon cancer is poorly defined. Delays in AC result in decreased survival. Effective cytotoxic treatments should be considered during the perioperative phase of care. The immediate adjuvant chemotherapy (IAC) concept intends to capitalize on the therapeutic benefits that can be achieved in the perioperative period. We aim to demonstrate that IAC is safe and tolerable. PATIENT AND METHODS: Microsatellite stable invasive adenocarcinomas were treated with intravenous Leucovorin 20 mg/m2 and single dose of 5-Flurouracil 400mg/m2 at the time of surgery. High-risk stage II and stage III received the first dose of standard AC at 14 days after surgery. Serial measurements of blood-based biomarkers were measured. Quality of life (QOL) was measured using EORTC QLQ-C30. RESULTS: Of the 20 patients recruited, 40% had final pathology of stage III, 40% stage II and 20% stage I. All patients received intra-operative chemotherapy with no associated morbidity. Median length of stay was 2 days (range of 2-4). There was no intraoperative morbidity with 5% (N = 1) grade 3 complication. AC was administered to 65% of patients. The median time to AC was 14 days (range 14-36). Overall quality of life and health scores were similar before surgery and at 30-day postoperatively (P < .05). CONCLUSIONS: A protocol based on IAC starting at the time of surgical resection was found to be safe and feasible with no adverse effects on surgical morbidity or quality of life. Further prospective studies are needed to explore the oncologic benefit of this novel systemic treatment approach.

Misdiagnosis of appendiceal neoplasms as ovarian tumors: Impact of prior gynecologic surgery on definitive cytoreduction and HIPEC.

BACKGROUND: Female patients with pelvic/adnexal masses often undergo gynecologic operations due to presumed ovarian origin. The diagnosis of an appendiceal tumor is often only made postoperatively after suboptimal cytoreduction has been performed. We hypothesized that an index gynecological procedure increases the morbidity of definitive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) in patients with appendiceal mucinous tumors. METHODS: A single-center retrospective review was performed to identify female patients undergoing CRS/HIPEC for appendiceal tumors from 2012 to 2020. RESULTS: During the 8-year period, CRS/HIPEC was performed in 36 female patients with appendiceal mucinous tumors. Eighteen patients (50.0%) had received a prior pelvic operation by gynecologists (PPO Group) for presumed ovarian origin before referral for definitive CRS/HIPEC. The median peritoneal cancer index (PCI) was higher in the PPO group (21 vs. 9, p = 0.04). The median number of days from gynecologic procedure to definitive CRS/HIPEC was 169 days. Compared to patients who did not undergo a prior gynecologic operation, those in the PPO group had higher intraoperative blood loss (650 vs 100 mL, p < 0.01) during CRS/HIPEC as well as longer length of stay (12 vs 8 days, p = 0.02) and higher overall morbidity (72.3% vs 33.3%, p = 0.02). After controlling for PCI, prior gynecologic operation increased risk of 30-day morbidity after definitive CRS/HIPEC (OR 11.6, p < 0.01). CONCLUSION: A multi-disciplinary approach is needed for the primary evaluation of patients with pelvic masses of undetermined origin. A gynecological resection is associated with increased morbidity during definitive cytoreduction and HIPEC for appendiceal mucinous tumors.

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).

Outcomes of colostomy takedown following Hartmann's procedure: successful restoration of continuity comes with a high risk of morbidity.

AIM: Restoration of bowel continuity following a Hartmann's procedure is a major surgical undertaking associated with significant morbidity. The aim of this study was to review the authors' experience with Hartmann's reversal. METHOD: This was a retrospective review of consecutive patients from institutional databases who were selected to undergo open or laparoscopic Hartmann's reversal at two tertiary academic referral centres and a public safety net hospital (2010-2019). The main outcome measure was the rate of successful stoma reversal. Secondary outcomes included 30-day postoperative outcomes and procedural details. RESULTS: One hundred and fifty patients underwent attempted reversal during the study period, which was successful in all but three patients (98%). Patients were 59% Hispanic and 73% male, with a mean age of 48.7 ± 14.1 years, mean American Society of Anesthesiologists classification of 2.2 ± 0.6 and mean body mass index (BMI) of 28.6 ± 5.3 kg/m2 , with 39% of patients having a BMI > 30 kg/m2 . The mean time interval between the index procedure and reversal was 14.4 months, 53% of the index cases were performed at outside institutions and the most common index diagnoses were diverticulitis (54%), abdominal trauma (16%) and colorectal malignancy (15%). In 22% of cases a laparoscopic approach was used, with 42% of these requiring conversion to open. Proximal diverting stomas were created in 32 patients (21%), of which 94% were reversed. The overall morbidity rate was 54%, comprising ileus (32%), wound infection (15%) and anastomotic leak (6%), with a major morbidity rate (Clavien-Dindo ≥ 3) of 23%. CONCLUSION: Hartmann's reversal remains a highly morbid procedure. Our results suggest that operative candidates can be successfully reversed, but there is significant morbidity associated with restoration of intestinal continuity, particularly in obese patients. A laparoscopic approach may decrease morbidity in selected patients but such cases have a high conversion rate.

Evaluation of Pelvic Anastomosis by Endoscopic and Contrast Studies Prior to Ileostomy Closure: Are Both Necessary? A Single Institution Review.

Contrast enema is the gold standard technique for evaluating a pelvic anastomosis (PA) prior to ileostomy closure. With the increasing use of flexible endoscopic modalities, the need for contrast studies may be unnecessary. The objective of this study is to compare flexible endoscopy and contrast studies for anastomotic inspection prior to defunctioning stoma reversal. Patients with a protected PA undergoing ileostomy closure between July 2014 and June 2019 at our institution were retrospectively identified. Demographics and clinical outcomes in patients undergoing preoperative evaluation with endoscopic and/or contrast studies were analyzed. We identified 207 patients undergoing ileostomy closure. According to surgeon's preference, 91 patients underwent only flexible endoscopy (FE) and 100 patients underwent both endoscopic and contrast evaluation (FE + CE) prior to reversal. There was no significant difference in pelvic anastomotic leak (2.2% vs. 1%), anastomotic stricture (1.1% vs. 6%), pelvic abscess (2.2% vs. 3.0%), or postoperative anastomotic complications (4.4% vs. 9%) between groups FE and FE + CE (P > .05). Flexible endoscopy alone appears to be an acceptable technique for anastomotic evaluation prior to ileostomy closure. Further studies are needed to determine the effectiveness of different diagnostic modalities for pelvic anastomotic inspection.

Improved survival with adjuvant chemotherapy in locally advanced rectal cancer patients treated with preoperative chemoradiation regardless of pathologic response.

OBJECTIVE: The aim of this study is to examine the effect of postoperative chemotherapy on survival in patients with stage II or III rectal adenocarcinoma who undergo neoadjuvant chemoradiation (CRT) and surgical resection. METHODS: A retrospective review of the National Cancer Database (NCDB) from 2006 to 2013 was performed. Cases were analyzed based on pathologic complete response (pCR) status and use of adjuvant therapy. The Kaplan-Meier method was used to estimate overall survival probabilities. RESULTS: 23,045 cases were identified, of which 5832 (25.31%) achieved pCR. In the pCR group, 1513 (25.9%) received adjuvant chemotherapy, and in the non-pCR group, 5966 (34.7%) received adjuvant therapy. In the pCR group, five-year survival probability was 87% (95% CI 84%-89%) with adjuvant therapy and 81% (95% CI 79%-82%) without adjuvant therapy. In the non-pCR group, five-year survival probability was 78% (95% CI 76%-79%) with adjuvant therapy and 70% (95% CI 69%-71%) without adjuvant therapy. In the non-pCR and node-negative subgroup (ypN-), five-year survival probability was 86% (95% CI 84%-88%) with adjuvant therapy and 76% (95% CI 74%-77%) without adjuvant therapy. In the non-pCR and node-positive subgroup (ypN+), five-year survival probability was 67% (95% CI 65%-70%) with adjuvant therapy and 60% (95% CI 58%-63%) without adjuvant therapy. CONCLUSIONS: Adjuvant chemotherapy in stage II or III rectal adenocarcinoma is associated with increased five-year survival probability regardless of pCR status. We observed similar survival outcomes among non-pCR ypN- treated with adjuvant chemotherapy compared with patients achieving pCR treated with adjuvant chemotherapy.

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.

Association of Compensation From the Surgical and Medical Device Industry to Physicians and Self-declared Conflict of Interest.

Importance: Surgical and medical device manufacturers have a cooperative relationship with clinicians. When evaluating published works, one should assess the integrity and academic credentials of the authors, who serve as putative experts. A relationship with a relevant manufacturer may increase the potential risk for bias in relevant studies. Objective: To characterize the association of industrial payments by device manufacturers, self-declared conflict of interest (COI), and relevance of publications among physicians receiving the highest compensation. Design, Setting, and Participants: This population-based bibliometric analysis identified 10 surgical and medical device manufacturing companies and the 10 physicians receiving the highest compensation from each company using the 2015 Open Payments Database (OPD) general payments data. For each of the 100 physicians, the total amount of general payments, number of payments, institution type, and academic rank were recorded. Royalty or license payments were excluded. A search of PubMed identified articles published by each physician from January 1 through December 31, 2016, and their associated COI declaration. Scopus was used to identify bibliometric data reported as the h index (number of papers by a researcher with at least h citations each). Main Outcomes and Measures: Discrepancy between self-declared COI and industry payments. Results: The 100 physicians included in the sample population (88% men) were paid a total of $12 446 969, with a median payment of $95 993. Fifty physicians (50.0%) were faculty at academic institutions. The mean (SD) h index was 18 (18; range, 0-75) for the authors. In 2016, 412 articles were published by these physicians, with a mean (SD) of 4 (6) publications (range, 0-25) and median of 1 (36 physicians had no publications). Of these articles, 225 (54.6%) were relevant to the general payments received by the authors. Only in 84 of the 225 relevant publications (37.3%) was the potential COI declared by the authors. Conclusions and Relevance: A high level of inconsistency was found between self-declared COI and the OPD among the physicians receiving the highest industry payments. Therefore, a policy of full disclosure for all publications, regardless of relevance, is proposed. No statistically significant association was demonstrated between academic rank or productivity and industrial payments.