Perioperative liberal versus restrictive fluid strategies and postoperative outcomes: a systematic review and metanalysis on randomised-controlled trials in major abdominal elective surgery.

BACKGROUND: Postoperative complications impact on early and long-term patients' outcome. Appropriate perioperative fluid management is pivotal in this context; however, the most effective perioperative fluid management is still unclear. The enhanced recovery after surgery pathways recommend a perioperative zero-balance, whereas recent findings suggest a more liberal approach could be beneficial. We conducted this trial to address the impact of restrictive vs. liberal fluid approaches on overall postoperative complications and mortality. METHODS: Systematic review and meta-analysis, including randomised controlled trials (RCTs). We performed a systematic literature search using MEDLINE (via Ovid), EMBASE (via Ovid) and the Cochrane Controlled Clinical trials register databases, published from 1 January 2000 to 31 December 2019. We included RCTs enrolling adult patients undergoing elective abdominal surgery and comparing the use of restrictive/liberal approaches enrolling at least 15 patients in each subgroup. Studies involving cardiac, non-elective surgery, paediatric or obstetric surgeries were excluded. RESULTS: After full-text examination, the metanalysis finally included 18 studies and 5567 patients randomised to restrictive (2786 patients; 50.0%) or liberal approaches (2780 patients; 50.0%). We found no difference in the occurrence of severe postoperative complications between restrictive and liberal subgroups [risk difference (95% CI) = 0.009 (- 0.02; 0.04); p value = 0.62; I2 (95% CI) = 38.6% (0-66.9%)]. This result was confirmed also in the subgroup of five studies having a low overall risk of bias. The liberal approach was associated with lower overall renal major events, as compared to the restrictive [risk difference (95% CI) = 0.06 (0.02-0.09); p value = 0.001]. We found no difference in either early (p value = 0.33) or late (p value = 0.22) postoperative mortality between restrictive and liberal subgroups CONCLUSIONS: In major abdominal elective surgery perioperative, the choice between liberal or restrictive approach did not affect overall major postoperative complications or mortality. In a subgroup analysis, a liberal as compared to a restrictive perioperative fluid policy was associated with lower overall complication renal major events, as compared to the restrictive. TRIAL REGISTRATION: CRD42020218059; Registration: February 2020, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=218059 .

How can we improve perinatal care in isolated multiple intestinal atresia? A retrospective study with a 30-year literature review.

INTRODUCTION: Multiple intestinal atresia (MIA) is a rare cause of neonatal intestinal obstruction. To provide an overview of the current prenatal, surgical, and nutritional management of MIA, we report our experience and a literature review of papers published after 1990. METHODS: All cases of isolated MIA (non-hereditary, not associated with apple-peel syndrome or gastroschisis) treated at our institution between 2005 and 2016 were reviewed and compared with cases found in the literature. RESULTS: Seven patients were prenatally suspected of having intestinal obstruction and were postnatally diagnosed with MIA, with a mean 1.7 (1-2) resections-anastomoses (RA) and 6 (1-10) strictureplasties performed, resulting in a mean resected bowel length of 15.1cm (15-25 cm). Median time to full oral feed was 46 days (14-626 days). All patients were alive and none had orality disorder after a mean follow-up of 3.1 years (0.2-8.1 years). Three surgical strategies were found in the literature review: multiple RA (68%, 34/50) including Santulli's technique in four of 34 (12%) and anastomoses over a transanastomotic tube (32%, 16/50), with a 98% survival rate, and short-bowel syndrome for only two patients. CONCLUSION: Bowel-sparing surgery and appropriate medical management are key to ensuring a favorable nutritional and gastrointestinal outcome and a good prognosis. Prenatal assessment and standardization of the surgical course of treatment remain challenging.

Strictureplasties performed by laparoscopic approach for complicated Crohn's disease. A prospective, observational, cohort study.

BACKGROUND: Laparoscopy is considered the best surgical approach for Crohn's Disease (CD), and strictureplasty a reliable alternative to intestinal resection. Nevertheless, their association has never been evaluated. AIM: To investigate feasibility and safety of conventional (SP) and non-conventional (NCSP) strictureplasties, using laparoscopy, for complicated CD. METHODS: Starting January 2008, a prospective cohort study was performed, in consecutive, unselected patients, undergoing primary surgery for CD (Group-A). The residential database (CD-CARD) was used for the retrospective extraction of control patients (Group-B). Univariate and multi-variate analysis of pre-operative characteristics, intra-operative findings, morbidity, and intra-abdominal septic complications (IASCs) was performed. RESULTS: Between January 2008 and December 2019, 331 patients received 162 SPs, 138 NCSPs, and 373 resections (Group-A). From the CD-CARD, 227 control patients received 159 SPs, 117 NCSPs, and 271 resections (Group-B) (ns). Preoperatively, Group-A presented batter nutritional status and received more biological therapies, Group-B more steroids. Group-A presented less abdominal abscesses, planned ostomies, minor complications, shorter operating time and hospitalization than Group-B, but similar major complications, IASCs and anastomotic leaks. IASCs were related to older age, elevated inflammatory indices, and preoperative treatment with high-risk drugs. CONCLUSIONS: SP and NCSP are feasible by laparoscopy, with low morbidity rate, confirming the advantages of both minimally invasive and conservative surgery.

A Protocol is not Enough: Enhanced Recovery Program-Based Care and Clinician Adherence Associated with Shorter Stay After Colorectal Surgery.

BACKGROUND: Randomised trials have shown an Enhanced Recovery Program (ERP) can shorten stay after colorectal surgery. Previous research has focused on patient compliance neglecting the role of care providers. National data on implementation and adherence to standardised care are lacking. We examined care organisation and delivery including the ERP, and correlated this with clinical outcomes. METHODS: A cross-sectional questionnaire was administered to surgeons and nurses in August-October 2015. All English National Health Service Trusts providing elective colorectal surgery were invited. Responses frequencies and variation were examined. Exploratory factor analysis was performed to identify underlying features of care. Standardised factor scores were correlated with elective clinical outcomes of length of stay, mortality and readmission rates from 2013-15. RESULTS: 218/600 (36.3%) postal responses were received from 84/90 (93.3%) Trusts that agreed to participate. Combined with email responses, 301 surveys were analysed. 281/301 (93.4%) agreed or strongly agreed that they had a standardised, ERP-based care protocol. However, 182/301 (60.5%) indicated all consultants managed post-operative oral intake similarly. After factor analysis, higher hospital average ERP-based care standardisation and clinician adherence score were significantly correlated with reduced length of stay, as well as higher ratings of teamwork and support for complication management. CONCLUSIONS: Standardised, ERP-based care was near universal, but clinician adherence varied markedly. Units reporting higher levels of clinician adherence achieved the lowest length of stay. Having a protocol is not enough. Careful implementation and adherence by all of the team is vital to achieve the best results.

What Are the Cost Drivers for the Major Bowel Bundled Payment Care Improvement Initiative?

BACKGROUND: The Bundled Payments for Care Improvement initiative links payments for service beneficiaries during an episode of care (limited to 90 days from index surgery discharge). OBJECTIVE: The purpose of this study was to identify drivers of costs/payments for the major bowel Bundled Payments for Care Improvement initiative. DESIGN: Discharges from the Medicare Standard Analytic Files of hospitals participating in the major bowel bundle of the Bundled Payments for Care Improvement initiative were analyzed. SETTINGS: The study was conducted at 4 tertiary care centers. PATIENTS: All patients in diagnostic related groups of 329, 330, or 331 treated at eligible facilities between September 1, 2012, and September 30, 2014, were included. MAIN OUTCOME MEASURES: We calculated all costs/payments for the bundled period, that is, 3 days before surgery, the index hospitalization including surgery, and the 90-day postoperative period. We then determined costs for laparoscopic versus open procedures using International Classification of Diseases, Ninth Revision, procedure codes for each of the diagnostic related groups, as well as in aggregate. Last, we calculated differential impact of cost drivers on overall total episode costs. RESULTS: In the cohort of hospitals participating in the major bowel Bundled Payments for Care Improvement initiative, open procedures ($45,073) cost 1.6 times more than laparoscopic. For the lowest complexity diagnostic related group (331), performance of the procedure with open techniques was the largest total episode cost driver, because use of postdischarge services remained low. In the highest complexity diagnostic related group (329), readmission costs, skilled nursing facilities costs, and home health services costs were the greatest cost drivers after hospital services. LIMITATIONS: The analyses are limited by the retrospective nature of the study. CONCLUSIONS: These results indicate that efforts to safely perform open procedures with laparoscopic techniques would be most effective in reducing costs for lower complexity diagnostic related groups, whereas efforts to impact readmission and postdischarge service use would be most impactful for the higher complexity diagnostic related groups. See Video Abstract at http://links.lww.com/DCR/B420. ¿CUÁLES SON LOS FACTORES DETERMINANTES DE LOS COSTOS DE LA INICIATIVA DE MEJORA DE LA ATENCIÓN DE PAGOS COMBINADOS PARA EL INTESTINO MAYOR?: La iniciativa de pagos combinados para la mejora de la atención (BPCI) vincula los pagos para los beneficiarios del servicio durante un episodio de atención (limitado a 90 días desde el alta hospitalaria de la cirugía índice).Identificar los factores determinantes de los costos / pagos de la iniciativa BPCI intestinal mayor.Análisis de altas de los Archivos Analíticos Estándar de Medicare de los hospitales que participan en el paquete intestinal principal de la iniciativa BPCI.Todos los pacientes en Grupos Relacionados con el Diagnóstico (GRD) de 329, 330 o 331 tratados en instalaciones elegibles desde el 1 de Septiembre de 2012 hasta el 30 de Septiembre de 2014.Calculamos todos los costos / pagos para el período combinado, es decir, tres días antes de la cirugía, el índice de hospitalización incluida la cirugía y el período posoperatorio de 90 días. Luego, determinamos los costos de los procedimientos laparoscópicos versus abiertos utilizando códigos de procedimiento ICD-9 para cada uno de los GRD, así como en conjunto. Por último, calculamos el impacto diferencial de los generadores de costos sobre los costos totales del episodio.En la cohorte de hospitales que participan en la iniciativa BPCI del intestino principal, los procedimientos abiertos ($ 45.073) cuestan 1,6 veces más que los laparoscópicos. Para el GRD de menor complejidad (331), la realización del procedimiento con técnicas abiertas fue el mayor factor de costo total del episodio, ya que la utilización de los servicios posteriores al alta se mantuvo baja. En el GRD de mayor complejidad (329), los costos de readmisión, los costos de las instalaciones de enfermería especializada y los costos de los servicios de salud en el hogar fueron los mayores factores de costo después de los servicios hospitalarios.Los análisis están limitados por la naturaleza retrospectiva del estudio.Estos resultados indican que los esfuerzos para realizar procedimientos abiertos de manera segura con técnicas laparoscópicas serían más efectivos para reducir los costos de los GRD de menor complejidad, mientras que los esfuerzos para impactar la readmisión y la utilización del servicio posterior al alta serían más impactantes para los GRD de mayor complejidad. See Video Abstract at http://links.lww.com/DCR/B420.

The quality of lymph node harvests in extralevator abdominoperineal excisions.

BACKGROUND: Lymph node (LN) harvest in colorectal cancer resections is a well-recognised prognostic factor for disease staging and determining survival, particularly for node-negative (N0) diseases. Extralevator abdominoperineal excisions (ELAPE) aim to prevent "waisting" that occurs during conventional abdominoperineal resections (APR) for low rectal cancers, and reducing circumferential resection margin (CRM) infiltration rate. Our study investigates whether ELAPE may also improve the quality of LN harvests, addressing gaps in the literature. METHODS: This retrospective observational study reviewed 2 sets of 30 consecutive APRs before and after the adoption of ELAPE in our unit. The primary outcomes are the total LN counts and rates of meeting the standard of 12-minimum, particularly for those with node-negative disease. The secondary outcomes are the CRM involvement rates. Baseline characteristics including age, sex, laparoscopic or open surgery and the use of neoadjuvant chemoradiotherapy were accounted for in our analyses. RESULTS: Median LN counts were slightly higher in the ELAPE group (16.5 vs. 15). Specimens failing the minimum 12-LN requirements were almost significantly fewer in the ELAPE group (OR 0.456, P = 0.085). Among node-negative rectal cancers, significantly fewer resections failed the 12-LN standard in the ELAPE group than APR group (OR 0.211, P = 0.044). ELAPE led to a near-significant decrease in CRM involvement (OR 0.365, P = 0.088). These improvements were persistently observed after taking into account baselines and potential confounders in regression analyses. CONCLUSION: ELAPE provides higher quality of LN harvests that meet the 12-minimal requirements than conventional APR, particularly in node-negative rectal cancers. The superiority is independent of potential confounding factors, and may implicate better clinical outcomes.

A baseline assessment of enhanced recovery protocol implementation at pediatric surgery practices performing inflammatory bowel disease operations.

BACKGROUND: Enhanced recovery protocols (ERPs) have been used to improve patient outcomes and resource utilization after surgery. These evidence-based interventions include patient education, standardized anesthesia protocols, and limited fasting, but their use among pediatric populations is lagging. We aimed to determine baseline recovery practices within pediatric surgery departments participating in an ERP implementation trial for elective inflammatory bowel disease (IBD) operations. METHODS: To measure baseline ERP adherence, we administered a survey to a staff surgeon in each of the 18 participating sites. The survey assessed demographics of each department and utilization of 21 recovery elements during patient encounter phases. Mixed-methods analysis was used to evaluate predictors and barriers to ERP element implementation. RESULTS: The assessment revealed an average of 6.3 ERP elements being practiced at each site. The most commonly practiced elements were using minimally invasive techniques (100%), avoiding intraabdominal drains (89%), and ileus prophylaxis (72%). The preoperative phase had the most elements with no adherence including patient education, optimizing medical comorbidities, and avoiding prolonged fasting. There was no association with number of elements utilized and total number of surgeons in the department, annual IBD surgery volume, and hospital size. Lack of buy-in from colleagues, electronic medical record adaptation, and resources for data collection and analysis were identified barriers. CONCLUSIONS: Higher intervention utilization for IBD surgery was associated with elements surgeons directly control such as use of laparoscopy and avoiding drains. Elements requiring system-level changes had lower use. The study characterizes the scope of ERP utilization and the need for effective tools to improve adoption. LEVEL OF EVIDENCE: Level III. TYPE OF STUDY: Mixed-methods survey.

Impact of surgical indication on patient outcomes and compliance with enhanced recovery program for colorectal surgery: A Francophone multicenter retrospective analysis.

BACKGROUND AND OBJECTIVE: The impact of surgical indication on compliance with enhanced recovery program (ERP) and on outcomes has never been assessed. This study aims to assess the impact of surgical indication (malignant vs benign) on postoperative outcomes and ERP compliance. METHODS: A multicenter nationwide database was analyzed. Patients who underwent colorectal surgery for benign disease and those who underwent colorectal surgery for cancer were compared. Inclusion criteria were elective colorectal resection with anastomosis. ERP components, postoperative morbidity, and hospital length of hospital stay data were collected. RESULTS: Among the 6472 patients registered in the database between October 2012 and June 2018, 4528 patients were included; 2647 in the malignant group and 1881 in the benign group. The ERP compliance over 70% was not different between groups. Postoperative morbidity rate was higher in the malignant group (22.5% vs 19.3%; P = .009) but not confirmed in multivariate analysis. Patients in the malignant group were more often readmitted after discharge, 6.6% vs 4.6% (P = .004). The mean LOS was 6.3 ± 5.0 days in the malignant group and 5.4 ± 4.7 days in the benign group (P < .001). CONCLUSIONS: Indication for colorectal surgery did not significantly influence peri-operative management and postoperative major complications, in patients managed within an enhanced recovery program.

[Experience of teaching and training for medical students at gastrointestinal surgery department under COVID-19 epidemic situation].

In hospitals and medical schools as densely populated sites with high risk of coronavirus disease 2019 (COVID-19), it is vital to adjust the teaching and training strategy for medical students to ensure curriculum completion with safety. This article aims to introduce the experience of teaching and training for medical students under the epidemic situation at Department of Surgery, Shanghai Medical College, Fudan University and Zhongshan Hospital. The content includes exploring diversified online teaching models for undergraduate surgery courses and clinical practice, carrying out online graduate education and dissertation plans, and strengthening comprehensive education of medical humanity combined with knowledge of COVID-19 prevention. Through implementation of the above teaching strategies, scheduled learning plans of medical students can be well completed in an orderly, safe and quality-ensured manner. Our experience provides practical solution of medical teaching and could be advisable for other medical colleges and teaching hospitals.

Hand hygiene in surgery in Benin: opportunities and challenges.

BACKGROUND: Hand Hygiene (HH) has been described as the cornerstone and starting point in all infection control. Compliance to HH is a fundamental quality indicator. The aim of this study was to investigate the HH compliance among Health-care Workers (HCWs) in Benin surgical care units. METHODS: A multicenter prospective observational study was conducted for two months. The World Health Organization (WHO) Hand Hygiene Observation Tool was used in obstetric and gastrointestinal surgery through six public hospitals in Benin. HH compliance was calculated by dividing the number of times HH was performed by the total number of opportunities. HH technique and duration were also observed. RESULTS: A total of 1315 HH opportunities were identified during observation period. Overall, the compliance rate was 33.3% (438/1315), without significant difference between professional categories (nurses =34.2%; auxiliaries =32.7%; and physicians =32.4%; p = 0.705). However, compliance rates differed (p < 0.001) between obstetric (49.4%) and gastrointestinal surgery (24.3%). Generally, HCWs were more compliant after body fluid exposure (54.5%) and after touching patient (37.5%), but less before patient contact (25.9%) and after touching patient surroundings (29.1%). HCWs were more likely to use soap and water (72.1%) compared to the alcohol based hand rub solution (27.9%). For all of the WHO five moments, hand washing was the most preferred action. For instance, hand rub only was observed 3.9% after body fluid exposure and 16.3% before aseptic action compared to hand washing at 50.6 and 16.7% respectively. Duration of HH performance was not correctly adhered to 94% of alcohol hand rub cases (mean duration 9 ± 6 s instead of 20 to 30 s) and 99.5% of hand washing cases (10 ± 7 s instead of the recommended 40 to 60 s). Of the 432 HCWs observed, 77.3% followed HH prerequisites (i.e. no artificial fingernails, no jewellery). We also noted a lack of permanent hand hygiene infrastructures such as sink, soap, towels and clean water. CONCLUSION: Compliance in surgery was found to be low in Benin hospitals. They missed two opportunities out of three to apply HH and when HH was applied, technique and duration were not appropriate. HH practices should be a priority to improve patient safety in Benin.

Standardized Method of the Thiersch Operation for the Treatment of Fecal Incontinence.

BACKGROUND: Conventionally, the Thiersch operation has typically involved blind positioning of the sling, and sling tension is subjectively based on a rule-of-thumb estimate. The aim of this study was to describe standardized methods for performing the Thiersch operation. METHODS: Seventeen patients with fecal incontinence underwent the calibrated method of the Thiersch procedure. As an encircling sling, a 6-mm-wide silastic tube was used. Through 4 minimal perianal skin incisions, the sling was placed proximal to the anal skin 3 cm from the anal verge and 4 cm in depth. The circumference of the sling was 10 cm in length. Results were assessed by clinical responses and by comparing pre- and postoperative Wexner scores. The data were collected retrospectively. RESULTS: The median follow-up period was 9 months (range 6-19). In 16 out of 17 fecal incontinence patients (94.1%), the median Wexner incontinence score was 0 (range 0-3) postoperatively. Localized sepsis developed in three cases (17.7%, 3/17), which were controlled with drainage and antibiotics. Fecal impaction occurred in one case (5.9%, 1/17). There was no removal or breakage of the inserted sling. CONCLUSIONS: The elasticity of the silastic tube reduced the incidence of sling breakage. According to the standardized method, the sling was placed external to the external anal sphincter muscle and at the junction of the external anal sphincter muscle and puborectalis muscle. Fecal incontinence was controlled effectively, and the incidence of fecal impaction was negligible. High reproducibility was observed with this method.

Consensus Guidelines for Perioperative Care in Neonatal Intestinal Surgery: Enhanced Recovery After Surgery (ERAS®) Society Recommendations.

BACKGROUND: Enhanced Recovery After Surgery (ERAS®) Society guidelines integrate evidence-based practices into multimodal care pathways that have improved outcomes in multiple adult surgical specialties. There are currently no pediatric ERAS® Society guidelines. We created an ERAS® guideline designed to enhance quality of care in neonatal intestinal resection surgery. METHODS: A multidisciplinary guideline generation group defined the scope, population, and guideline topics. Systematic reviews were supplemented by targeted searching and expert identification to identify 3514 publications that were screened to develop and support recommendations. Final recommendations were determined through consensus and were assessed for evidence quality and recommendation strength. Parental input was attained throughout the process. RESULTS: Final recommendations ranged from communication strategies to antibiotic use. Topics with poor-quality and conflicting evidence were eliminated. Several recommendations were combined. The quality of supporting evidence was variable. Seventeen final recommendations are included in the proposed guideline. DISCUSSION: We have developed a comprehensive, evidence-based ERAS guideline for neonates undergoing intestinal resection surgery. This guideline, and its creation process, provides a foundation for future ERAS guideline development and can ultimately lead to improved perioperative care across a variety of pediatric surgical specialties.

How should colorectal surgeons practice during the COVID-19 epidemic? A retrospective single-centre analysis based on real-world data from China.

BACKGROUND: The coronavirus disease 2019 is currently of global concern. Cancer patients are advised to stay at home in case of potential infection, which may cause delays of routine diagnosis and necessary treatment. How colorectal surgeons should manage this during the epidemic remains a big challenge. The objective of the study is to evaluate the feasibility of routine colorectal surgery during coronavirus disease 2019 and to offer some Chinese recommendations to colorectal surgeons throughout the world. METHODS: A total of 166 patients receiving colorectal surgery from 20 December 2019 to 20 March 2020 at Department of General Surgery in Chinese General Hospital of People's Liberation Army were enrolled, and further divided into two groups based on before or after admission date of 20 January 2020. Clinicopathologic data such as hospital stay and economic data such as total costs were collected and analysed retrospectively. RESULTS: Longer hospital stay, higher proportion of non-local patients and more hospitalization cost were found in the post-20 January group (special-time group) (P < 0.001; P < 0.05; P < 0.05, respectively). Apart from this, no difference existed with regard to baseline demographical data such as age, sex and height, as well as clinicopathological data such as previous history, surgery time, operation extent and TNM staging. CONCLUSIONS: This real-world study indicated that performing colorectal surgery during coronavirus disease 2019 epidemic might be safe and feasible based on comprehensive screening and investigation. We have summarized several recommendations here, hoping to help surgeons from related departments across the world.

Influence of hospital teaching status on the chance to achieve a textbook outcome after hepatopancreatic surgery for cancer among Medicare beneficiaries.

BACKGROUND: Assessing composite measures of quality such as textbook outcome may be superior to focusing on individual parameters when evaluating hospital performance. The aim of the current study was to assess the impact of teaching hospital status on the occurrence of a textbook outcome after hepatopancreatic surgery. METHODS: The Medicare Inpatient Standard Analytic Files were used to identify patients undergoing hepatopancreatic surgery from 2013 to 2015 for a malignant indication. Stratified and multivariable regression analyses were performed to determine the relationship between teaching hospital status, hospital surgical volume and textbook outcome. RESULTS: Among 8,035 Medicare patients (hepatectomy; 41.8%, pancreatectomy; 58.2%), 6,196 (77.1%) patients underwent surgery at a major teaching hospital, whereas 1,839 (22.9%) patients underwent surgery at a minor teaching hospital. Patients undergoing surgery for pancreatic cancer at a major teaching hospital had a greater likelihood of achieving a textbook outcome compared with patients treated at a minor teaching hospital (minor teaching hospital: 456, 40% versus major teaching hospital: 1,606, 45.4%; P = .002). The likelihood of textbook outcome was also greater among patients undergoing hepatopancreatic surgery at high-volume centers (pancreas, low volume: 875, 40.5% versus high volume: 1,187, 47.1% P < .001; liver, low volume: 608, 41.8% versus high volume: 886, 46.6%; P = .005). When examining only major teaching hospitals, patients undergoing a pancreatectomy at a high-volume center had 29% greater odds of achieving a textbook outcome (odds ratio 1.29, 95% confidence interval 1.12-1.49). In contrast, among patients undergoing pancreatic resection at high-volume centers, the odds of achieving a textbook outcome was comparable among major versus minor teaching hospital (odds ratio 1.17, 95% confidence interval 0.89-1.53). CONCLUSION: The odds of achieving a textbook outcome after pancreatic and hepatic surgery was greater at major versus minor teaching hospitals; however, this effect was largely mediated by hepatopancreatic procedural volume. Patients and payers should focus on regionalization of pancreatic and liver resection to high-volume centers in an effort to optimize the chances of achieving a textbook outcome.

Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib.

Importance: The association between quality of surgery and overall survival in patients affected by localized gastrointestinal stromal tumors (GIST) is not completely understood. Objective: To assess the risk of death with and without imatinib according to microscopic margins status (R0/R1) using data from a randomized study on adjuvant imatinib. Design, Setting, and Participants: This is a post hoc observational study on patients included in the randomized, open-label, phase III trial, performed between December 2004 and October 2008. Median follow-up was 9.1 years (IQR, 8-10 years). The study was performed at 112 hospitals in 12 countries. Inclusion criteria were diagnosis of primary GIST, with intermediate or high risk of relapse; no evidence of residual disease after surgery; older than 18 years; and no prior malignancies or concurrent severe/uncontrolled medical conditions. Data were analyzed between July 17, 2017, and March 1, 2020. Interventions: Patients were randomized after surgery to either receive imatinib (400 mg/d) for 2 years or no adjuvant treatment. Randomization was stratified by center, risk category (high vs intermediate), tumor site (gastric vs other), and quality of surgery (R0 vs R1). Tumor rupture was included in the R1 category but also analyzed separately. Main Outcomes and Measures: Primary end point of this substudy was overall survival (OS), estimated using Kaplan-Meier method and compared between R0/R1 using Cox models adjusted for treatment and stratification factors. Results: A total of 908 patients were included; 51.4% were men (465) and 48.6% were women (440), and the median age was 59 years (range, 18-89 years). One hundred sixty-two (17.8%) had an R1 resection, and 97 of 162 (59.9%) had tumor rupture. There was a significant difference in OS for patients undergoing an R1 vs R0 resection, overall (hazard ratio [HR], 2.05; 95% CI, 1.45-2.89) and by treatment arm (HR, 2.65; 95% CI, 1.37-3.75 with adjuvant imatinib and HR, 1.86; 95% CI, 1.16-2.99 without adjuvant imatinib). When tumor rupture was excluded, this difference in OS between R1 and R0 resections disappeared (HR, 1.05; 95% CI, 0.54-2.01). Conclusions and Relevance: The difference in OS by quality of surgery with or without imatinib was associated with the presence of tumor rupture. When the latter was excluded, the presence of R1 margins was not associated with worse OS. Trial Registration: ClinicalTrials.gov Identifier: NCT00103168.

Impact of technically qualified surgeons on laparoscopic colorectal resection outcomes: results of a propensity score-matching analysis.

BACKGROUND: The Endoscopic Surgical Skill Qualification System (ESSQS) was introduced in Japan to improve the quality of laparoscopic surgery. This cohort study investigated the short- and long-term postoperative outcomes of colorectal cancer laparoscopic procedures performed by or with qualified surgeons compared with outcomes for unqualified surgeons. METHODS: All laparoscopic colorectal resections performed from 2010 to 2013 in 11 Japanese hospitals were reviewed retrospectively. The procedures were categorized as performed by surgeons with or without the ESSQS qualification and patients' clinical, pathological and surgical features were used to match subgroups using propensity scoring. Outcome measures included postoperative and long-term results. RESULTS: Overall, 1428 procedures were analysed; 586 procedures were performed with ESSQS-qualified surgeons and 842 were done by ESSQS-unqualified surgeons. Upon matching, two cohorts of 426 patients were selected for comparison of short-term results. A prevalence of rectal resection (50·3 versus 40·5 per cent; P < 0·001) and shorter duration of surgery (230 versus 238 min; P = 0·045) was reported for the ESSQS group. Intraoperative and postoperative complication and reoperation rates were significantly lower in the ESSQS group than in the non-ESSQS group (1·2 versus 3·6 per cent, P = 0·014; 4·6 versus 7·5 per cent, P = 0·025; 1·9 versus 3·9 per cent, P = 0·023, respectively). These findings were confirmed after propensity score matching. Cox regression analysis found that non-attendance of ESSQS-qualified surgeons (hazard ratio 12·30, 95 per cent c.i. 1·28 to 119·10; P = 0·038) was independently associated with local recurrence in patients with stage II disease. CONCLUSION: Laparoscopic colorectal procedures performed with ESSQS-qualified surgeons showed improved postoperative results. Further studies are needed to investigate the impact of the qualification on long-term oncological outcomes.

ANTECEDENTES: El Sistema de Certificación de Habilidades Quirúrgicas Endoscópicas (Endoscopic Surgical Skill Qualification System, ESSQS) fue introducido en Japón para mejorar la calidad de la cirugía laparoscópica. En este estudio de cohortes se investigaron los resultados postoperatorios a corto y a largo plazo de las intervenciones laparoscópicas de cáncer colorrectal realizadas por o con la asistencia de cirujanos con certificación en comparación con cirujanos no certificados. MÉTODOS: Todas las resecciones colorrectales laparoscópicas realizadas entre 2010 y 2013 en 11 hospitales japoneses fueron revisadas retrospectivamente. Los procedimientos se clasificaron en función de si habían sido realizados por cirujanos con o sin certificación del ESSQS, y las características clínicas, patológicas y quirúrgicas de los pacientes se utilizaron para emparejar los subgrupos mediante puntuaciones de propensión. Las variables de resultado incluyeron los resultados postoperatorios y a largo plazo RESULTADOS: En total se analizaron 1.428 procedimientos, incluyendo 586 y 842 procedimientos realizados con y sin cirujanos certificados por ESSQS, respectivamente. Tras el emparejamiento, se seleccionaron dos cohortes de 426 pacientes para la comparación de resultados a corto plazo. Se observó una mayor prevalencia de resecciones rectales (50,3% versus 40,1%, P = 0,0001) y un tiempo quirúrgico más corto (230 versus 238 min, P = 0,04) en el grupo ESSQS. Las tasas de complicaciones intra- y postoperatorias y de reoperaciones fueron significativamente más bajas en el grupo ESSQS que en el grupo no ESSQS (1,2%, 4,6% y 1,9% versus 3,6%, 7,5% y 3,9%, P = 0,01; 0,03, y 0,02, respectivamente). Estos hallazgos se confirmaron tras el análisis de emparejamiento por puntaje de propensión. El análisis de regresión de Cox mostró que la no participación de cirujanos certificados con ESSQS (razón de oportunidades, odds ratio, OR 12,3; i.c. del 95%, 1,28-119,1; P = 0,03) se asoció independientemente con la recidiva local en los casos en estadio II. CONCLUSIÓN: Los procedimientos colorrectales laparoscópicos realizados por cirujanos certificados por ESSQS presentaron mejores resultados postoperatorios. Son necesarios más estudios para determinar el impacto de la certificación en los resultados oncológicos a largo plazo.

Am I out of control? The application of statistical process control charts to children's surgery.

AIMS: To illustrate the construction of statistical control charts and show their potential application to analysis of outcomes in children's surgery. PATIENTS AND METHODS: Two datasets recording outcomes following esophageal atresia repair and intestinal resection for Crohn's disease maintained by the author were used to construct four types of charts. The effects of altering the target signal, the alarm signal and the limits are illustrated. The dilemmas in choice of target rate are described. Simulated data illustrate the advantages over hypothesis testing. RESULTS: The charts show the author's institutional leak rate for esophageal atresia repair may be within acceptable limits, but that this is dependent on the target set. The desirable target is contentious. The leak rate for anastomoses following intestinal resection for Crohn's disease leak is also within acceptable limits when compared to published experience, but may be deteriorating. The charts are able to detect deteriorating levels of performance well before hypothesis testing would suggest a systematic problem with outcomes. CONCLUSIONS: Statistical process control charts can provide surgeons with early warning of systematic poor performance. They are robust to volume-outcome influences, since the outcome is tested sequentially after each procedure or patient. They have application in a specialty with low frequencies of operations such as children's surgery. TYPE OF STUDY: Diagnostic test. LEVEL OF EVIDENCE: Level II.

A NSQIP analysis of trends in surgical outcomes for rectal cancer: What can we improve upon?

BACKGROUND: There is significant variation in rectal cancer outcomes in the USA, and reported outcomes have been inferior to those in other countries. In recognition of this fact, the American College of Surgeons (ACS) recently launched the Commission on Cancer (CoC) National Accreditation Program for Rectal Cancer (NAPRC) in an effort to further optimize rectal cancer care. Large surgical databases will play an important role in tracking surgical and oncologic outcomes. Our study sought to explore the trends in surgical outcomes over the decade prior to the NAPRC using a large national database. METHODS: The ACS National Surgical Quality Improvement Program (NSQIP) database from 2005 to 2017 was used to select colorectal cancer cases which were divided into abdominal-colonic (AC) and pelvic-rectal (PR) cohorts based upon the operation performed. Outcomes of interest were occurrence of any major surgical complication, mortality within 30 days of procedure, and postoperative length of stay (LOS). Chi-square and two sample t-tests were used to evaluate association between various risk factors and outcomes. Modified Poisson regression was used to compare and estimate the unadjusted and adjusted effect of procedure type on the outcomes. STATA 15.1 was used for analysis and statistical significance was set at 0.05. RESULTS: A total of 34,159 patients were analyzed. AC cases constituted 50.7% of the overall cohort. The two groups were relatively similar in demographic distribution, but the PR patients had higher rates of hypoalbuminemia and were sicker (ASA class 3 or greater). Rates of non-sphincter preserving operations ranged from 30 to 34%. Higher complication rates in the PR cohort were mainly infectious and surgical site complications, while rates of deep vein thrombosis and pulmonary embolism were similar between the two cohorts. On bivariate analysis, rates of mortality were similar between the two groups (AC: 1.02% vs PR: 0.91%, p = 0.395), while PR patients were found to be 1.36 times (95% CI: 1.32-1.41) more likely to have major complications and 1.40 times (95% CI: 1.35-1.44) more likely to have an extended LOS as compared to the AC patients. After multivariable analysis, PR patients continued to have a higher likelihood of major complications (IRR: 1.31, 95% CI 1.25-1.36) and extended LOS (IRR: 1.38, 95% CI: 1.33-1.43). 10-year trends showed a significant reduction in the percentage of patients with prolonged lengths of hospitalization as well as a reduction of nearly 20% in the mean LOS, but without improvement in morbidity or mortality. CONCLUSIONS: Patients undergoing PR operations were more likely to have had major complications than were patients who underwent AC procedures; unfortunately no improvement in the rate of these complications or in mortality occurred. Perhaps the significant reduction in LOS is due in part to an increased prevalence of minimally invasive surgery and/or enhanced recovery protocols. Data were found to be lacking within NSQIP for several important variables including key oncologic data, stratification by surgical volume, and patient geographic location. We anticipate that the NAPRC should help improve PR surgical and oncologic outcomes including decreasing morbidity and mortality rates during the next decade.